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A Study of the Efficacy and Safety of Asenapine in Participants With an Acute Exacerbation of Schizophrenia (P05688)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01617187
Recruitment Status : Completed
First Posted : June 12, 2012
Results First Posted : August 31, 2015
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Schizophrenia
Interventions Drug: Asenapine
Drug: Placebo Asenapine
Drug: Olanzapine
Drug: Placebo Olanzapine
Enrollment 360
Recruitment Details  
Pre-assignment Details One participant randomized to asenapine 2.5 mg BID did not receive study drug but was recorded in clinical database as completing the study. In Participant Flow table, this participant is presented as Not Completed in period "Randomization through Start Treatment" (Not Treated).
Arm/Group Title Asenapine 2.5 mg BID Asenapine 5 mg BID Olanzapine 15 mg QD Placebo BID
Hide Arm/Group Description Participants were administered one 2.5 mg asenapine tablet twice daily (BID) for 42 days Participants were administered one 5 mg asenapine tablet BID for 42 days Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) once daily (QD) for 42 days, except during Week 1 olanzapine 10 mg QD was administered Participants were administered placebo tablets BID for 42 days
Period Title: Randomization Through Start Treatment
Started 98 [1] 113 [1] 46 [1] 103 [1]
Completed 97 113 46 101
Not Completed 1 0 0 2
Reason Not Completed
Not Treated: Administrative Reason             0             0             0             1
Not Treated: Adverse Event             0             0             0             1
Not Treated: Completed study in database             1             0             0             0
[1]
Randomized
Period Title: Treatment Through Study Completion
Started 97 [1] 113 [1] 46 [1] 101 [1]
Completed 86 [2] 102 41 91
Not Completed 11 11 5 10
Reason Not Completed
Adverse Event             1             1             0             1
Lost to Follow-up             4             2             2             2
Withdrawal by Subject             5             8             3             6
Protocol Violation             1             0             0             1
[1]
Treated
[2]
Excludes the participant who did not receive study drug but completed study in database
Arm/Group Title Asenapine 2.5 mg BID Asenapine 5 mg BID Olanzapine 15 mg QD Placebo BID Total
Hide Arm/Group Description Participants were administered one 2.5 mg asenapine tablet BID for 42 days Participants were administered one 5 mg asenapine tablet BID for 42 days Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered Participants were administered placebo tablets BID for 42 days Total of all reporting groups
Overall Number of Baseline Participants 97 113 46 101 357
Hide Baseline Analysis Population Description
All randomized participants who received ≥1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 97 participants 113 participants 46 participants 101 participants 357 participants
41.5  (10.79) 39.1  (10.68) 40.8  (11.15) 41.4  (12.05) 40.6  (11.18)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 97 participants 113 participants 46 participants 101 participants 357 participants
Female
39
  40.2%
44
  38.9%
18
  39.1%
47
  46.5%
148
  41.5%
Male
58
  59.8%
69
  61.1%
28
  60.9%
54
  53.5%
209
  58.5%
Positive and Negative Syndrome Scale (PANSS) total score   [1] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 97 participants 113 participants 46 participants 101 participants 357 participants
93.3  (11.10) 95.8  (13.77) 92.7  (10.47) 93.4  (11.16) 94.1  (11.97)
[1]
Measure Description: The PANSS is a 30-item scale for assessing the symptoms of schizophrenia. For each PANSS item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS total score (30 items) ranged from 30 to 210 with a higher score indicating greater severity of symptoms. Summary statistics presented are for efficacy population (Full Analysis Set [FAS]): N=96, 111, 45, 99 and 351 for asenapine 2.5 mg BID, asenapine 5 mg BID, olanzapine 15 mg QD, placebo BID and Total groups, respectively.
Clinical Global Impression Scale-Severity (CGI-S) score   [1] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 97 participants 113 participants 46 participants 101 participants 357 participants
4.8  (0.64) 4.9  (0.64) 4.8  (0.61) 4.8  (0.61) 4.8  (0.63)
[1]
Measure Description: CGI-S is a 7-point scale for assessing the global severity of the participant’s illness, with ratings from 1=normal, not ill to 7=very severely ill. Summary statistics presented are for efficacy population (FAS): N=96, 111, 45, 99 and 351 for asenapine 2.5 mg BID, asenapine 5 mg BID, olanzapine 15 mg QD, placebo BID and Total groups, respectively.
Body Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 97 participants 113 participants 46 participants 101 participants 357 participants
81.6  (17.73) 78.6  (17.88) 80.7  (17.79) 77.1  (17.56) 79.3  (17.75)
PANSS negative subscale score   [1] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 97 participants 113 participants 46 participants 101 participants 357 participants
23.5  (4.47) 24.1  (4.50) 23.4  (3.96) 23.9  (4.22) 23.8  (4.34)
[1]
Measure Description: The PANSS is a 30-item scale for assessing the symptoms of schizophrenia. For each PANSS item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS negative subscale score (7 PANSS items) ranged from 7 to 49 with a higher score indicating greater severity of symptoms. Summary statistics presented are for efficacy population (FAS): N=96, 111, 45, 99 and 351 for asenapine 2.5 mg BID, asenapine 5 mg BID, olanzapine 15 mg QD, placebo BID and Total groups, respectively.
PANSS positive subscale score   [1] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 97 participants 113 participants 46 participants 101 participants 357 participants
24.4  (4.05) 25.5  (4.76) 24.6  (3.46) 24.6  (3.88) 24.8  (4.19)
[1]
Measure Description: The PANSS is a 30-item scale for assessing the symptoms of schizophrenia. For each PANSS item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS positive subscale score (7 PANSS items) ranged from 7 to 49 with a higher score indicating greater severity of symptoms. Summary statistics presented are for efficacy population (FAS): N=96, 111, 45, 99 and 351 for asenapine 2.5 mg BID, asenapine 5 mg BID, olanzapine 15 mg QD, placebo BID and Total groups, respectively.
PANSS general psychopathology subscale score   [1] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 97 participants 113 participants 46 participants 101 participants 357 participants
45.5  (6.05) 46.3  (6.87) 44.7  (6.20) 44.9  (6.05) 45.5  (6.34)
[1]
Measure Description: The PANSS is a 30-item scale for assessing the symptoms of schizophrenia. For each PANSS item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS general psychopathology subscale score (16 PANSS items) ranged from 16 to 112 with a higher score indicating greater severity of symptoms. Summary statistics presented are for efficacy population (FAS): N=96, 111, 45, 99 and 351 for asenapine 2.5 mg BID, asenapine 5 mg BID, olanzapine 15 mg QD, placebo BID and Total groups, respectively.
PANSS Marder factor positive symptom score   [1] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 97 participants 113 participants 46 participants 101 participants 357 participants
29.3  (5.02) 30.0  (5.05) 29.0  (4.69) 29.4  (4.36) 29.5  (4.80)
[1]
Measure Description: The PANSS is a 30-item scale for assessing the symptoms of schizophrenia. For each PANSS item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS Marder factor positive symptom score (calculated from value of 8 identified PANSS items) ranged from 8 to 56 with a higher score indicating greater severity of symptoms. Summary statistics presented are for efficacy population (FAS): N=96, 111, 45, 99 and 351 for asenapine 2.5 mg BID, asenapine 5 mg BID, olanzapine 15 mg QD, placebo BID and Total groups, respectively.
PANSS Marder factor negative symptom score   [1] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 97 participants 113 participants 46 participants 101 participants 357 participants
22.6  (4.30) 23.0  (4.66) 23.0  (4.44) 22.8  (4.76) 22.8  (4.55)
[1]
Measure Description: The PANSS is a 30-item scale for assessing the symptoms of schizophrenia. For each PANSS item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS Marder factor negative symptom score (calculated from value of 7 identified PANSS items) ranged from 7 to 49 with a higher score indicating greater severity of symptoms. Summary statistics presented are for efficacy population (FAS): N=96, 111, 45, 99 and 351 for asenapine 2.5 mg BID, asenapine 5 mg BID, olanzapine 15 mg QD, placebo BID and Total groups, respectively.
PANSS Marder factor disorganized thought symptom score   [1] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 97 participants 113 participants 46 participants 101 participants 357 participants
21.5  (4.32) 22.6  (4.93) 21.2  (4.29) 21.6  (4.42) 21.8  (4.56)
[1]
Measure Description: The PANSS is a 30-item scale for assessing the symptoms of schizophrenia. For each PANSS item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS Marder factor disorganized thought symptom score (calculated from value of 7 identified PANSS items) ranged from 7 to 49 with a higher score indicating greater severity of symptoms. Summary statistics presented are for efficacy population (FAS): N=96, 111, 45, 99 and 351 for asenapine 2.5 mg BID, asenapine 5 mg BID, olanzapine 15 mg QD, placebo BID and Total groups, respectively.
PANSS Marder factor hostility/excitement symptom score   [1] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 97 participants 113 participants 46 participants 101 participants 357 participants
9.0  (2.99) 9.4  (3.49) 8.7  (3.11) 8.8  (3.22) 9.0  (3.23)
[1]
Measure Description: The PANSS is a 30-item scale for assessing the symptoms of schizophrenia. For each PANSS item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS Marder factor hostility/excitement symptom score (calculated from value of 4 identified PANSS items) ranged from 4 to 28 with a higher score indicating greater severity of symptoms. Summary statistics presented are for efficacy population (FAS): N=96, 111, 45, 99 and 351 for asenapine 2.5 mg BID, asenapine 5 mg BID, olanzapine 15 mg QD, placebo BID and Total groups, respectively.
PANSS Marder factor anxiety/depression symptom score   [1] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 97 participants 113 participants 46 participants 101 participants 357 participants
11.0  (2.97) 10.9  (3.13) 10.9  (3.62) 10.7  (2.96) 10.9  (3.09)
[1]
Measure Description: The PANSS is a 30-item scale for assessing the symptoms of schizophrenia. For each PANSS item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS Marder factor anxiety/depression symptom score (calculated from value of 4 identified PANSS items) ranged from 4 to 28 with a higher score indicating greater severity of symptoms. Summary statistics presented are for efficacy population (FAS): N=96, 111, 45, 99 and 351 for asenapine 2.5 mg BID, asenapine 5 mg BID, olanzapine 15 mg QD, placebo BID and Total groups, respectively.
1.Primary Outcome
Title Change From Baseline in PANSS Total Score at Day 42
Hide Description The PANSS is a 30-item clinician-rated instrument for assessing schizophrenia symptoms. It consists of 3 subscales: positive subscale (7 items), negative subscale (7 items), and general psychopathology subscale (16 items). For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS total score for each participant was sum of the rating assigned to each of the 30 PANSS items, and ranged from 30 to 210 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline at Day 42; improvement in symptoms is represented by negative values.
Time Frame Baseline and Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score
Arm/Group Title Asenapine 2.5 mg BID Asenapine 5 mg BID Olanzapine 15 mg QD Placebo BID
Hide Arm/Group Description:
Participants were administered one 2.5 mg asenapine tablet BID for 42 days
Participants were administered one 5 mg asenapine tablet BID for 42 days
Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
Participants were administered placebo tablets BID for 42 days
Overall Number of Participants Analyzed 96 111 45 99
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-17.4  (1.80) -21.7  (1.60) -21.6  (2.32) -16.2  (1.71)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Asenapine 2.5 mg BID, Placebo BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6043
Comments Adjusted p-value from graphical approach to control Type 1 error rate among primary and secondary efficacy hypotheses
Method Mixed Model Repeated Measures (MMRM)
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares (LS) means difference
Estimated Value -1.3
Confidence Interval (2-Sided) 95%
-6.1 to 3.6
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.46
Estimation Comments Asenapine 2.5 mg BID minus Placebo BID
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Asenapine 5 mg BID, Placebo BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0356
Comments Adjusted p-value from graphical approach to control Type 1 error rate among primary and secondary efficacy hypotheses
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value -5.5
Confidence Interval (2-Sided) 95%
-10.1 to -1.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.32
Estimation Comments Asenapine 5 mg BID minus Placebo BID
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Olanzapine 15 mg QD, Placebo BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0587
Comments Unadjusted p-value
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value -5.4
Confidence Interval (2-Sided) 95%
-11.1 to 0.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.86
Estimation Comments Olanzapine 15 mg BID minus Placebo BID
2.Secondary Outcome
Title Change From Baseline in CGI-S Score at Day 42
Hide Description Change from baseline in CGI-S score at Day 42 is a Key Secondary Outcome Measure. CGI-S is a 7-point scale for assessing the global severity of the participant’s illness, with ratings from 1=normal, not ill to 7=very severely ill. The reported measure is the change from baseline at Day 42; improvement in symptoms is represented by negative values.
Time Frame Baseline and Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score
Arm/Group Title Asenapine 2.5 mg BID Asenapine 5 mg BID Olanzapine 15 mg QD Placebo BID
Hide Arm/Group Description:
Participants were administered one 2.5 mg asenapine tablet BID for 42 days
Participants were administered one 5 mg asenapine tablet BID for 42 days
Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
Participants were administered placebo tablets BID for 42 days
Overall Number of Participants Analyzed 96 111 45 99
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-0.9  (0.11) -1.2  (0.10) -1.1  (0.14) -1.0  (0.11)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Asenapine 2.5 mg BID, Placebo BID
Comments Confirmative testing of asenapine versus placebo for this measure was to be performed only if both asenapine doses were statistically superior to placebo in reduction from baseline in PANSS Total Score (Primary outcome measure)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9083
Comments Unadjusted p-value
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-0.3 to 0.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.15
Estimation Comments Asenapine 2.5 mg BID minus Placebo BID
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Asenapine 5 mg BID, Placebo BID
Comments Confirmative testing of asenapine versus placebo for this measure was to be performed only if both asenapine doses were statistically superior to placebo in reduction from baseline in PANSS Total Score (Primary outcome measure)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0601
Comments Unadjusted p-value
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value -0.3
Confidence Interval (2-Sided) 95%
-0.6 to 0.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.14
Estimation Comments Asenapine 5 mg BID minus Placebo BID
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Olanzapine 15 mg QD, Placebo BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3898
Comments Unadjusted p-value
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value -0.2
Confidence Interval (2-Sided) 95%
-0.5 to 0.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.18
Estimation Comments Olanzapine 15 mg BID minus Placebo BID
3.Secondary Outcome
Title Percentage of Participants Who Are PANSS Responders (≥30% Reduction From Baseline in PANSS Total Score) at Day 42
Hide Description Rate of PANSS responders at Day 42 is a Key Secondary Outcome Measure. A PANSS responder was defined as a participant who had a reduction from baseline of at least 30% in the PANSS total score at a post-baseline assessment. The PANSS is a 30-item clinician-rated instrument for assessing schizophrenia symptoms. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The Total score is the sum of the ratings for the individual items, and ranged from 30 to 210 with a higher score indicating greater severity of symptoms. Missing data were imputed by Last Observation Carried Forward (LOCF).
Time Frame Baseline and Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score
Arm/Group Title Asenapine 2.5 mg BID Asenapine 5 mg BID Olanzapine 15 mg QD Placebo BID
Hide Arm/Group Description:
Participants were administered one 2.5 mg asenapine tablet BID for 42 days
Participants were administered one 5 mg asenapine tablet BID for 42 days
Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
Participants were administered placebo tablets BID for 42 days
Overall Number of Participants Analyzed 96 111 45 99
Measure Type: Number
Unit of Measure: percentage of participants
14.6 25.2 26.7 19.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Asenapine 2.5 mg BID, Placebo BID
Comments Confirmative testing of asenapine versus placebo for this measure was to be performed only if both asenapine doses were statistically superior to placebo in reduction from baseline in PANSS Total Score (Primary outcome measure)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3700
Comments P-value from Cochran Mantel-Haenszel test with an adjustment for pooled center
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Asenapine 5 mg BID, Placebo BID
Comments Confirmative testing of asenapine versus placebo for this measure was to be performed only if both asenapine doses were statistically superior to placebo in reduction from baseline in PANSS Total Score (Primary outcome measure)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1708
Comments P-value from Cochran Mantel-Haenszel test with an adjustment for pooled center
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Olanzapine 15 mg QD, Placebo BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2620
Comments P-value from Cochran Mantel-Haenszel test with an adjustment for pooled center
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in Body Weight at Day 42
Hide Description Change from baseline in body weight at Day 42 is the Key Safety Outcome Measure.
Time Frame Baseline and Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received ≥1 dose of study drug
Arm/Group Title Asenapine 2.5 mg BID Asenapine 5 mg BID Olanzapine 15 mg QD Placebo BID
Hide Arm/Group Description:
Participants were administered one 2.5 mg asenapine tablet BID for 42 days
Participants were administered one 5 mg asenapine tablet BID for 42 days
Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
Participants were administered placebo tablets BID for 42 days
Overall Number of Participants Analyzed 97 113 46 101
Least Squares Mean (Standard Error)
Unit of Measure: kg
1.3  (0.38) 1.3  (0.33) 2.4  (0.47) 0.3  (0.35)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Asenapine 2.5 mg BID, Olanzapine 15 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0491
Comments p-value adjusted for multiple comparisons using Hochberg's method
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value -1.2
Confidence Interval (2-Sided) 95%
-2.4 to -0.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.60
Estimation Comments Asenapine 2.5 mg BID minus Olanzapine 15 mg QD
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Asenapine 5 mg BID, Olanzapine 15 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0491
Comments p-value adjusted for multiple comparisons using Hochberg's method
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value -1.2
Confidence Interval (2-Sided) 95%
-2.3 to -0.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.57
Estimation Comments Asenapine 5 mg BID minus Olanzapine 15 mg QD
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Asenapine 2.5 mg BID, Placebo BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0567
Comments Unadjusted p-value
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 1.0
Confidence Interval (2-Sided) 95%
-0.0 to 2.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.51
Estimation Comments Asenapine 2.5 mg BID minus Placebo BID
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Asenapine 5 mg BID, Placebo BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0391
Comments Unadjusted p-value
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 1.0
Confidence Interval (2-Sided) 95%
0.0 to 1.9
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.48
Estimation Comments Asenapine 5 mg BID minus Placebo BID
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Olanzapine 15 mg QD, Placebo BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments Unadjusted p-value
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 2.2
Confidence Interval (2-Sided) 95%
1.0 to 3.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.58
Estimation Comments Olanzapine 15 mg BID minus Placebo BID
5.Secondary Outcome
Title Change From Baseline in PANSS Total Score at Days 4, 7, 14, 21, 28 and 35
Hide Description The PANSS is a 30-item clinician-rated instrument for assessing schizophrenia symptoms. It consists of 3 subscales: positive subscale (7 items), negative subscale (7 items), and general psychopathology subscale (16 items). For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS total score for each participant was sum of the rating assigned to each of the 30 PANSS items, and ranged from 30 to 210 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline; improvement in symptoms is represented by negative values.
Time Frame Baseline and Days 4, 7, 14, 21, 28 and 35
Hide Outcome Measure Data
Hide Analysis Population Description
FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score
Arm/Group Title Asenapine 2.5 mg BID Asenapine 5 mg BID Olanzapine 15 mg QD Placebo BID
Hide Arm/Group Description:
Participants were administered one 2.5 mg asenapine tablet BID for 42 days
Participants were administered one 5 mg asenapine tablet BID for 42 days
Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
Participants were administered placebo tablets BID for 42 days
Overall Number of Participants Analyzed 96 111 45 99
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
Day 4 -4.0  (0.80) -4.9  (0.76) -5.5  (1.15) -4.8  (0.81)
Day 7 -7.2  (1.17) -9.1  (1.09) -9.3  (1.67) -7.1  (1.16)
Day 14 -9.9  (1.31) -12.5  (1.19) -12.4  (1.80) -10.7  (1.28)
Day 21 -12.0  (1.55) -14.8  (1.40) -15.2  (2.09) -13.2  (1.50)
Day 28 -12.3  (1.69) -17.1  (1.49) -17.3  (2.21) -15.5  (1.61)
Day 35 -17.0  (1.66) -19.0  (1.48) -20.3  (2.19) -15.4  (1.58)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Asenapine 2.5 mg BID, Placebo BID
Comments Day 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4849
Comments Unadjusted p-value
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 0.8
Confidence Interval (2-Sided) 95%
-1.4 to 2.9
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.09
Estimation Comments Asenapine 2.5 mg BID minus Placebo BID
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Asenapine 5 mg BID, Placebo BID
Comments Day 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8902
Comments Unadjusted p-value
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-2.2 to 1.9
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.06
Estimation Comments Asenapine 5 mg BID minus Placebo BID
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Olanzapine 15 mg QD, Placebo BID
Comments Day 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5826
Comments Unadjusted p-value
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value -0.8
Confidence Interval (2-Sided) 95%
-3.4 to 1.9
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.36
Estimation Comments Olanzapine 15 mg BID minus Placebo BID
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Asenapine 2.5 mg BID, Placebo BID
Comments Day 7
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9271
Comments Unadjusted p-value
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-3.3 to 3.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.61
Estimation Comments Asenapine 2.5 mg BID minus Placebo BID
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Asenapine 5 mg BID, Placebo BID
Comments Day 7
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1902
Comments Unadjusted p-value
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value -2.0
Confidence Interval (2-Sided) 95%
-5.1 to 1.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.56
Estimation Comments Asenapine 5 mg BID minus Placebo BID
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Olanzapine 15 mg QD, Placebo BID
Comments Day 7
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2710
Comments Unadjusted p-value
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value -2.2
Confidence Interval (2-Sided) 95%
-6.2 to 1.7
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.00
Estimation Comments Olanzapine 15 mg BID minus Placebo BID
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Asenapine 2.5 mg BID, Placebo BID
Comments Day 14
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6773
Comments Unadjusted p-value
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 0.7
Confidence Interval (2-Sided) 95%
-2.8 to 4.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.79
Estimation Comments Asenapine 2.5 mg BID minus Placebo BID
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Asenapine 5 mg BID, Placebo BID
Comments Day 14
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2895
Comments Unadjusted p-value
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value -1.8
Confidence Interval (2-Sided) 95%
-5.2 to 1.6
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.72
Estimation Comments Asenapine 5 mg BID minus Placebo BID
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Olanzapine 15 mg QD, Placebo BID
Comments Day 14
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4261
Comments Unadjusted p-value
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value -1.7
Confidence Interval (2-Sided) 95%
-6.0 to 2.6
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.18
Estimation Comments Olanzapine 15 mg BID minus Placebo BID
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Asenapine 2.5 mg BID, Placebo BID
Comments Day 21
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5505
Comments Unadjusted p-value
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 1.3
Confidence Interval (2-Sided) 95%
-2.9 to 5.5
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.13
Estimation Comments Asenapine 2.5 mg BID minus Placebo BID
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Asenapine 5 mg BID, Placebo BID
Comments Day 21
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4286
Comments Unadjusted p-value
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value -1.6
Confidence Interval (2-Sided) 95%
-5.6 to 2.4
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.03
Estimation Comments Asenapine 5 mg BID minus Placebo BID
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Olanzapine 15 mg QD, Placebo BID
Comments Day 21
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4423
Comments Unadjusted p-value
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value -2.0
Confidence Interval (2-Sided) 95%
-7.0 to 3.1
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.56
Estimation Comments Olanzapine 15 mg BID minus Placebo BID
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Asenapine 2.5 mg BID, Placebo BID
Comments Day 28
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1691
Comments Unadjusted p-value
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 3.2
Confidence Interval (2-Sided) 95%
-1.4 to 7.7
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.30
Estimation Comments Asenapine 2.5 mg BID minus Placebo BID
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Asenapine 5 mg BID, Placebo BID
Comments Day 28
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4682
Comments Unadjusted p-value
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value -1.6
Confidence Interval (2-Sided) 95%
-5.8 to 2.7
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.17
Estimation Comments Asenapine 5 mg BID minus Placebo BID
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Olanzapine 15 mg QD, Placebo BID
Comments Day 28
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4961
Comments Unadjusted p-value
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value -1.8
Confidence Interval (2-Sided) 95%
-7.2 to 3.5
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.71
Estimation Comments Olanzapine 15 mg BID minus Placebo BID
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Asenapine 2.5 mg BID, Placebo BID
Comments Day 35
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4697
Comments Unadjusted p-value
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value -1.6
Confidence Interval (2-Sided) 95%
-6.1 to 2.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.26
Estimation Comments Asenapine 2.5 mg BID minus Placebo BID
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Asenapine 5 mg BID, Placebo BID
Comments Day 35
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0947
Comments Unadjusted p-value
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value -3.6
Confidence Interval (2-Sided) 95%
-7.8 to 0.6
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.14
Estimation Comments Asenapine 5 mg BID minus Placebo BID
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Olanzapine 15 mg QD, Placebo BID
Comments Day 35
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0675
Comments Unadjusted p-value
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value -4.9
Confidence Interval (2-Sided) 95%
-10.2 to 0.4
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.68
Estimation Comments Olanzapine 15 mg BID minus Placebo BID
6.Secondary Outcome
Title Percentage of Participants Who Are PANSS Responders (≥30% Reduction From Baseline in PANSS Total Score) at Days 4, 7, 14, 21, 28 and 35
Hide Description A PANSS responder was defined as a participant who had a reduction from baseline of at least 30% in the PANSS total score at a post-baseline assessment. The PANSS is a 30-item clinician-rated instrument for assessing schizophrenia symptoms. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The Total score is the sum of the ratings for the individual items, and ranged from 30 to 210 with a higher score indicating greater severity of symptoms. Missing data were imputed by LOCF.
Time Frame Days 4, 7, 14, 21, 28 and 35
Hide Outcome Measure Data
Hide Analysis Population Description
FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score
Arm/Group Title Asenapine 2.5 mg BID Asenapine 5 mg BID Olanzapine 15 mg QD Placebo BID
Hide Arm/Group Description:
Participants were administered one 2.5 mg asenapine tablet BID for 42 days
Participants were administered one 5 mg asenapine tablet BID for 42 days
Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
Participants were administered placebo tablets BID for 42 days
Overall Number of Participants Analyzed 96 111 45 99
Measure Type: Number
Unit of Measure: percentage of participants
Day 4 (n = 95,108,44,97) 0.0 0.0 0.0 2.1
Day 7 (n = 96,111,45,99) 2.1 5.4 0.0 5.1
Day 14 (n = 96,111,45,99) 5.2 5.4 4.4 7.1
Day 21 (n = 96,111,45,99) 8.3 14.4 11.1 13.1
Day 28 (n = 96,111,45,99) 10.4 16.2 15.6 14.1
Day 35 (n = 96,111,45,99) 15.6 21.6 15.6 17.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Asenapine 2.5 mg BID, Placebo BID
Comments Day 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1736
Comments P-value from Cochran Mantel-Haenszel test with an adjustment for pooled center
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Asenapine 5 mg BID, Placebo BID
Comments Day 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1736
Comments P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Olanzapine 15 mg QD, Placebo BID
Comments Day 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2850
Comments P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Asenapine 2.5 mg BID, Placebo BID
Comments Day 7
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3290
Comments P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Asenapine 5 mg BID, Placebo BID
Comments Day 7
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6938
Comments P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Olanzapine 15 mg QD, Placebo BID
Comments Day 7
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1105
Comments P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Asenapine 2.5 mg BID, Placebo BID
Comments Day 14
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6804
Comments P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Asenapine 5 mg BID, Placebo BID
Comments Day 14
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9704
Comments P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Olanzapine 15 mg QD, Placebo BID
Comments Day 14
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6604
Comments P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Asenapine 2.5 mg BID, Placebo BID
Comments Day 21
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2447
Comments P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Asenapine 5 mg BID, Placebo BID
Comments Day 21
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4834
Comments P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Olanzapine 15 mg QD, Placebo BID
Comments Day 21
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9189
Comments P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Asenapine 2.5 mg BID, Placebo BID
Comments Day 28
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4370
Comments P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Asenapine 5 mg BID, Placebo BID
Comments Day 28
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2894
Comments P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Olanzapine 15 mg QD, Placebo BID
Comments Day 28
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6953
Comments P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Asenapine 2.5 mg BID, Placebo BID
Comments Day 35
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4892
Comments P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Asenapine 5 mg BID, Placebo BID
Comments Day 35
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1954
Comments P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Olanzapine 15 mg QD, Placebo BID
Comments Day 35
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7990
Comments P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline in CGI-S Score at Days 4, 7, 14, 21, 28 and 35
Hide Description CGI-S is a 7-point scale for assessing the global severity of the participant’s illness, with ratings from 1=normal, not ill to 7=very severely ill. The reported measure is the change from baseline; improvement in symptoms is represented by negative values.
Time Frame Baseline and Days 4, 7, 14, 21, 28 and 35
Hide Outcome Measure Data
Hide Analysis Population Description
FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score
Arm/Group Title Asenapine 2.5 mg BID Asenapine 5 mg BID Olanzapine 15 mg QD Placebo BID
Hide Arm/Group Description:
Participants were administered one 2.5 mg asenapine tablet BID for 42 days
Participants were administered one 5 mg asenapine tablet BID for 42 days
Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
Participants were administered placebo tablets BID for 42 days
Overall Number of Participants Analyzed 96 111 45 99
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
Day 4 -0.1  (0.05) -0.2  (0.05) -0.2  (0.07) -0.2  (0.05)
Day 7 -0.3  (0.07) -0.3  (0.06) -0.3  (0.10) -0.3  (0.07)
Day 14 -0.6  (0.08) -0.6  (0.07) -0.6  (0.11) -0.5  (0.08)
Day 21 -0.6  (0.10) -0.8  (0.09) -0.8  (0.13) -0.7  (0.09)
Day 28 -0.7  (0.11) -0.9  (0.09) -0.8  (0.14) -0.8  (0.10)
Day 35 -0.9  (0.11) -1.1  (0.10) -1.0  (0.14) -0.8  (0.10)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Asenapine 2.5 mg BID, Placebo BID
Comments Day 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4255
Comments Unadjusted p-value
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 0.1
Confidence Interval (2-Sided) 95%
-0.1 to 0.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.07
Estimation Comments Asenapine 2.5 mg BID minus Placebo BID
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Asenapine 5 mg BID, Placebo BID
Comments Day 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9564
Comments Unadjusted p-value
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value -0.0
Confidence Interval (2-Sided) 95%
-0.1 to 0.1
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.06
Estimation Comments Asenapine 5 mg BID minus Placebo BID
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Olanzapine 15 mg QD, Placebo BID
Comments Day 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6363
Comments Unadjusted p-value
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value -0.0
Confidence Interval (2-Sided) 95%
-0.2 to 0.1
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.08
Estimation Comments Olanzapine 15 mg BID minus Placebo BID
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Asenapine 2.5 mg BID, Placebo BID
Comments Day 7
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8759
Comments Unadjusted p-value
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value -0.0
Confidence Interval (2-Sided) 95%
-0.2 to 0.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.10
Estimation Comments Asenapine 2.5 mg BID minus Placebo BID
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Asenapine 5 mg BID, Placebo BID
Comments Day 7
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9598
Comments Unadjusted p-value
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-0.2 to 0.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.09
Estimation Comments Asenapine 5 mg BID minus Placebo BID
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Olanzapine 15 mg QD, Placebo BID
Comments Day 7
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9789
Comments Unadjusted p-value
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value -0.0
Confidence Interval (2-Sided) 95%
-0.2 to 0.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.12
Estimation Comments Olanzapine 15 mg BID minus Placebo BID
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Asenapine 2.5 mg BID, Placebo BID
Comments Day 14
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4671
Comments Unadjusted p-value
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-0.3 to 0.1
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.11
Estimation Comments Asenapine 2.5 mg BID minus Placebo BID
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Asenapine 5 mg BID, Placebo BID
Comments Day 14
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6359
Comments Unadjusted p-value
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-0.3 to 0.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.11
Estimation Comments Asenapine 5 mg BID minus Placebo BID
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Olanzapine 15 mg QD, Placebo BID
Comments Day 14
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5454
Comments Unadjusted p-value
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-0.4 to 0.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.14
Estimation Comments Olanzapine 15 mg BID minus Placebo BID
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Asenapine 2.5 mg BID, Placebo BID
Comments Day 21
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4188
Comments Unadjusted p-value
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 0.1
Confidence Interval (2-Sided) 95%
-0.2 to 0.4
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.13
Estimation Comments Asenapine 2.5 mg BID minus Placebo BID
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Asenapine 5 mg BID, Placebo BID
Comments Day 21
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5318
Comments Unadjusted p-value
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-0.3 to 0.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.13
Estimation Comments Asenapine 5 mg BID minus Placebo BID
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Olanzapine 15 mg QD, Placebo BID
Comments Day 21
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5683
Comments Unadjusted p-value
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-0.4 to 0.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.16
Estimation Comments Olanzapine 15 mg BID minus Placebo BID
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Asenapine 2.5 mg BID, Placebo BID
Comments Day 28
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2972
Comments Unadjusted p-value
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 0.2
Confidence Interval (2-Sided) 95%
-0.1 to 0.4
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.14
Estimation Comments Asenapine 2.5 mg BID minus Placebo BID
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Asenapine 5 mg BID, Placebo BID
Comments Day 28
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4820
Comments Unadjusted p-value
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-0.4 to 0.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.13
Estimation Comments Asenapine 5 mg BID minus Placebo BID
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Olanzapine 15 mg QD, Placebo BID
Comments Day 28
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9901
Comments Unadjusted p-value
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value -0.0
Confidence Interval (2-Sided) 95%
-0.3 to 0.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.17
Estimation Comments Olanzapine 15 mg BID minus Placebo BID
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Asenapine 2.5 mg BID, Placebo BID
Comments Day 35
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6682
Comments Unadjusted p-value
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-0.4 to 0.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.15
Estimation Comments Asenapine 2.5 mg BID minus Placebo BID
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Asenapine 5 mg BID, Placebo BID
Comments Day 35
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1111
Comments Unadjusted p-value
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value -0.2
Confidence Interval (2-Sided) 95%
-0.5 to 0.1
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.14
Estimation Comments Asenapine 5 mg BID minus Placebo BID
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Olanzapine 15 mg QD, Placebo BID
Comments Day 35
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2400
Comments Unadjusted p-value
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value -0.2
Confidence Interval (2-Sided) 95%
-0.5 to 0.1
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.17
Estimation Comments Olanzapine 15 mg BID minus Placebo BID
8.Secondary Outcome
Title Percentage of Participants Who Are Clinical Global Impression Scale-Improvement (CGI-I) Responders at Days 4, 7, 14, 21, 28, 35 and 42
Hide Description A CGI-I responder was defined as a participant who had a CGI-I score of 1 (very much improved) or 2 (much improved) at a post-baseline assessment. CGI-I is a 7-point scale for assessing the global improvement of the participant’s illness relative to baseline, with ratings from 1=very much improved to 7=very much worse. Missing data were imputed by LOCF.
Time Frame Days 4, 7, 14, 21, 28, 35 and 42
Hide Outcome Measure Data
Hide Analysis Population Description
FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score
Arm/Group Title Asenapine 2.5 mg BID Asenapine 5 mg BID Olanzapine 15 mg QD Placebo BID
Hide Arm/Group Description:
Participants were administered one 2.5 mg asenapine tablet BID for 42 days
Participants were administered one 5 mg asenapine tablet BID for 42 days
Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
Participants were administered placebo tablets BID for 42 days
Overall Number of Participants Analyzed 96 111 45 99
Measure Type: Number
Unit of Measure: percentage of participants
Day 4 (n = 95,108,44,98) 34.7 33.3 43.2 37.8
Day 7 (n = 96,111,45,99) 51.0 46.8 60.0 45.5
Day 14 (n = 96,111,45,99) 51.0 60.4 71.1 54.5
Day 21 (n = 96,111,45,99) 54.2 63.1 75.6 58.6
Day 28 (n = 96,111,45,99) 58.3 62.2 73.3 60.6
Day 35 (n = 96,111,45,99) 60.4 64.0 82.2 64.6
Day 42 (n = 96,111,45,99) 59.4 66.7 84.4 62.6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Asenapine 2.5 mg BID, Placebo BID
Comments Day 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6205
Comments P-value from Cochran Mantel-Haenszel test with an adjustment for pooled center
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Asenapine 5 mg BID, Placebo BID
Comments Day 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4829
Comments P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Olanzapine 15 mg QD, Placebo BID
Comments Day 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3945
Comments P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Asenapine 2.5 mg BID, Placebo BID
Comments Day 7
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4076
Comments P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Asenapine 5 mg BID, Placebo BID
Comments Day 7
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9690
Comments P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Olanzapine 15 mg QD, Placebo BID
Comments Day 7
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1170
Comments P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Asenapine 2.5 mg BID, Placebo BID
Comments Day 14
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5088
Comments P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Asenapine 5 mg BID, Placebo BID
Comments Day 14
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3426
Comments P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Olanzapine 15 mg QD, Placebo BID
Comments Day 14
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0762
Comments P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Asenapine 2.5 mg BID, Placebo BID
Comments Day 21
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5531
Comments P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Asenapine 5 mg BID, Placebo BID
Comments Day 21
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4875
Comments P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Olanzapine 15 mg QD, Placebo BID
Comments Day 21
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0692
Comments P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Asenapine 2.5 mg BID, Placebo BID
Comments Day 28
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7482
Comments P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Asenapine 5 mg BID, Placebo BID
Comments Day 28
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8037
Comments P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Olanzapine 15 mg QD, Placebo BID
Comments Day 28
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0859
Comments P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Asenapine 2.5 mg BID, Placebo BID
Comments Day 35
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5850
Comments P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Asenapine 5 mg BID, Placebo BID
Comments Day 35
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9698
Comments P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Olanzapine 15 mg QD, Placebo BID
Comments Day 35
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0132
Comments P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 19 Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Asenapine 2.5 mg BID, Placebo BID
Comments Day 42
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7129
Comments P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 20 Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Asenapine 5 mg BID, Placebo BID
Comments Day 42
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5074
Comments P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 21 Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Olanzapine 15 mg QD, Placebo BID
Comments Day 42
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0040
Comments P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
9.Secondary Outcome
Title Change From Baseline in PANSS Negative Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42
Hide Description This measure reports results for the 7 items of the negative subscale of the PANSS, which is a 30-item clinician-rated instrument used to assess schizophrenia symptoms. Negative symptoms represent a diminution or loss of normal functions (e.g., emotional withdrawal). For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. PANSS negative subscale score for each participant was sum of the rating assigned to each of the 7 subscale items, and ranged from 7 to 49 with a higher score indicating greater severity of symptoms. Measure reports change from baseline; improvement in symptoms is represented by negative values.
Time Frame Baseline and Days 4, 7, 14, 21, 28, 35 and 42
Hide Outcome Measure Data
Hide Analysis Population Description
FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score
Arm/Group Title Asenapine 2.5 mg BID Asenapine 5 mg BID Olanzapine 15 mg QD Placebo BID
Hide Arm/Group Description:
Participants were administered one 2.5 mg asenapine tablet BID for 42 days
Participants were administered one 5 mg asenapine tablet BID for 42 days
Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
Participants were administered placebo tablets BID for 42 days
Overall Number of Participants Analyzed 96 111 45 99
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
Day 4 -0.7  (0.29) -0.5  (0.27) -0.9  (0.42) -0.8  (0.29)
Day 7 -1.2  (0.33) -1.3  (0.31) -1.5  (0.47) -1.1  (0.33)
Day 14 -1.6  (0.37) -2.3  (0.34) -1.7  (0.51) -1.8  (0.37)
Day 21 -2.3  (0.41) -2.5  (0.37) -2.0  (0.56) -2.3  (0.40)
Day 28 -2.5  (0.45) -3.1  (0.40) -2.6  (0.59) -3.0  (0.43)
Day 35 -3.3  (0.48) -3.4  (0.43) -3.4  (0.63) -2.6  (0.46)
Day 42 -3.3  (0.54) -4.3  (0.48) -3.8  (0.68) -3.2  (0.51)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Asenapine 2.5 mg BID, Placebo BID
Comments Day 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8829
Comments Unadjusted p-value
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 0.1
Confidence Interval (2-Sided) 95%
-0.7 to 0.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.40
Estimation Comments Asenapine 2.5 mg BID minus Placebo BID
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Asenapine 5 mg BID, Placebo BID
Comments Day 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5488
Comments Unadjusted p-value
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 0.2
Confidence Interval (2-Sided) 95%
-0.5 to 1.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.39
Estimation Comments Asenapine 5 mg BID minus Placebo BID
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Olanzapine 15 mg QD, Placebo BID
Comments Day 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7830
Comments Unadjusted p-value
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-1.1 to 0.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.50
Estimation Comments Olanzapine 15 mg BID minus Placebo BID
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Asenapine 2.5 mg BID, Placebo BID
Comments Day 7
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8070
Comments Unadjusted p-value
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-1.0 to 0.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.45
Estimation Comments Asenapine 2.5 mg BID minus Placebo BID
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Asenapine 5 mg BID, Placebo BID
Comments Day 7
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5280
Comments Unadjusted p-value
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value -0.3
Confidence Interval (2-Sided) 95%
-1.1 to 0.6
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.44
Estimation Comments Asenapine 5 mg BID minus Placebo BID
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Olanzapine 15 mg QD, Placebo BID
Comments Day 7
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4025
Comments Unadjusted p-value
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value -0.5
Confidence Interval (2-Sided) 95%
-1.6 to 0.6
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.57
Estimation Comments Olanzapine 15 mg BID minus Placebo BID
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Asenapine 2.5 mg BID, Placebo BID
Comments Day 14
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6471
Comments Unadjusted p-value
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 0.2
Confidence Interval (2-Sided) 95%
-0.8 to 1.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.51
Estimation Comments Asenapine 2.5 mg BID minus Placebo BID
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Asenapine 5 mg BID, Placebo BID
Comments Day 14
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2504
Comments Unadjusted p-value
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value -0.6
Confidence Interval (2-Sided) 95%
-1.5 to 0.4
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.49
Estimation Comments Asenapine 5 mg BID minus Placebo BID
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Olanzapine 15 mg QD, Placebo BID
Comments Day 14
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9223
Comments Unadjusted p-value
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 0.1
Confidence Interval (2-Sided) 95%
-1.2 to 1.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.62
Estimation Comments Olanzapine 15 mg BID minus Placebo BID
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Asenapine 2.5 mg BID, Placebo BID
Comments Day 21
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8839
Comments Unadjusted p-value
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 0.1
Confidence Interval (2-Sided) 95%
-1.0 to 1.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.56
Estimation Comments Asenapine 2.5 mg BID minus Placebo BID
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Asenapine 5 mg BID, Placebo BID
Comments Day 21
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8077
Comments Unadjusted p-value
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-1.2 to 0.9
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.54
Estimation Comments Asenapine 5 mg BID minus Placebo BID
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Olanzapine 15 mg QD, Placebo BID
Comments Day 21
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6216
Comments Unadjusted p-value
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 0.3
Confidence Interval (2-Sided) 95%
-1.0 to 1.7
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.68
Estimation Comments Olanzapine 15 mg BID minus Placebo BID
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Asenapine 2.5 mg BID, Placebo BID
Comments Day 28
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4248
Comments Unadjusted p-value
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 0.5
Confidence Interval (2-Sided) 95%
-0.7 to 1.7
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.61
Estimation Comments Asenapine 2.5 mg BID minus Placebo BID
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Asenapine 5 mg BID, Placebo BID
Comments Day 28
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7667
Comments Unadjusted p-value
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value -0.2
Confidence Interval (2-Sided) 95%
-1.3 to 1.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.58
Estimation Comments Asenapine 5 mg BID minus Placebo BID
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Olanzapine 15 mg QD, Placebo BID
Comments Day 28
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6282
Comments Unadjusted p-value
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 0.4
Confidence Interval (2-Sided) 95%
-1.1 to 1.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.72
Estimation Comments Olanzapine 15 mg BID minus Placebo BID
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Asenapine 2.5 mg BID, Placebo BID
Comments Day 35
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3150
Comments Unadjusted p-value
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value -0.7
Confidence Interval (2-Sided) 95%
-1.9 to 0.6
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.65
Estimation Comments Asenapine 2.5 mg BID minus Placebo BID
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Asenapine 5 mg BID, Placebo BID
Comments Day 35
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1908
Comments Unadjusted p-value
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value -0.8
Confidence Interval (2-Sided) 95%
-2.0 to 0.4
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.61
Estimation Comments Asenapine 5 mg BID minus Placebo BID
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Olanzapine 15 mg QD, Placebo BID
Comments Day 35
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3128
Comments Unadjusted p-value
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value -0.8
Confidence Interval (2-Sided) 95%
-2.3 to 0.7
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.77
Estimation Comments Olanzapine 15 mg BID minus Placebo BID
Show Statistical Analysis 19 Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Asenapine 2.5 mg BID, Placebo BID
Comments Day 42
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8812
Comments Unadjusted p-value
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-1.5 to 1.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.73
Estimation Comments Asenapine 2.5 mg BID minus Placebo BID
Show Statistical Analysis 20 Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Asenapine 5 mg BID, Placebo BID
Comments Day 42
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1143
Comments Unadjusted p-value
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value -1.1
Confidence Interval (2-Sided) 95%
-2.4 to 0.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.69
Estimation Comments Asenapine 5 mg BID minus Placebo BID
Show Statistical Analysis 21 Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Olanzapine 15 mg QD, Placebo BID
Comments Day 42
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4418
Comments Unadjusted p-value
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value -0.6
Confidence Interval (2-Sided) 95%
-2.3 to 1.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.84
Estimation Comments Olanzapine 15 mg BID minus Placebo BID
10.Secondary Outcome
Title Change From Baseline in PANSS Positive Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42
Hide Description This measure reports results for the 7 items of the positive subscale of the PANSS, which is a 30-item clinician-rated instrument used to assess schizophrenia symptoms. Positive symptoms refer to an excess or distortion of normal mental status (e.g., delusions). For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. PANSS positive subscale score for each participant was sum of the rating assigned to each of the 7 subscale items, and ranged from 7 to 49 with a higher score indicating greater severity of symptoms. Measure reports change from baseline; improvement in symptoms is represented by negative values.
Time Frame Baseline and Days 4, 7, 14, 21, 28, 35 and 42
Hide Outcome Measure Data
Hide Analysis Population Description
FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score
Arm/Group Title Asenapine 2.5 mg BID Asenapine 5 mg BID Olanzapine 15 mg QD Placebo BID
Hide Arm/Group Description:
Participants were administered one 2.5 mg asenapine tablet BID for 42 days
Participants were administered one 5 mg asenapine tablet BID for 42 days
Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
Participants were administered placebo tablets BID for 42 days
Overall Number of Participants Analyzed 96 111 45 99
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
Day 4 -1.2  (0.29) -1.6  (0.28) -2.3  (0.42) -1.7  (0.30)
Day 7 -2.3  (0.39) -2.8  (0.36) -3.6  (0.55) -2.6  (0.38)
Day 14 -3.4  (0.45) -3.9  (0.40) -4.4  (0.61) -3.7  (0.43)
Day 21 -4.0  (0.52) -5.0  (0.47) -5.7  (0.70) -4.5  (0.51)
Day 28 -4.1  (0.59) -5.7  (0.52) -6.2  (0.77) -5.0  (0.56)
Day 35 -5.2  (0.60) -6.3  (0.53) -6.8  (0.78) -5.5  (0.57)
Day 42 -5.6  (0.65) -7.2  (0.57) -7.5  (0.83) -5.4  (0.61)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Asenapine 2.5 mg BID, Placebo BID
Comments Day 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2160
Comments Unadjusted p-value
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 0.5
Confidence Interval (2-Sided) 95%
-0.3 to 1.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.40
Estimation Comments Asenapine 2.5 mg BID minus Placebo BID
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Asenapine 5 mg BID, Placebo BID
Comments Day 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9494
Comments Unadjusted p-value
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-0.7 to 0.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.39
Estimation Comments Asenapine 5 mg BID minus Placebo BID
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Olanzapine 15 mg QD, Placebo BID
Comments Day 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1834
Comments Unadjusted p-value
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value -0.7
Confidence Interval (2-Sided) 95%
-1.6 to 0.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.50
Estimation Comments Olanzapine 15 mg BID minus Placebo BID
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Asenapine 2.5 mg BID, Placebo BID
Comments Day 7
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6347
Comments Unadjusted p-value
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 0.3
Confidence Interval (2-Sided) 95%
-0.8 to 1.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.53
Estimation Comments Asenapine 2.5 mg BID minus Placebo BID
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Asenapine 5 mg BID, Placebo BID
Comments Day 7
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6917
Comments Unadjusted p-value
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value -0.2
Confidence Interval (2-Sided) 95%
-1.2 to 0.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.51
Estimation Comments Asenapine 5 mg BID minus Placebo BID
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Olanzapine 15 mg QD, Placebo BID
Comments Day 7
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1431
Comments Unadjusted p-value
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value -1.0
Confidence Interval (2-Sided) 95%
-2.3 to 0.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.66
Estimation Comments Olanzapine 15 mg BID minus Placebo BID
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Asenapine 2.5 mg BID, Placebo BID
Comments Day 14
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6267
Comments Unadjusted p-value
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 0.3
Confidence Interval (2-Sided) 95%
-0.9 to 1.5
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.61
Estimation Comments Asenapine 2.5 mg BID minus Placebo BID
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Asenapine 5 mg BID, Placebo BID
Comments Day 14
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7260
Comments Unadjusted p-value
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value -0.2
Confidence Interval (2-Sided) 95%
-1.3 to 0.9
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.58
Estimation Comments Asenapine 5 mg BID minus Placebo BID
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Olanzapine 15 mg QD, Placebo BID
Comments Day 14
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3326
Comments Unadjusted p-value
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value -0.7
Confidence Interval (2-Sided) 95%
-2.2 to 0.7
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.74
Estimation Comments Olanzapine 15 mg BID minus Placebo BID
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Asenapine 2.5 mg BID, Placebo BID
Comments Day 21
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4575
Comments Unadjusted p-value
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS means difference
Estimated Value 0.5
Confidence Interval (2-Sided) 95%
-0.9 to 1.9
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.72
Estimation Comments Asenapine 2.5 mg BID minus Placebo BID
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Asenapine 5 mg BID, Placebo BID
Comments Day 21
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis