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Trial record 74 of 405 for:    ARIPIPRAZOLE

Trial of Aripiprazole Intramuscular Depot (OPC-14597, Lu AF41155) in the Acute Treatment of Adults With Schizophrenia

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ClinicalTrials.gov Identifier: NCT01663532
Recruitment Status : Completed
First Posted : August 13, 2012
Results First Posted : February 16, 2015
Last Update Posted : February 16, 2015
Sponsor:
Collaborators:
H. Lundbeck A/S
Otsuka America Pharmaceutical
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Schizophrenia
Interventions Drug: Aripiprazole IM Depot
Drug: Placebo
Enrollment 340
Recruitment Details The trial was a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of aripiprazole IM (intramuscular) depot as treatment for an acute episode of schizophrenia in adult participants. The trial was conducted in 55 sites.
Pre-assignment Details This trial included a 13-Day Screening phase (which includes Washout from previous antipsychotics for 7 days and/or washout from other prohibited medications), a 12-Week acute treatment phase, and a 14 (±2) Day safety follow-up.
Arm/Group Title Aripiprazole IM Depot 400/300mg Placebo
Hide Arm/Group Description Participants randomized to aripiprazole IM depot received aripiprazole IM depot 400 mg as the initial dose with a single decrease to aripiprazole IM depot 300 mg permitted for tolerability per the study physician. The study treatment was injected into gluteal muscle every 4 weeks (Baseline/Day, Week 4, Week 8) during the 12-Week Acute Treatment Phase (ie, 3 IM depot injections). For 14 days beginning with the first injection, participants received concomitant oral aripiprazole (10 to 20 mg/day based on the study physician's clinical judgment). Participants randomized to Placebo group received matching placebo. For 14 days beginning with the first injection, participants received concomitant oral placebo.
Period Title: Overall Study
Started 168 172
Completed 94 65
Not Completed 74 107
Reason Not Completed
Lost to Follow-up             9             10
Adverse Event             7             13
Met Withdrawal Criteria             7             6
Physician Decision             1             1
Withdrawal by Subject             35             17
Lack of Efficacy             15             60
Arm/Group Title Aripiprazole IM Depot 400/300mg Placebo Total
Hide Arm/Group Description Participants randomized to aripiprazole IM depot received aripiprazole IM depot 400 mg as the initial dose with a single decrease to aripiprazole IM depot 300 mg permitted for tolerability per the study physician. The study treatment was injected into gluteal muscle every 4 weeks (Baseline/Day, Week 4, Week 8) during the 12-Week Acute Treatment Phase (ie, 3 IM depot injections). For 14 days beginning with the first injection, participants received concomitant oral aripiprazole (10 to 20 mg/day based on the study physician's clinical judgment). Participants randomized to Placebo group received matching placebo. For 14 days beginning with the first injection, participants received concomitant oral placebo. Total of all reporting groups
Overall Number of Baseline Participants 168 172 340
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 168 participants 172 participants 340 participants
42.1  (11.0) 42.7  (10.9) 42.4  (11.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 168 participants 172 participants 340 participants
Female
38
  22.6%
33
  19.2%
71
  20.9%
Male
130
  77.4%
139
  80.8%
269
  79.1%
1.Primary Outcome
Title Mean Change From Baseline to Endpoint in Positive and Negative Syndrome Scale (PANSS) Total Score.
Hide Description The PANSS consisted of three subscales that contained a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 that indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. The PANSS total score was the sum of the rating scores for 7 positive subscale items, 7 negative subscale items, and 16 general psychopathology subscale items from the PANSS panel. PANSS Total Score ranged from 30 (best possible outcome) to 210 (worst possible outcome). The primary statistical comparison was performed using the Mixed Model Repeated Measure (MMRM) approach.
Time Frame Baseline to Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy sample was defined as the intent to treat (ITT) population which included randomized participants who took at least one injection of double-blind (aripiprazole IM depot or placebo) and had at least one Post-Baseline efficacy assessment. Data of only 162 and 167 participants from aripiprazole and placebo groups were available.
Arm/Group Title Aripiprazole IM Depot 400/300mg Placebo
Hide Arm/Group Description:
Participants randomized to aripiprazole IM depot received aripiprazole IM depot 400 mg as the initial dose with a single decrease to aripiprazole IM depot 300 mg permitted for tolerability per the study physician. The study treatment was injected into gluteal muscle every 4 weeks (Baseline/Day, Week 4, Week 8) during the 12-Week Acute Treatment Phase (ie, 3 IM depot injections). For 14 days beginning with the first injection, participants received concomitant oral aripiprazole (10 to 20 mg/day based on the study physician's clinical judgment).
Participants randomized to Placebo group received matching placebo. For 14 days beginning with the first injection, participants received concomitant oral placebo.
Overall Number of Participants Analyzed 162 167
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Week 1 (N= 162, 167) -8.9  (0.9) -5.0  (0.9)
Week 2 (N= 144, 157) -15.2  (1.2) -8.3  (1.2)
Week 4 (N= 134, 140) -19.0  (1.4) -9.8  (1.3)
Week 6 (N= 126, 117) -21.5  (1.5) -10.3  (1.5)
Week 8 (N= 108, 96) -23.7  (1.6) -9.7  (1.6)
Week 10 (N= 99, 81) -26.8  (1.6) -11.7  (1.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aripiprazole IM Depot 400/300mg, Placebo
Comments Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested. The sample size estimated a 1:1 randomization ratio (aripiprazole IM depot 400/300mg: placebo) to achieve 90% power and to preserve a nominal alpha level of 0.05 given a treatment difference of -7.5 points in change from Baseline with standard deviation of 20 points between aripiprazole and placebo using a two-sided z-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0005
Comments Kenward-Rodger degree of freedom was used to test the treatment effects and p-value was not adjusted as this is a primary efficacy endpoint.
Method Mixed Models Analysis
Comments MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.9
Confidence Interval (2-Sided) 95%
-6.1 to -1.7
Estimation Comments Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 1.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Aripiprazole IM Depot 400/300mg, Placebo
Comments Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested. The sample size estimated a 1:1 randomization ratio (aripiprazole IM depot 400/300mg: placebo) to achieve 90% power and to preserve a nominal alpha level of 0.05 given a treatment difference of -7.5 points in change from Baseline with standard deviation of 20 points between aripiprazole and placebo using a two-sided z-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments Kenward-Rodger degree of freedom was used to test the treatment effects and p-value was not adjusted as this is a primary efficacy endpoint.
Method Mixed Models Analysis
Comments MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -7.0
Confidence Interval (2-Sided) 95%
-10.0 to -4.0
Estimation Comments Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 2.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Aripiprazole IM Depot 400/300mg, Placebo
Comments Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested. The sample size estimated a 1:1 randomization ratio (aripiprazole IM depot 400/300mg: placebo) to achieve 90% power and to preserve a nominal alpha level of 0.05 given a treatment difference of -7.5 points in change from Baseline with standard deviation of 20 points between aripiprazole and placebo using a two-sided z-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments Kenward-Rodger degree of freedom was used to test the treatment effects and p-value was not adjusted as this is a primary efficacy endpoint.
Method Mixed Models Analysis
Comments MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -9.2
Confidence Interval (2-Sided) 95%
-12.8 to -5.6
Estimation Comments Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at week 4.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Aripiprazole IM Depot 400/300mg, Placebo
Comments Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested. The sample size estimated a 1:1 randomization ratio (aripiprazole IM depot 400/300mg: placebo) to achieve 90% power and to preserve a nominal alpha level of 0.05 given a treatment difference of -7.5 points in change from Baseline with standard deviation of 20 points between aripiprazole and placebo using a two-sided z-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments Kenward-Rodger degree of freedom was used to test the treatment effects and p-value was not adjusted as this is a primary efficacy endpoint.
Method Mixed Models Analysis
Comments MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -11.1
Confidence Interval (2-Sided) 95%
-15.0 to -7.3
Estimation Comments Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 6.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Aripiprazole IM Depot 400/300mg, Placebo
Comments Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested. The sample size estimated a 1:1 randomization ratio (aripiprazole IM depot 400/300mg: placebo) to achieve 90% power and to preserve a nominal alpha level of 0.05 given a treatment difference of -7.5 points in change from Baseline with standard deviation of 20 points between aripiprazole and placebo using a two-sided z-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments Kenward-Rodger degree of freedom was used to test the treatment effects and p-value was not adjusted as this is a primary efficacy endpoint.
Method Mixed Models Analysis
Comments MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -14.0
Confidence Interval (2-Sided) 95%
-18.4 to -9.6
Estimation Comments Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 8.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Aripiprazole IM Depot 400/300mg, Placebo
Comments Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested. The sample size estimated a 1:1 randomization ratio (aripiprazole IM depot 400/300mg: placebo) to achieve 90% power and to preserve a nominal alpha level of 0.05 given a treatment difference of -7.5 points in change from Baseline with standard deviation of 20 points between aripiprazole and placebo using a two-sided z-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments Kenward-Rodger degree of freedom was used to test the treatment effects and p-value was not adjusted as this is a primary efficacy endpoint.
Method Mixed Models Analysis
Comments MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -15.1
Confidence Interval (2-Sided) 95%
-19.4 to -10.8
Estimation Comments Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 10.
2.Secondary Outcome
Title Mean Change From Baseline to Endpoint in Clinical Global Impression-Severity Scale (CGI-S) Score.
Hide Description The severity of illness for each participants were rated using the CGI-S scale. The study physician were to answer the following question: "Considering your total experience with this particular population, how mentally ill is the patient at this time?" Response choices included were: 0= not assessed; 1= normal; not at all ill; 2= borderline mentally ill; 3= mildly ill; 4= moderately ill; 5= markedly ill; 6= severely ill; and 7= among the most extremely ill participants.
Time Frame Baseline to Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy sample was defined as the intent to treat (ITT) population which included randomized participants who took at least one injection of double-blind (aripiprazole IM depot or placebo) and had at least one Post-Baseline efficacy assessment. Data of only 162 and 168 participants from aripiprazole and placebo groups were available.
Arm/Group Title Aripiprazole IM Depot 400/300mg Placebo
Hide Arm/Group Description:
Participants randomized to aripiprazole IM depot received aripiprazole IM depot 400 mg as the initial dose with a single decrease to aripiprazole IM depot 300 mg permitted for tolerability per the study physician. The study treatment was injected into gluteal muscle every 4 weeks (Baseline/Day, Week 4, Week 8) during the 12-Week Acute Treatment Phase (ie, 3 IM depot injections). For 14 days beginning with the first injection, participants received concomitant oral aripiprazole (10 to 20 mg/day based on the study physician's clinical judgment).
Participants randomized to Placebo group received matching placebo. For 14 days beginning with the first injection, participants received concomitant oral placebo.
Overall Number of Participants Analyzed 162 168
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Week 1 (N= 162, 168) -0.4  (0.1) -0.2  (0.1)
Week 2 (N= 144, 157) -0.8  (0.1) -0.4  (0.1)
Week 4 (N= 134, 140) -1.0  (0.1) -0.4  (0.1)
Week 6 (N= 126, 117) -1.2  (0.1) -0.5  (0.1)
Week 8 (N= 108, 96) -1.3  (0.1) -0.6  (0.1)
Week 10 (N= 99, 81) -1.4  (0.1) -0.6  (0.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aripiprazole IM Depot 400/300mg, Placebo
Comments Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments After the comparison for primary efficacy endpoint was statistically significant, the comparison of change from Baseline in CGI severity score was conducted at same alpha level 0.05.
Method Mixed Models Analysis
Comments MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.3
Confidence Interval (2-Sided) 95%
-0.4 to -0.1
Estimation Comments Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 1.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Aripiprazole IM Depot 400/300mg, Placebo
Comments Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments After the comparison for primary efficacy endpoint was statistically significant, the comparison of change from Baseline in CGI severity score was conducted at same alpha level 0.05.
Method Mixed Models Analysis
Comments MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.4
Confidence Interval (2-Sided) 95%
-0.6 to -0.2
Estimation Comments Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 2.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Aripiprazole IM Depot 400/300mg, Placebo
Comments Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments After the comparison for primary efficacy endpoint was statistically significant, the comparison of change from Baseline in CGI severity score was conducted at same alpha level 0.05.
Method Mixed Models Analysis
Comments MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.6
Confidence Interval (2-Sided) 95%
-0.7 to -0.4
Estimation Comments Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 4.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Aripiprazole IM Depot 400/300mg, Placebo
Comments Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments After the comparison for primary efficacy endpoint was statistically significant, the comparison of change from Baseline in CGI severity score was conducted at same alpha level 0.05.
Method Mixed Models Analysis
Comments MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.7
Confidence Interval (2-Sided) 95%
-0.9 to -0.5
Estimation Comments Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 6.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Aripiprazole IM Depot 400/300mg, Placebo
Comments Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments After the comparison for primary efficacy endpoint was statistically significant, the comparison of change from Baseline in CGI severity score was conducted at same alpha level 0.05.
Method Mixed Models Analysis
Comments MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.7
Confidence Interval (2-Sided) 95%
-0.9 to -0.5
Estimation Comments Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 8.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Aripiprazole IM Depot 400/300mg, Placebo
Comments Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments After the comparison for primary efficacy endpoint was statistically significant, the comparison of change from Baseline in CGI severity score was conducted at same alpha level 0.05.
Method Mixed Models Analysis
Comments MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.8
Confidence Interval (2-Sided) 95%
-1.1 to -0.6
Estimation Comments Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 10.
3.Secondary Outcome
Title Mean Change From Baseline to Endpoint in PANSS Positive Subscale Score.
Hide Description The PANSS consisted of three subscales that contained a total of 30 symptom constructs. For each symptom construct, severity is rated on a 7-point scale, with a score of 1 indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. In positive subscale, the 7 positive symptom constructs were: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. PANSS Positive Subscale Score ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms).
Time Frame Baseline to Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy sample was defined as the intent to treat (ITT) population which included randomized participants who took at least one injection of double-blind (aripiprazole IM depot or placebo) and had at least one Post-Baseline efficacy assessment. Data of only 162 and 167 participants from aripiprazole and placebo groups were available.
Arm/Group Title Aripiprazole IM Depot 400/300mg Placebo
Hide Arm/Group Description:
Participants randomized to aripiprazole IM depot received aripiprazole IM depot 400 mg as the initial dose with a single decrease to aripiprazole IM depot 300 mg permitted for tolerability per the study physician. The study treatment was injected into gluteal muscle every 4 weeks (Baseline/Day, Week 4, Week 8) during the 12-Week Acute Treatment Phase (ie, 3 IM depot injections). For 14 days beginning with the first injection, participants received concomitant oral aripiprazole (10 to 20 mg/day based on the study physician's clinical judgment).
Participants randomized to Placebo group received matching placebo. For 14 days beginning with the first injection, participants received concomitant oral placebo.
Overall Number of Participants Analyzed 162 167
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Week 1 (N= 162, 167) -3.5  (0.3) -2.1  (0.3)
Week 2 (N= 144, 157) -5.7  (0.4) -3.4  (0.4)
Week 4 (N= 134, 140) -7.0  (0.5) -3.9  (0.4)
Week 6 (N= 126, 117) -8.2  (0.5) -4.4  (0.5)
Week 8 (N= 108, 96) -8.9  (0.5) -4.1  (0.5)
Week 10 (N= 99, 81) -10.0  (0.5) -4.9  (0.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aripiprazole IM Depot 400/300mg, Placebo
Comments Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0006
Comments [Not Specified]
Method Mixed Models Analysis
Comments MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.4
Confidence Interval (2-Sided) 95%
-2.1 to -0.6
Estimation Comments Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 1.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Aripiprazole IM Depot 400/300mg, Placebo
Comments Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.3
Confidence Interval (2-Sided) 95%
-3.3 to -1.3
Estimation Comments Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 2.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Aripiprazole IM Depot 400/300mg, Placebo
Comments Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.1
Confidence Interval (2-Sided) 95%
-4.3 to -2.0
Estimation Comments Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 4.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Aripiprazole IM Depot 400/300mg, Placebo
Comments Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.8
Confidence Interval (2-Sided) 95%
-5.1 to -2.6
Estimation Comments Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 6.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Aripiprazole IM Depot 400/300mg, Placebo
Comments Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4.8
Confidence Interval (2-Sided) 95%
-6.2 to -3.4
Estimation Comments Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 8.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Aripiprazole IM Depot 400/300mg, Placebo
Comments Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -5.1
Confidence Interval (2-Sided) 95%
-6.4 to -3.7
Estimation Comments Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 10.
4.Secondary Outcome
Title Mean Change From Baseline to Endpoint in PANSS Negative Subscale Score.
Hide Description The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicated- absence of symptoms and a score of 7 indicated- extremely severe symptoms. The PANSS negative subscale score was the sum of the rating scores for the 7 negative scale items from the PANSS panel. The 7 negative symptom constructs were: blunted affect, emotional withdrawal, poor rapport, passive apathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation and stereotyped thinking. PANSS Negative Subscale Score ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms).
Time Frame Baseline to Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy sample was defined as the intent to treat (ITT) population which included randomized participants who took at least one injection of double-blind (aripiprazole IM depot or placebo) and had at least one Post-Baseline efficacy assessment. Data of only 162 and 167 participants from aripiprazole and placebo groups were available.
Arm/Group Title Aripiprazole IM Depot 400/300mg Placebo
Hide Arm/Group Description:
Participants randomized to aripiprazole IM depot received aripiprazole IM depot 400 mg as the initial dose with a single decrease to aripiprazole IM depot 300 mg permitted for tolerability per the study physician. The study treatment was injected into gluteal muscle every 4 weeks (Baseline/Day, Week 4, Week 8) during the 12-Week Acute Treatment Phase (ie, 3 IM depot injections). For 14 days beginning with the first injection, participants received concomitant oral aripiprazole (10 to 20 mg/day based on the study physician's clinical judgment).
Participants randomized to Placebo group received matching placebo. For 14 days beginning with the first injection, participants received concomitant oral placebo.
Overall Number of Participants Analyzed 162 167
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Week 1 (N= 162, 167) -1.6  (0.2) -0.7  (0.2)
Week 2 (N= 144, 157) -2.4  (0.3) -1.2  (0.3)
Week 4 (N= 134, 140) -3.1  (0.4) -1.3  (0.4)
Week 6 (N= 126, 117) -3.5  (0.4) -1.3  (0.4)
Week 8 (N= 108, 96) -4.0  (0.4) -1.4  (0.4)
Week 10 (N= 99, 81) -4.5  (0.5) -1.6  (0.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aripiprazole IM Depot 400/300mg, Placebo
Comments Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0023
Comments [Not Specified]
Method Mixed Models Analysis
Comments MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.9
Confidence Interval (2-Sided) 95%
-1.6 to -0.3
Estimation Comments Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 1.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Aripiprazole IM Depot 400/300mg, Placebo
Comments Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0032
Comments [Not Specified]
Method Mixed Models Analysis
Comments MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.2
Confidence Interval (2-Sided) 95%
-2.0 to -0.4
Estimation Comments Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 2.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Aripiprazole IM Depot 400/300mg, Placebo
Comments Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments [Not Specified]
Method Mixed Models Analysis
Comments MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.8
Confidence Interval (2-Sided) 95%
-2.7 to -0.8
Estimation Comments Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 4.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Aripiprazole IM Depot 400/300mg, Placebo
Comments Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.2
Confidence Interval (2-Sided) 95%
-3.2 to -1.3
Estimation Comments Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 6.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Aripiprazole IM Depot 400/300mg, Placebo
Comments Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.6
Confidence Interval (2-Sided) 95%
-3.7 to -1.4
Estimation Comments Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 8.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Aripiprazole IM Depot 400/300mg, Placebo
Comments Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.8
Confidence Interval (2-Sided) 95%
-4.1 to -1.6
Estimation Comments Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 10.
5.Secondary Outcome
Title Mean Change From Baseline to Endpoint in Personal and Social Performance Scale (PSP) Score.
Hide Description The PSP was a validated clinician scale that measured personal and social functionining in 4 domains: socially useful activities eg, work and study), personal and social relationships, self-care, disturbing and aggressive behaviours. Impairement in each of these domains was rated as absent, mild, manifest, marked, severe, or very severe. These ratings were then converted to a total score based on a 100-point scale using algorithms to identify the appropriate 10-point interval and the study physician's judgement to determine the total score within the 10-point interval. Participants with a PSP total score of 71 to 100 were considered to have mild functional difficulty. Scores of 31 to 70 represented varying degrees of disability (31 to 70) and ratings of 1 to 30 indicated minimal functioning that required intense support and/or supervision.
Time Frame Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy sample included participants who took at least one injection of double-blind (aripiprazole IM depot or placebo) and had one Post-Baseline efficacy assessment. LOCF was used to impute the missing data with the recorded value obtained at the preceding visit.
Arm/Group Title Aripiprazole IM Depot 400/300mg Placebo
Hide Arm/Group Description:
Participants randomized to aripiprazole IM depot received aripiprazole IM depot 400 mg as the initial dose with a single decrease to aripiprazole IM depot 300 mg permitted for tolerability per the study physician. The study treatment was injected into gluteal muscle every 4 weeks (Baseline/Day, Week 4, Week 8) during the 12-Week Acute Treatment Phase (ie, 3 IM depot injections). For 14 days beginning with the first injection, participants received concomitant oral aripiprazole (10 to 20 mg/day based on the study physician's clinical judgment).
Participants randomized to Placebo group received matching placebo. For 14 days beginning with the first injection, participants received concomitant oral placebo.
Overall Number of Participants Analyzed 139 146
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
12.3  (1.2) 5.2  (1.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aripiprazole IM Depot 400/300mg, Placebo
Comments Statistical analysis for Week 10.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA model with treatment and pooled centers as factors and Baseline value as covariate for the comparison at other visits.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 7.1
Confidence Interval (2-Sided) 95%
4.1 to 10.1
Estimation Comments Difference in least square mean of change were derived from ANCOVA model.
6.Secondary Outcome
Title Mean Clinical Global Impression-Improvement Scale (CGI-I) Score at Endpoint.
Hide Description The severity of illness for each participants were rated using the CGI-S scale. The study physician were to answer the following question: "Considering your total experience with this particular population, how mentally ill is the patient at this time?" Response choices included were: 0= not assessed; 1= normal; not at all ill; 2= borderline mentally ill; 3= mildly ill; 4= moderately ill; 5= markedly ill; 6= severely ill; and 7= among the most extremely ill participants.
Time Frame Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy sample was defined as the ITT population which included randomized participants who took at least one injection of double-blind (aripiprazole IM depot or placebo) and had at least one Post-Baseline efficacy assessment. LOCF was used to impute the missing data with the recorded value obtained at the preceding visit.
Arm/Group Title Aripiprazole IM Depot 400/300mg Placebo
Hide Arm/Group Description:
Participants randomized to aripiprazole IM depot received aripiprazole IM depot 400 mg as the initial dose with a single decrease to aripiprazole IM depot 300 mg permitted for tolerability per the study physician. The study treatment was injected into gluteal muscle every 4 weeks (Baseline/Day, Week 4, Week 8) during the 12-Week Acute Treatment Phase (ie, 3 IM depot injections). For 14 days beginning with the first injection, participants received concomitant oral aripiprazole (10 to 20 mg/day based on the study physician's clinical judgment).
Participants randomized to Placebo group received matching placebo. For 14 days beginning with the first injection, participants received concomitant oral placebo.
Overall Number of Participants Analyzed 162 168
Mean (Standard Deviation)
Unit of Measure: Units on a scale
2.7  (1.2) 3.7  (1.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aripiprazole IM Depot 400/300mg, Placebo
Comments Statistical analysis for Week 10. LOCF method were used in imputation of missing data.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments CMH raw mean scores differ test (Van Elteren test) controlling for pooled centers.
7.Secondary Outcome
Title Responder Rate Based on PANSS Total Score.
Hide Description Responder rate was defined as ≥30% reduction from Baseline in PANSS Total Score. PANSS Total Score ranged from 30 (best possible outcome) to 210 (worst possible outcome).
Time Frame Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy sample was defined as the ITT population which included randomized participants who took at least one injection of double-blind (aripiprazole IM depot or placebo) and had at least one Post-Baseline efficacy assessment. LOCF was used to impute the missing data with the recorded value obtained at the preceding visit.
Arm/Group Title Aripiprazole IM Depot 400/300mg Placebo
Hide Arm/Group Description:
Participants randomized to aripiprazole IM depot received aripiprazole IM depot 400 mg as the initial dose with a single decrease to aripiprazole IM depot 300 mg permitted for tolerability per the study physician. The study treatment was injected into gluteal muscle every 4 weeks (Baseline/Day, Week 4, Week 8) during the 12-Week Acute Treatment Phase (ie, 3 IM depot injections). For 14 days beginning with the first injection, participants received concomitant oral aripiprazole (10 to 20 mg/day based on the study physician's clinical judgment).
Participants randomized to Placebo group received matching placebo. For 14 days beginning with the first injection, participants received concomitant oral placebo.
Overall Number of Participants Analyzed 162 168
Measure Type: Number
Unit of Measure: participants
60 24
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aripiprazole IM Depot 400/300mg, Placebo
Comments Statistical analysis for Week 10. LOCF method were used in imputation of missing data.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments CMH test controlling by region (pooled sites).
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 22.7
Confidence Interval (2-Sided) 95%
12.9 to 32.4
Estimation Comments [Not Specified]
Time Frame Adverse events were monitored from ICF signed untill Follow-up 14 (± 2) days.
Adverse Event Reporting Description One participant was randomly assigned to aripiprazole IM depot 400 mg/ 300 mg, but was not treated and did not have any post-randomization assessments and was not included in safety or efficacy assessments.
 
Arm/Group Title Aripiprazole IM Depot 400/300mg Placebo
Hide Arm/Group Description Participants randomized to aripiprazole IM depot received aripiprazole IM depot 400 mg as the initial dose with a single decrease to aripiprazole IM depot 300 mg permitted for tolerability per the study physician. The study treatment was injected into gluteal muscle every 4 weeks (Baseline/Day, Week 4, Week 8) during the 12-Week Acute Treatment Phase (ie, 3 IM depot injections). For 14 days beginning with the first injection, participants received concomitant oral aripiprazole (10 to 20 mg/day based on the study physician's clinical judgment). Participants randomized to Placebo group received matching placebo. For 14 days beginning with the first injection, participants received concomitant oral placebo.
All-Cause Mortality
Aripiprazole IM Depot 400/300mg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Aripiprazole IM Depot 400/300mg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   8/167 (4.79%)   6/172 (3.49%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  1/167 (0.60%)  0/172 (0.00%) 
Psychiatric disorders     
Agitation * 1  1/167 (0.60%)  0/172 (0.00%) 
Psychotic disorder * 1  2/167 (1.20%)  2/172 (1.16%) 
Schizophrenia * 1  3/167 (1.80%)  3/172 (1.74%) 
Substance abuse * 1  1/167 (0.60%)  0/172 (0.00%) 
Suicidal ideation * 1  1/167 (0.60%)  0/172 (0.00%) 
Vascular disorders     
Hypotension * 1  0/167 (0.00%)  1/172 (0.58%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 15.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Aripiprazole IM Depot 400/300mg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   91/167 (54.49%)   68/172 (39.53%) 
Gastrointestinal disorders     
Constipation * 1  16/167 (9.58%)  12/172 (6.98%) 
Dyspepsia * 1  10/167 (5.99%)  11/172 (6.40%) 
Toothache * 1  9/167 (5.39%)  8/172 (4.65%) 
General disorders     
Injection site pain * 1  9/167 (5.39%)  1/172 (0.58%) 
Investigations     
Weight increased * 1  28/167 (16.77%)  12/172 (6.98%) 
Nervous system disorders     
Akathisia * 1  19/167 (11.38%)  6/172 (3.49%) 
Headache * 1  24/167 (14.37%)  28/172 (16.28%) 
Sedation * 1  9/167 (5.39%)  2/172 (1.16%) 
Psychiatric disorders     
Agitation * 1  9/167 (5.39%)  11/172 (6.40%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  10/167 (5.99%)  10/172 (5.81%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 15.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Global Medical Affairs
Organization: Otsuka Pharmaceutical Development and Commercialization, Inc.
Phone: 800 562-3974
Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT01663532     History of Changes
Other Study ID Numbers: 31-12-291
First Submitted: August 9, 2012
First Posted: August 13, 2012
Results First Submitted: December 19, 2014
Results First Posted: February 16, 2015
Last Update Posted: February 16, 2015