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Comparing the Effect of Under the Tongue Olanzapine Versus Swallowed Olanzapine on Body Mass Index (A Ratio of Weight to Height)

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ClinicalTrials.gov Identifier: NCT00303602
Recruitment Status : Completed
First Posted : March 17, 2006
Results First Posted : June 2, 2009
Last Update Posted : June 10, 2009
Sponsor:
Information provided by:
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Schizophrenia
Schizoaffective Disorder
Bipolar Disorder
Interventions Drug: Sublingual orally disintegrating olanzapine (SODO)
Drug: Oral olanzapine
Enrollment 149
Recruitment Details  
Pre-assignment Details  
Arm/Group Title SODO SOT
Hide Arm/Group Description Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
Period Title: Overall Study
Started 84 65
Completed 65 50
Not Completed 19 15
Reason Not Completed
Adverse Event             2             2
Withdrawal by Subject             5             6
Lost to Follow-up             5             2
Protocol entry criteria not met             2             2
Physician Decision             2             1
Noncompliance             2             2
Protocol Violation             1             0
Arm/Group Title SODO SOT Total
Hide Arm/Group Description Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks Total of all reporting groups
Overall Number of Baseline Participants 84 65 149
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 84 participants 65 participants 149 participants
38.6  (13.13) 38.7  (12.23) 38.6  (12.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 84 participants 65 participants 149 participants
Female
36
  42.9%
32
  49.2%
68
  45.6%
Male
48
  57.1%
33
  50.8%
81
  54.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 84 participants 65 participants 149 participants
United States 23 18 41
Mexico 27 23 50
Canada 29 21 50
Netherlands 5 3 8
Presence of Metabolic Syndrome  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 84 participants 65 participants 149 participants
No 64 49 113
Yes 18 16 34
Unknown 2 0 2
Psychiatric Illness  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 84 participants 65 participants 149 participants
Schizophrenia 46 36 82
Schizophreniform 7 2 9
Schizoaffective disorder 3 12 15
Other related psychiatric disorder 1 1 2
Bipolar disorder 27 14 41
Race/Ethnicity  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 84 participants 65 participants 149 participants
African Descent 11 4 15
Caucasian 42 36 78
East/Southeast Asian 2 1 3
First Nations 2 0 2
Hispanic 27 23 50
Other 0 1 1
Blood Pressure  
Mean (Standard Deviation)
Unit of measure:  Mm Hg
Number Analyzed 84 participants 65 participants 149 participants
Systolic Blood Pressure 120.3  (16.45) 119.0  (12.49) 119.7  (14.82)
Diastolic Blood Pressure 77.6  (9.62) 75.8  (9.15) 76.8  (9.43)
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kilograms/meters-squared
Number Analyzed 84 participants 65 participants 149 participants
28.0  (5.63) 28.3  (4.76) 28.1  (5.26)
Clinical Global Impression-Severity Scale   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 84 participants 65 participants 149 participants
3.0  (0.78) 3.2  (0.85) 3.1  (0.81)
[1]
Measure Description: Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients.
Fasting Glucose  
Mean (Standard Deviation)
Unit of measure:  millimole/Liter
Number Analyzed 84 participants 65 participants 149 participants
5.1  (0.77) 5.0  (0.46) 5.1  (0.65)
Fasting Insulin  
Mean (Standard Deviation)
Unit of measure:  Micro International Unit/milliliter
Number Analyzed 84 participants 65 participants 149 participants
13.5  (14.65) 10.0  (7.18) 11.9  (12.06)
Fasting Lipoproteins  
Mean (Standard Deviation)
Unit of measure:  millimole/Liter
Number Analyzed 84 participants 65 participants 149 participants
Total Cholesterol 5.1  (1.01) 5.1  (1.01) 5.1  (1.0)
High-Density Lipoprotein Cholesterol 1.2  (0.40) 1.3  (0.34) 1.3  (0.37)
Low-Density Lipoprotein Cholesterol 3.1  (0.81) 3.0  (0.88) 3.1  (0.84)
Triglycerides 1.7  (0.77) 1.7  (0.90) 1.7  (0.83)
Global Assessment of Functioning Scale   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 84 participants 65 participants 149 participants
63.4  (12.82) 62.5  (12.39) 63.0  (12.60)
[1]
Measure Description: Measures physician's judgment of a patient's overall level of functioning. Ratings are based on a scale of 1 to 100, with the following classification range: 1-10 (severely impaired) to 91-100 (superior functioning).
Glycosylated Hemoglobin  
Mean (Standard Deviation)
Unit of measure:  Percent
Number Analyzed 84 participants 65 participants 149 participants
5.5  (0.45) 5.5  (0.38) 5.5  (0.42)
Height  
Mean (Standard Deviation)
Unit of measure:  Centimeters
Number Analyzed 84 participants 65 participants 149 participants
170.0  (10.18) 168.9  (10.23) 169.5  (10.18)
Subjective Appetite (Visual Analog Scale)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 84 participants 65 participants 149 participants
62.5  (20.85) 65.7  (19.24) 63.9  (20.16)
[1]
Measure Description: Participant chooses where they think their appetite lies on a 10 centimeter line between two anchors (0 - very poor appetite and 10 - very strong appetite). The possible range of scores is 0 to 100 and represents millimeters on the 10 centimeter line.
Subjective Well-Being Under Neuroleptic Treatment - Short Form   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 84 participants 65 participants 149 participants
Total Score 85.5  (15.59) 85.6  (15.00) 85.5  (15.28)
Social Integration Subscale 17.0  (4.38) 17.0  (3.97) 17.0  (4.19)
Physical Functioning Subscale 17.0  (3.53) 17.2  (3.26) 17.1  (3.41)
Mental Functioning Subscale 16.7  (4.02) 16.7  (4.20) 16.7  (4.09)
Self-Control Subscale 17.0  (3.45) 17.3  (4.15) 17.1  (3.76)
Emotional Regulation Subscale 17.6  (4.07) 17.4  (3.82) 17.5  (3.95)
[1]
Measure Description: Measures subjective well-being for previous 7 days. 20 items covering 5 health domains (subscales) (4 items each): emotional regulation, self-control, mental functioning, social integration, and physical functioning. Individual scores range from 1 (not at all) to 6 (very much). Subscale scores range from 4 to 24. Total score ranges from 20 to 120.
Waist Circumference  
Mean (Standard Deviation)
Unit of measure:  Centimeters
Number Analyzed 84 participants 65 participants 149 participants
96.1  (13.24) 97.2  (12.97) 96.6  (13.09)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilograms
Number Analyzed 84 participants 65 participants 149 participants
81.1  (18.97) 81.2  (17.05) 81.1  (18.10)
1.Primary Outcome
Title Time Course of Change From Baseline in Body Mass Index (BMI)
Hide Description Body mass index is an estimate of body fat based on body weight divided by height squared. Comparison of changes at various time points throughout the study. Change = Time point value minus baseline (Visit 2) value.
Time Frame Visit 2 (Baseline) to Visit 7 (16 Weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat
Arm/Group Title SODO SOT
Hide Arm/Group Description:
Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
Overall Number of Participants Analyzed 82 63
Least Squares Mean (Standard Error)
Unit of Measure: kilograms/square meters
Week 2 (N=82, N=63) 0.09  (0.06) 0.16  (0.07)
Week 4 (N=79, N=63) 0.25  (0.08) 0.27  (0.09)
Week 8 (N=75, N=58) 0.34  (0.12) 0.32  (0.13)
Week 12 (N=70, N=54) 0.47  (0.16) 0.54  (0.18)
Week 16 (N=67, N=51) 0.52  (0.18) 0.72  (0.20)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SODO, SOT
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.428
Comments P-value for Week 2 Change from Baseline. There was no adjustment for multiple comparisons.
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection SODO, SOT
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.859
Comments P-value for Week 4 Change from Baseline. There was no adjustment for multiple comparisons.
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection SODO, SOT
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.885
Comments P-value for Week 8 Change from Baseline. There was no adjustment for multiple comparisons.
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection SODO, SOT
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.784
Comments P-value for Week 12 Change from Baseline. There was no adjustment for multiple comparisons.
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection SODO, SOT
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.465
Comments P-value for Week 16 Change from Baseline. There was no adjustment for multiple comparisons
Method Mixed Models Analysis
Comments [Not Specified]
2.Secondary Outcome
Title Mean Change From Baseline to 16 Week Endpoint in Body Mass Index (BMI)
Hide Description Body mass index is an estimate of body fat based on body weight divided by height squared. Comparison of change from baseline to endpoint. Change = Endpoint (Week 16) minus Baseline (Week 0)
Time Frame Visit 2 (Baseline) and Visit 7 (Week 16)
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat with last observation carried forward
Arm/Group Title SODO SOT
Hide Arm/Group Description:
Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
Overall Number of Participants Analyzed 82 63
Mean (Standard Deviation)
Unit of Measure: kilograms/square meters
0.52  (1.49) 0.67  (1.44)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SODO, SOT
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.442
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Square Mean Change Difference
Estimated Value -0.19
Confidence Interval 95%
-0.67 to 0.30
Estimation Comments Change = Endpoint minus baseline
3.Secondary Outcome
Title Mean Change From Baseline to 16 Week Endpoint in Body Mass Index (BMI) for the Treatment Completers
Hide Description Body mass index is an estimate of body fat based on body weight divided by height squared. Comparisons of change from baseline to endpoint between participants who completed their treatment. Change = Endpoint value minus Baseline value.
Time Frame Visit 2 (Baseline) and Visit 7 (16 Weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol
Arm/Group Title SODO SOT
Hide Arm/Group Description:
Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
Overall Number of Participants Analyzed 60 47
Mean (Standard Deviation)
Unit of Measure: kilograms/square meters
0.56  (1.59) 0.79  (1.58)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SODO, SOT
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.328
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Square Mean Change Difference
Estimated Value -0.32
Confidence Interval 95%
-0.95 to 0.32
Estimation Comments Change = Endpoint minus baseline
4.Secondary Outcome
Title Mean Change From Baseline to 16 Week Endpoint in Weight
Hide Description Weight of undressed patient (undergarments allowed), measured preferably at the same time each day.
Time Frame Visit 2 (Baseline) and Visit 7 (16 Weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat
Arm/Group Title SODO SOT
Hide Arm/Group Description:
Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
Overall Number of Participants Analyzed 67 51
Least Squares Mean (Standard Error)
Unit of Measure: kilograms
1.42  (0.50) 2.08  (0.57)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SODO, SOT
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.385
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
5.Secondary Outcome
Title Mean Change From Baseline to 16 Week Endpoint in Waist Circumference
Hide Description Waist circumference is measured on a bare abodomen just above the hip bone.
Time Frame Visit 2 (Baseline) and Visit 7 (Week 16)
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat with last observation carried forward
Arm/Group Title SODO SOT
Hide Arm/Group Description:
Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
Overall Number of Participants Analyzed 76 58
Mean (Standard Deviation)
Unit of Measure: centimeters
1.13  (5.25) 0.77  (5.30)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SODO, SOT
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.914
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Square Mean Change Difference
Estimated Value 0.10
Confidence Interval 95%
-1.65 to 1.84
Estimation Comments Change = endpoint minus baseline
6.Secondary Outcome
Title Number of Patients Achieving at Least 5% Loss of Body Weight in Any Post-Baseline Period
Hide Description Percentage loss of body weight = 100*(postbaseline weight - baseline weight)/baseline weight
Time Frame Visit 2 (Baseline) to Visit 7 (Week 16)
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat
Arm/Group Title SODO SOT
Hide Arm/Group Description:
Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
Overall Number of Participants Analyzed 84 65
Measure Type: Number
Unit of Measure: participants
Up to Week 2 (N=82, N=63) 0 0
Up to Week 4 (N=79, N=63) 0 1
Up to Week 8 (N=75, N=58) 2 2
Up to Week 12 (N=70, N=54) 3 4
Up to Week 16 (N=67, N=51) 4 6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SODO, SOT
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.325
Comments Up to Week 16 p-value
Method Fisher Exact
Comments [Not Specified]
7.Secondary Outcome
Title Number of Participants Discontinuing the Trial by Visit (Week)
Hide Description The number of participants who discontinued by visit (non-cumulative).
Time Frame Visit 2 (Baseline) to Visit 7 (Week 16)
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat
Arm/Group Title SODO SOT
Hide Arm/Group Description:
Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
Overall Number of Participants Analyzed 84 65
Measure Type: Number
Unit of Measure: participants
Visit 3 (Week 2) Discontinuations 3 1
Visit 4 (Week 4) Discontinuations 3 1
Visit 5 (Week 8) Discontinuations 5 6
Visit 6 (Week 12) Discontinuations 5 6
Visit 7 (Week 16) Discontinuations 3 1
8.Secondary Outcome
Title Change From Baseline to 16 Week Endpoint in Subjective Appetite Using a Visual Analog Scale
Hide Description Participant chooses where they think their appetite lies on a 10 centimeter line between two anchors (0 - very poor appetite and 10 - very strong appetite). The possible range of scores is 0 to 100 and represents millimeters on the 10 centimeter line.
Time Frame Visit 2 (Baseline) and Visit 7 (Week 16)
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat
Arm/Group Title SODO SOT
Hide Arm/Group Description:
Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
Overall Number of Participants Analyzed 82 63
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-8.21  (2.26) -5.02  (2.59)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SODO, SOT
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.344
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
9.Secondary Outcome
Title Mean Change From Baseline to 16 Week Endpoint in Blood Pressure
Hide Description Sitting blood pressure, taken from the same arm.
Time Frame Visit 2 (Baseline) and Visit 7 (Week 16)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population with last observation carried forward
Arm/Group Title SODO SOT
Hide Arm/Group Description:
Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
Overall Number of Participants Analyzed 74 55
Mean (Standard Deviation)
Unit of Measure: mm Hg
Systolic Blood Pressure 0.1  (11.62) -0.1  (10.83)
Diastolic Blood Pressure 0.3  (7.55) 0.8  (8.35)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SODO, SOT
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.708
Comments Systolic Blood Pressure Change to Endpoint p-value
Method Rank-Sum Test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection SODO, SOT
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.453
Comments Diastolic Blood Pressure Change to Endpoint p-value
Method Rank-Sum Test
Comments [Not Specified]
10.Secondary Outcome
Title Mean Change From Baseline to 16 Week Endpoint in Fasting Lipoproteins (Total Cholesterol, High-Density Lipoprotein Cholesterol [HDL-Cholesterol], Low-Density Lipoprotein Cholesterol [LDL-Cholesterol] [Calculated], and Triglycerides)
Hide Description Patients should be fasting a minimum of eight hours prior to lipoprotein measurements.
Time Frame Visit 2 (Baseline) and Visit 7 (Week 16)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population with last observation carried forward
Arm/Group Title SODO SOT
Hide Arm/Group Description:
Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
Overall Number of Participants Analyzed 74 57
Mean (Standard Deviation)
Unit of Measure: millimole/Liter
Total Cholesterol 0.1  (0.74) 0.2  (0.79)
High-Density Lipoprotein Cholesterol -0.0  (0.24) -0.0  (0.24)
Low-Density Lipoprotein Cholesterol (N=73, N=57) 0.1  (0.66) 0.2  (0.53)
Triglycerides 0.1  (0.84) 0.0  (1.01)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SODO, SOT
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.187
Comments Total Cholesterol Change to Endpoint p-value
Method Cochran-Mantel-Haenszel
Comments Ranks of change from baseline were regressed on ranks of baseline value of assay. Treatments compared using residuals of this regression in CMH test.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection SODO, SOT
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.163
Comments High-Density Lipoprotein Cholesterol Change to Endpoint p-value
Method Cochran-Mantel-Haenszel
Comments Ranks of change from baseline were regressed on ranks of baseline value of assay. Treatments compared using residuals of this regression in CMH test.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection SODO, SOT
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.323
Comments Low-Density Lipoprotein Cholesterol Change to Endpoint p-value
Method Cochran-Mantel-Haenszel
Comments Ranks of change from baseline were regressed on ranks of baseline value of assay. Treatments compared using residuals of this regression in CMH test.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection SODO, SOT
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.581
Comments Triglycerides Change to Endpoint p-value
Method Cochran-Mantel-Haenszel
Comments Ranks of change from baseline were regressed on ranks of baseline value of assay. Treatments compared using residuals of this regression in CMH test.
11.Secondary Outcome
Title Change From Baseline to 16 Week Endpoint in Fasting Plasma Glucose
Hide Description Patients should be fasting a minimum of eight hours prior to plasma glucose measurement.
Time Frame Visit 2 (Baseline) and Visit 7 (Week 16)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population with last observation carried forward
Arm/Group Title SODO SOT
Hide Arm/Group Description:
Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
Overall Number of Participants Analyzed 75 57
Mean (Standard Deviation)
Unit of Measure: millimole/Liter
0.2  (0.79) 0.1  (0.48)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SODO, SOT
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.227
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Ranks of change from baseline were regressed on ranks of baseline value of assay. Treatments compared using residuals of this regression in CMH test.
12.Secondary Outcome
Title Mean Change From Baseline to 16 Week Endpoint in Fasting Serum Insulin
Hide Description Patients should be fasting a minimum of eight hours prior to serum insulin measurement.
Time Frame Visit 2 (Baseline) and Visit 7 (Week 16)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population with last observation carried forward
Arm/Group Title SODO SOT
Hide Arm/Group Description:
Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
Overall Number of Participants Analyzed 65 52
Mean (Standard Deviation)
Unit of Measure: microIU/milliliter
2.4  (17.72) -0.1  (5.52)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SODO, SOT
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.020
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Ranks of change from baseline were regressed on ranks of baseline value of assay. Treatments compared using residuals of this regression in CMH test.
13.Secondary Outcome
Title Mean Change From Baseline to 16 Week Endpoint in Glycosylated Hemoglobin
Hide Description [Not Specified]
Time Frame Visit 2 (Baseline) and Visit 7 (Week 16)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population with last observation carried forward
Arm/Group Title SODO SOT
Hide Arm/Group Description:
Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
Overall Number of Participants Analyzed 75 57
Mean (Standard Deviation)
Unit of Measure: percent
0.0  (0.24) 0.0  (0.28)
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Statistical Analysis Overview Comparison Group Selection SODO, SOT
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.834
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Ranks of change from baseline were regressed on ranks of baseline value of assay. Treatments compared using residuals of this regression in CMH test.
14.Secondary Outcome
Title Mean Changes From Baseline to 16 Week Endpoint Homeostasis Model Assessments of Insulin Sensitivity HOMA-S (Calculated)
Hide Description HOMA-S is an estimate of insulin sensitivity. The HOMA model is a computer model of the glucose insulin feedback system in the fasted state. The model consists of a number of non-linear empirical equations describing the functions of organs and tissues involved in glucose regulation.
Time Frame Visit 2 (Baseline) and Visit 7 (Week 16)
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Hide Analysis Population Description
Safety population with last observation carried forward.
Arm/Group Title SODO SOT
Hide Arm/Group Description:
Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
Overall Number of Participants Analyzed 59 46
Mean (Standard Deviation)
Unit of Measure: percent sensitivity
-18.5  (58.91) -9.8  (62.61)
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Statistical Analysis Overview Comparison Group Selection SODO, SOT
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.022
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Ranks of change from baseline were regressed on ranks of baseline value of assay. Treatments compared using residuals on this regression in CMH test.
15.Secondary Outcome
Title Number of Participants Meeting a Definition for the Presence of Metabolic Syndrome as Defined by Adult Treatment Panel III (ATP III) Criteria at Baseline and 16 Week Endpoint
Hide Description Patient meets definition of metabolic syndrome if they have >=3 risk factors: Waist circumference (men>102cm, women>88cm); triglycerides >=1.7mmol/L; HDL cholesterol (men<1.04mmol/L, women<1.30mmol/L); blood pressure >135/>=85 mmHg; Fasting glucose >=6.1mmol/L
Time Frame Visit 2 (Baseline) and Visit 7 (Week 16)
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Hide Analysis Population Description
Intention to treat
Arm/Group Title SODO SOT
Hide Arm/Group Description:
Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
Overall Number of Participants Analyzed 84 65
Measure Type: Number
Unit of Measure: participants
Baseline - Metabolic Syndrome (N=82, N=65) 18 16
Endpoint - Metabolic Syndrome (N=70, N=52) 18 10
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Statistical Analysis Overview Comparison Group Selection SODO, SOT
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.515
Comments Endpoint Metabolic Syndrome p-value
Method Fisher Exact
Comments [Not Specified]
16.Secondary Outcome
Title Mean Change From Baseline to 16 Week Endpoint in the Clinical Global Impression-Severity (CGI-S) Scale
Hide Description Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
Time Frame Visit 2 (Baseline) and Visit 7 (Week 16)
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Hide Analysis Population Description
Intention to treat
Arm/Group Title SODO SOT
Hide Arm/Group Description:
Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
Overall Number of Participants Analyzed 67 51
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.26  (0.07) -0.09  (0.08)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SODO, SOT
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.118
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
17.Secondary Outcome
Title Mean Change From Baseline to 16 Week Endpoint in the Subjective Well-Being Under Neuroleptics (SWN) Scale
Hide Description Measures subjective well-being for previous 7 days. 20 items covering 5 health domains (subscales) (4 items each): emotional regulation, self-control, mental functioning, social integration, and physical functioning. Individual scores range from 1 (not at all) to 6 (very much). Subscale scores range from 1 to 24. Total score ranges from 1 to 120.
Time Frame Visit 2 (Baseline) and Visit 7 (Week 16)
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat
Arm/Group Title SODO SOT
Hide Arm/Group Description:
Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
Overall Number of Participants Analyzed 65 49
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
4.79  (1.52) 1.60  (1.73)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SODO, SOT
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.161
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
18.Secondary Outcome
Title Mean Change From Baseline to 16 Week Endpoint in the Global Assessment of Functioning (GAF) Scale
Hide Description Measures physician's judgment of a patient's overall level of functioning. Ratings are based on a scale of 1 to 100, with the following classification range: 1-10 (severely impaired) to 91-100 (superior functioning).
Time Frame Visit 2 (Baseline) and Visit 7 (Week 16)
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat
Arm/Group Title SODO SOT
Hide Arm/Group Description:
Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
Overall Number of Participants Analyzed 67 51
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
4.61  (1.05) 2.72  (1.20)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SODO, SOT
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.229
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title SODO SOT
Hide Arm/Group Description Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
All-Cause Mortality
SODO SOT
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
SODO SOT
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2      0    
Nervous system disorders     
Dizziness  1  1/84 (1.19%)  1 0/65 (0.00%)  0
Psychiatric disorders     
Suicide attempt  1  1/84 (1.19%)  1 0/65 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 8.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
SODO SOT
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   32      32    
Eye disorders     
Dry eye  1  0/84 (0.00%)  0 1/65 (1.54%)  1
Vision blurred  1  0/84 (0.00%)  0 1/65 (1.54%)  1
Gastrointestinal disorders     
Constipation  1  3/84 (3.57%)  3 1/65 (1.54%)  1
Diarrhoea  1  1/84 (1.19%)  1 0/65 (0.00%)  0
Dry mouth  1  1/84 (1.19%)  1 2/65 (3.08%)  2
Dyspepsia  1  1/84 (1.19%)  1 2/65 (3.08%)  2
Gastritis  1  0/84 (0.00%)  0 1/65 (1.54%)  1
Nausea  1  0/84 (0.00%)  0 1/65 (1.54%)  1
Tongue spasm  1  0/84 (0.00%)  0 1/65 (1.54%)  1
Tooth fracture  1  0/84 (0.00%)  0 1/65 (1.54%)  1
Umbilical hernia  1  1/84 (1.19%)  1 0/65 (0.00%)  0
Vomiting  1  1/84 (1.19%)  2 0/65 (0.00%)  0
General disorders     
Asthenia  1  0/84 (0.00%)  0 1/65 (1.54%)  1
Fatigue  1  3/84 (3.57%)  4 5/65 (7.69%)  6
Tenderness  1  0/84 (0.00%)  0 1/65 (1.54%)  1
Infections and infestations     
Eye infection  1  1/84 (1.19%)  1 0/65 (0.00%)  0
Influenza  1  0/84 (0.00%)  0 2/65 (3.08%)  2
Localised infection  1  0/84 (0.00%)  0 1/65 (1.54%)  1
Lower respiratory tract infection  1  1/84 (1.19%)  1 0/65 (0.00%)  0
Nasopharyngitis  1  1/84 (1.19%)  1 3/65 (4.62%)  3
Injury, poisoning and procedural complications     
Back injury  1  0/84 (0.00%)  0 1/65 (1.54%)  1
Sunburn  1  1/84 (1.19%)  1 0/65 (0.00%)  0
Investigations     
Blood potassium decreased  1  1/84 (1.19%)  1 0/65 (0.00%)  0
Blood triglycerides increased  1  1/84 (1.19%)  1 0/65 (0.00%)  0
Weight increased  1  0/84 (0.00%)  0 1/65 (1.54%)  1
Metabolism and nutrition disorders     
Decreased appetite  1  3/84 (3.57%)  3 0/65 (0.00%)  0
Hyperlipidaemia  1  1/84 (1.19%)  1 0/65 (0.00%)  0
Increased appetite  1  9/84 (10.71%)  9 10/65 (15.38%)  10
Musculoskeletal and connective tissue disorders     
Arthralgia  1  0/84 (0.00%)  0 2/65 (3.08%)  2
Arthritis  1  0/84 (0.00%)  0 1/65 (1.54%)  1
Chest wall pain  1  1/84 (1.19%)  1 0/65 (0.00%)  0
Coccydynia  1  1/84 (1.19%)  1 0/65 (0.00%)  0
Joint swelling  1  1/84 (1.19%)  1 0/65 (0.00%)  0
Muscle rigidity  1  1/84 (1.19%)  1 0/65 (0.00%)  0
Muscle spasms  1  1/84 (1.19%)  1 0/65 (0.00%)  0
Muscle twitching  1  1/84 (1.19%)  1 0/65 (0.00%)  0
Tendonitis  1  0/84 (0.00%)  0 1/65 (1.54%)  1
Nervous system disorders     
Akathisia  1  2/84 (2.38%)  2 2/65 (3.08%)  2
Disturbance in attention  1  0/84 (0.00%)  0 1/65 (1.54%)  1
Dizziness  1  0/84 (0.00%)  0 4/65 (6.15%)  4
Headache  1  5/84 (5.95%)  6 5/65 (7.69%)  5
Paraesthesia  1  1/84 (1.19%)  1 1/65 (1.54%)  1
Sedation  1  0/84 (0.00%)  0 1/65 (1.54%)  1
Somnolence  1  5/84 (5.95%)  5 5/65 (7.69%)  6
Syncope  1  1/84 (1.19%)  1 0/65 (0.00%)  0
Tongue paralysis  1  1/84 (1.19%)  1 0/65 (0.00%)  0
Tremor  1  1/84 (1.19%)  1 2/65 (3.08%)  2
Psychiatric disorders     
Anxiety  1  3/84 (3.57%)  3 2/65 (3.08%)  3
Depression  1  3/84 (3.57%)  3 2/65 (3.08%)  2
Insomnia  1  2/84 (2.38%)  2 3/65 (4.62%)  3
Irritability  1  0/84 (0.00%)  0 1/65 (1.54%)  1
Libido decreased  1  1/84 (1.19%)  1 0/65 (0.00%)  0
Psychomotor agitation  1  1/84 (1.19%)  1 0/65 (0.00%)  0
Psychotic disorder  1  1/84 (1.19%)  1 0/65 (0.00%)  0
Renal and urinary disorders     
Pollakiuria  1  0/84 (0.00%)  0 1/65 (1.54%)  1
Polyuria  1  1/84 (1.19%)  1 1/65 (1.54%)  1
Urinary incontinence  1  0/84 (0.00%)  0 1/65 (1.54%)  1
Respiratory, thoracic and mediastinal disorders     
Cough  1  0/84 (0.00%)  0 1/65 (1.54%)  1
Skin and subcutaneous tissue disorders     
Hyperhidrosis  1  0/84 (0.00%)  0 1/65 (1.54%)  1
Rash  1  0/84 (0.00%)  0 1/65 (1.54%)  1
Vascular disorders     
Haematoma  1  0/84 (0.00%)  0 1/65 (1.54%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 8.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 1-800-545-5979
Layout table for additonal information
Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00303602     History of Changes
Other Study ID Numbers: 10268
F1D-CA-S063
First Submitted: March 15, 2006
First Posted: March 17, 2006
Results First Submitted: December 19, 2008
Results First Posted: June 2, 2009
Last Update Posted: June 10, 2009