Trial Outcomes & Findings for Safety Study of Olanzapine and a Comparator in Patients With Schizophrenia and Schizoaffective Disorder (NCT NCT00190749)
NCT ID: NCT00190749
Last Updated: 2010-05-04
Results Overview
Normalized insulin sensitivity index (Mffm/I) was defined as the ratio of whole body glucose disposal rate normalized to fat-free mass (Mffm) divided by the plasma insulin concentration (I) during steady-state conditions of the clamp procedure. Units:\[(mg glucose)\*min\*mL\] / \[(kg fat free body mass)\*(micro IU insulin)\]
COMPLETED
PHASE4
130 participants
baseline and 12 weeks
2010-05-04
Participant Flow
Study Period I was a Screening Period. Study Period II was a Inpatient Washout/Diet Stabilization Period. Study Period III (randomization) was the Double-Blind Therapy Period.
Participant milestones
| Measure |
Olanzapine
Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
|
Risperidone
Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
68
|
62
|
|
Overall Study
COMPLETED
|
42
|
31
|
|
Overall Study
NOT COMPLETED
|
26
|
31
|
Reasons for withdrawal
| Measure |
Olanzapine
Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
|
Risperidone
Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
8
|
11
|
|
Overall Study
Withdrawal by Subject
|
10
|
6
|
|
Overall Study
Protocol Violation
|
5
|
4
|
|
Overall Study
Adverse Event
|
0
|
5
|
|
Overall Study
Lack of Efficacy
|
2
|
3
|
|
Overall Study
Reason Not Specified
|
0
|
2
|
|
Overall Study
Sponsor Decision
|
1
|
0
|
Baseline Characteristics
Safety Study of Olanzapine and a Comparator in Patients With Schizophrenia and Schizoaffective Disorder
Baseline characteristics by cohort
| Measure |
Olanzapine
n=68 Participants
Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
|
Risperidone
n=62 Participants
Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
|
Total
n=130 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
43.49 years
STANDARD_DEVIATION 9.45 • n=5 Participants
|
42.58 years
STANDARD_DEVIATION 8.98 • n=7 Participants
|
43.06 years
STANDARD_DEVIATION 9.20 • n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
68 participants
n=5 Participants
|
62 participants
n=7 Participants
|
130 participants
n=5 Participants
|
|
Diagnosis
Schizophrenia,paranoid
|
40 participants
n=5 Participants
|
45 participants
n=7 Participants
|
85 participants
n=5 Participants
|
|
Diagnosis
Schizoaffective disorder
|
27 participants
n=5 Participants
|
16 participants
n=7 Participants
|
43 participants
n=5 Participants
|
|
Diagnosis
Schizophrenia, undifferentiated
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Race/Ethnicity
Caucasian
|
27 participants
n=5 Participants
|
30 participants
n=7 Participants
|
57 participants
n=5 Participants
|
|
Race/Ethnicity
African descent
|
34 participants
n=5 Participants
|
26 participants
n=7 Participants
|
60 participants
n=5 Participants
|
|
Race/Ethnicity
Hispanic
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Race/Ethnicity
East Asian
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity
Other
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Brief Psychiatric Rating Scale Anxiety Depression Score-Baseline
|
4.46 units on a scale
STANDARD_DEVIATION 2.46 • n=5 Participants
|
3.74 units on a scale
STANDARD_DEVIATION 2.13 • n=7 Participants
|
4.12 units on a scale
STANDARD_DEVIATION 2.33 • n=5 Participants
|
|
Brief Psychiatric Rating Scale Negative Symptom Score-Baseline
|
2.28 units on a scale
STANDARD_DEVIATION 1.98 • n=5 Participants
|
1.89 units on a scale
STANDARD_DEVIATION 1.79 • n=7 Participants
|
2.09 units on a scale
STANDARD_DEVIATION 1.89 • n=5 Participants
|
|
Brief Psychiatric Rating Scale Positive Symptom Score-Baseline
|
5.40 units on a scale
STANDARD_DEVIATION 2.69 • n=5 Participants
|
5.47 units on a scale
STANDARD_DEVIATION 2.52 • n=7 Participants
|
5.43 units on a scale
STANDARD_DEVIATION 2.60 • n=5 Participants
|
|
Brief Psychiatric Rating Scale Total Score-Baseline
|
15.63 units on a scale
STANDARD_DEVIATION 6.06 • n=5 Participants
|
14.29 units on a scale
STANDARD_DEVIATION 6.00 • n=7 Participants
|
14.99 units on a scale
STANDARD_DEVIATION 6.04 • n=5 Participants
|
|
Clinical Global Impression Severity Score- Baseline
|
3.68 units on a scale
STANDARD_DEVIATION 0.56 • n=5 Participants
|
3.65 units on a scale
STANDARD_DEVIATION 0.52 • n=7 Participants
|
3.66 units on a scale
STANDARD_DEVIATION 0.54 • n=5 Participants
|
|
Extrapyramidal Scores/Abnormal Involuntary Movement-Baseline
|
0.42 units on a scale
STANDARD_DEVIATION 1.14 • n=5 Participants
|
0.47 units on a scale
STANDARD_DEVIATION 1.13 • n=7 Participants
|
0.44 units on a scale
STANDARD_DEVIATION 1.13 • n=5 Participants
|
|
Extrapyramidal Scores/Barnes Akathisia Rating Scale (BARS) Global Clinical Assessment-Baseline
|
0.27 units on a scale
STANDARD_DEVIATION 0.66 • n=5 Participants
|
0.32 units on a scale
STANDARD_DEVIATION 0.67 • n=7 Participants
|
0.29 units on a scale
STANDARD_DEVIATION 0.67 • n=5 Participants
|
|
Extrapyramidal Scores/Simpson-Angus-Baseline
|
0.97 units on a scale
STANDARD_DEVIATION 1.87 • n=5 Participants
|
0.90 units on a scale
STANDARD_DEVIATION 1.80 • n=7 Participants
|
0.94 units on a scale
STANDARD_DEVIATION 1.83 • n=5 Participants
|
PRIMARY outcome
Timeframe: baseline and 12 weeksPopulation: N=number of patients with a baseline and post-baseline result within each treatment group for Mffm/I and weight.
Normalized insulin sensitivity index (Mffm/I) was defined as the ratio of whole body glucose disposal rate normalized to fat-free mass (Mffm) divided by the plasma insulin concentration (I) during steady-state conditions of the clamp procedure. Units:\[(mg glucose)\*min\*mL\] / \[(kg fat free body mass)\*(micro IU insulin)\]
Outcome measures
| Measure |
Olanzapine
n=41 Participants
Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
|
Risperidone
n=33 Participants
Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
|
|---|---|---|
|
Change in Baseline to Last Observation In Normalized Insulin Sensitivity Index at Low Insulin Phase Using Change in Weight as a Covariate
Baseline
|
0.1664 Mffm/I
Standard Deviation 0.1120
|
0.1937 Mffm/I
Standard Deviation 0.1286
|
|
Change in Baseline to Last Observation In Normalized Insulin Sensitivity Index at Low Insulin Phase Using Change in Weight as a Covariate
Change to Last Observation
|
-0.0149 Mffm/I
Standard Deviation 0.0786
|
-0.0327 Mffm/I
Standard Deviation 0.0829
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations.
Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in weight
Outcome measures
| Measure |
Olanzapine
n=41 Participants
Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
|
Risperidone
n=33 Participants
Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
|
|---|---|---|
|
Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Weight.
|
-0.212 correlation
|
-0.188 correlation
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations.
Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in BMI
Outcome measures
| Measure |
Olanzapine
n=41 Participants
Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
|
Risperidone
n=33 Participants
Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
|
|---|---|---|
|
Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Body Mass Index (BMI)
|
-0.182 correlation
|
-0.195 correlation
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations.
Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in ratio of visceral far area to subcutaneous fat area
Outcome measures
| Measure |
Olanzapine
n=32 Participants
Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
|
Risperidone
n=26 Participants
Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
|
|---|---|---|
|
Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Ratio of Visceral Fat Area to the Subcutaneous Fat Area.
|
-0.055 correlation
|
0.101 correlation
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations.
Normalized insulin senstivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in Brief Psychiatric Rating Scale scores
Outcome measures
| Measure |
Olanzapine
n=41 Participants
Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
|
Risperidone
n=33 Participants
Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
|
|---|---|---|
|
Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Brief Psychiatric Rating Scale Scores.
|
0.035 correlation
|
0.066 correlation
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations.
Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in Clinical Global Impression-Severity of Illness scale scores
Outcome measures
| Measure |
Olanzapine
n=41 Participants
Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
|
Risperidone
n=33 Participants
Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
|
|---|---|---|
|
Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Clinical Global Impression - Severity of Illness Scale Scores.
|
0.068 correlation
|
0.234 correlation
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations.
Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in Abnormal Involuntary Movement Scale scores
Outcome measures
| Measure |
Olanzapine
n=41 Participants
Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
|
Risperidone
n=33 Participants
Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
|
|---|---|---|
|
Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Abnormal Involuntary Movement Scale Scores.
|
0.001 correlation
|
-0.134 correlation
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations.
Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in Barnes Akathisia scores
Outcome measures
| Measure |
Olanzapine
n=41 Participants
Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
|
Risperidone
n=33 Participants
Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
|
|---|---|---|
|
Pairwise Correlation Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Barnes Akathisia Scale Scores.
|
-0.120 correlation
|
0.006 correlation
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations.
Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in the Simpson Angus Scale scores
Outcome measures
| Measure |
Olanzapine
n=41 Participants
Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
|
Risperidone
n=33 Participants
Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
|
|---|---|---|
|
Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in the Simpson Angus Scale Scores.
|
0.184 correlation
|
0.249 correlation
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations
Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in waist circumference
Outcome measures
| Measure |
Olanzapine
n=40 Participants
Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
|
Risperidone
n=29 Participants
Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
|
|---|---|---|
|
Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Waist Circumference.
|
-0.206 correlation
|
-0.263 correlation
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations
Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in visceral fat area
Outcome measures
| Measure |
Olanzapine
n=32 Participants
Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
|
Risperidone
n=27 Participants
Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
|
|---|---|---|
|
Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Visceral Fat Area.
|
-0.048 correlation
|
-0.057 correlation
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations.
Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in subcutaneous fat area
Outcome measures
| Measure |
Olanzapine
n=32 Participants
Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
|
Risperidone
n=27 Participants
Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
|
|---|---|---|
|
Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Subcutaneous Fat Area.
|
-0.043 correlation
|
-0.085 correlation
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations.
Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in Eating Behavior Assessment Scale scores
Outcome measures
| Measure |
Olanzapine
n=41 Participants
Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
|
Risperidone
n=33 Participants
Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
|
|---|---|---|
|
Pairwise Correlations Between Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Eating Behavior Assessment Scale Scores.
Item 1: How Hungry?
|
-0.137 correlation
|
-0.371 correlation
|
|
Pairwise Correlations Between Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Eating Behavior Assessment Scale Scores.
Item 2: How Strong Appetite?
|
-0.137 correlation
|
-0.269 correlation
|
|
Pairwise Correlations Between Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Eating Behavior Assessment Scale Scores.
Item 3: Craved Sweets or Other Carbohydrates?
|
-0.009 correlation
|
0.035 correlation
|
|
Pairwise Correlations Between Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Eating Behavior Assessment Scale Scores.
Item 4: Craved Fatty Foods?
|
-0.068 correlation
|
-0.184 correlation
|
|
Pairwise Correlations Between Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Eating Behavior Assessment Scale Scores.
Item 5: Felt Full or Satisfied After Meal?
|
-0.117 correlation
|
-0.060 correlation
|
|
Pairwise Correlations Between Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Eating Behavior Assessment Scale Scores.
Item 6:Excessive Amount of Food to Feel Satisfied?
|
0.134 correlation
|
0.067 correlation
|
|
Pairwise Correlations Between Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Eating Behavior Assessment Scale Scores.
Item 7: Thinking About Food?
|
-0.172 correlation
|
0.045 correlation
|
|
Pairwise Correlations Between Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Eating Behavior Assessment Scale Scores.
Item 8: Overeating?
|
-0.032 correlation
|
-0.165 correlation
|
|
Pairwise Correlations Between Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Eating Behavior Assessment Scale Scores.
Item 9: Feel Eating is Out of Control?
|
-0.075 correlation
|
-0.354 correlation
|
SECONDARY outcome
Timeframe: baseline and 12 weeksPopulation: Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations
Within-and Between-Treatment Group changes in Body Mass Index from baseline to last observation carried forward.
Outcome measures
| Measure |
Olanzapine
n=41 Participants
Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
|
Risperidone
n=33 Participants
Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
|
|---|---|---|
|
Change From Baseline to 12 Week Endpoint in Body Mass Index
Baseline
|
28.96 kilograms per square meter (kg/m2)
Standard Deviation 5.17
|
28.79 kilograms per square meter (kg/m2)
Standard Deviation 5.40
|
|
Change From Baseline to 12 Week Endpoint in Body Mass Index
Change to Last Observation
|
1.02 kilograms per square meter (kg/m2)
Standard Deviation 1.61
|
0.39 kilograms per square meter (kg/m2)
Standard Deviation 1.15
|
SECONDARY outcome
Timeframe: baseline and 12 weeksPopulation: Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations.
Weight change from baseline to last visit (last observation carried forward)
Outcome measures
| Measure |
Olanzapine
n=41 Participants
Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
|
Risperidone
n=33 Participants
Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
|
|---|---|---|
|
Change From Baseline to 12 Week Endpoint in Weight
Baseline
|
85.93 kilograms
Standard Deviation 17.26
|
86.55 kilograms
Standard Deviation 19.53
|
|
Change From Baseline to 12 Week Endpoint in Weight
Change to Last Observation
|
2.98 kilograms
Standard Deviation 4.82
|
1.23 kilograms
Standard Deviation 4.45
|
SECONDARY outcome
Timeframe: baseline and 12 weeksPopulation: Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations.
Waist circumference change from baseline to last observation carried forward.
Outcome measures
| Measure |
Olanzapine
n=40 Participants
Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
|
Risperidone
n=29 Participants
Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
|
|---|---|---|
|
Change From Baseline to 12 Week Endpoint in Waist Circumference
Baseline
|
99.13 centimeters
Standard Deviation 14.42
|
98.49 centimeters
Standard Deviation 11.60
|
|
Change From Baseline to 12 Week Endpoint in Waist Circumference
Change to Last Observation
|
2.38 centimeters
Standard Deviation 7.46
|
0.17 centimeters
Standard Deviation 4.99
|
SECONDARY outcome
Timeframe: baseline and 12 weeksPopulation: Abdominal CT scan of changes from baseline to last observation of randomized patients who completed baseline and endpoint clamps with both diet stabilizations
Visceral fat area change from baseline to last observation carried forward, all randomized patients, double-blind treatment period
Outcome measures
| Measure |
Olanzapine
n=32 Participants
Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
|
Risperidone
n=27 Participants
Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
|
|---|---|---|
|
Change From Baseline to 12 Week Endpoint in Visceral Fat Area
Baseline
|
101.46 square centimeters (cm2)
Standard Deviation 54.99
|
102.17 square centimeters (cm2)
Standard Deviation 52.61
|
|
Change From Baseline to 12 Week Endpoint in Visceral Fat Area
Change to Last Observation
|
4.70 square centimeters (cm2)
Standard Deviation 21.21
|
8.70 square centimeters (cm2)
Standard Deviation 42.39
|
SECONDARY outcome
Timeframe: baseline and 12 weeksPopulation: Abdominal CT scan change from baseline to last observation for randomized patients who completed baseline and endpoint clamps with both diet stabilizations
Subcutaneous fat area change from baseline to last observation carried forward, all randomized patients, double-blind treatment period
Outcome measures
| Measure |
Olanzapine
n=32 Participants
Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
|
Risperidone
n=27 Participants
Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
|
|---|---|---|
|
Change From Baseline to 12 Week Endpoint in Subcutaneous Fat Area
Baseline
|
281.07 square centimeters (cm2)
Standard Deviation 158.59
|
317.16 square centimeters (cm2)
Standard Deviation 172.19
|
|
Change From Baseline to 12 Week Endpoint in Subcutaneous Fat Area
Change to last observation
|
4.94 square centimeters (cm2)
Standard Deviation 40.36
|
35.15 square centimeters (cm2)
Standard Deviation 105.64
|
SECONDARY outcome
Timeframe: baseline and 12 weeksPopulation: Abdominal CT scan change from baseline to last observation of randomized patients who completed the baseline and endpoint clamps with both diet stabilizations
Ratio of the visceral fat area to the subcutaneous fat area change from baseline to last observation carried forward, all randomized patients, double-blind treatment period
Outcome measures
| Measure |
Olanzapine
n=32 Participants
Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
|
Risperidone
n=26 Participants
Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
|
|---|---|---|
|
Change From Baseline to 12 Week Endpoint in the Ratio of the Visceral Fat Area to the Subcutaneous Fat Area
Baseline
|
0.41 ratio in square centimeters (cm2)
Standard Deviation 0.25
|
0.43 ratio in square centimeters (cm2)
Standard Deviation 0.33
|
|
Change From Baseline to 12 Week Endpoint in the Ratio of the Visceral Fat Area to the Subcutaneous Fat Area
Change to last observation
|
0.01 ratio in square centimeters (cm2)
Standard Deviation 0.12
|
0.00 ratio in square centimeters (cm2)
Standard Deviation 0.14
|
SECONDARY outcome
Timeframe: baseline and 12 weeksPopulation: BPRS Total and Subscale Scores-Change from Baseline to Last Observation Carried Forward, all randomized patients, double-blind treatment period
Brief Psychiatric Rating Scale (BPRS) is an 18-item clinician-administered scale used to assess the degree of severity of a subject's general psychopathological symptoms. Item scores range from 0 (not present) to 6 (extremely severe). Total Scores range from 0 to 108; Positive Subscale Scores range from 0 to 24. Negative Subscale Scores range from 0 to 18. Anxiety-Depression Subscale Scores range from 0 to 24.
Outcome measures
| Measure |
Olanzapine
n=60 Participants
Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
|
Risperidone
n=56 Participants
Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
|
|---|---|---|
|
Change From Baseline to 12 Week Endpoint in Brief Psychiatric Rating Scale (BPRS) Scores
Negative Subscale Score Baseline
|
2.32 units on a scale
Standard Deviation 2.04
|
1.88 units on a scale
Standard Deviation 1.83
|
|
Change From Baseline to 12 Week Endpoint in Brief Psychiatric Rating Scale (BPRS) Scores
Total Score Baseline
|
13.32 units on a scale
Standard Deviation 6.26
|
13.96 units on a scale
Standard Deviation 6.02
|
|
Change From Baseline to 12 Week Endpoint in Brief Psychiatric Rating Scale (BPRS) Scores
Total Score Change to Last Observation
|
-1.98 units on a scale
Standard Deviation 6.30
|
-1.48 units on a scale
Standard Deviation 7.99
|
|
Change From Baseline to 12 Week Endpoint in Brief Psychiatric Rating Scale (BPRS) Scores
Positive Subscale Score Baseline
|
5.22 units on a scale
Standard Deviation 2.75
|
5.27 units on a scale
Standard Deviation 2.51
|
|
Change From Baseline to 12 Week Endpoint in Brief Psychiatric Rating Scale (BPRS) Scores
Positive Subscale Score Change to Last Observation
|
-0.82 units on a scale
Standard Deviation 2.81
|
-1.20 units on a scale
Standard Deviation 3.08
|
|
Change From Baseline to 12 Week Endpoint in Brief Psychiatric Rating Scale (BPRS) Scores
Negative Subscale Score Change to Last Observation
|
-0.38 units on a scale
Standard Deviation 1.58
|
-0.02 units on a scale
Standard Deviation 1.99
|
|
Change From Baseline to 12 Week Endpoint in Brief Psychiatric Rating Scale (BPRS) Scores
Anxiety-Depression Baseline
|
4.33 units on a scale
Standard Deviation 2.59
|
3.73 units on a scale
Standard Deviation 2.18
|
|
Change From Baseline to 12 Week Endpoint in Brief Psychiatric Rating Scale (BPRS) Scores
Anxiety-Depression Change to Last Observation
|
-0.78 units on a scale
Standard Deviation 2.29
|
-0.32 units on a scale
Standard Deviation 2.50
|
SECONDARY outcome
Timeframe: baseline and 12 weeksPopulation: Change from baseline to last observation carried forward, all randomized patients, double-blind treatment period
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.
Outcome measures
| Measure |
Olanzapine
n=60 Participants
Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
|
Risperidone
n=56 Participants
Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
|
|---|---|---|
|
Change From Baseline to 12 Week Endpoint in Clinical Global Impression - Severity of Illness Scores
Baseline
|
3.65 units on a scale
Standard Deviation 0.55
|
3.61 units on a scale
Standard Deviation 0.53
|
|
Change From Baseline to 12 Week Endpoint in Clinical Global Impression - Severity of Illness Scores
Change to last observation
|
-0.22 units on a scale
Standard Deviation 0.58
|
-0.23 units on a scale
Standard Deviation 0.66
|
SECONDARY outcome
Timeframe: baseline and 12 weeksPopulation: Change from baseline to last observation carried forward, all randomized patients, double-blind treatment period
A 12-item instrument assesses observed abnormal movements in different parts of body. Seven items are scored in a 5-point scale (0 = none/normal, 4 = severe) which evaluates abnormal movements in 3 main anatomic areas (orofacial area, extremities, and trunk). Total scores range from 0 to 28. Five collected elements are not used in this total.
Outcome measures
| Measure |
Olanzapine
n=54 Participants
Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
|
Risperidone
n=47 Participants
Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
|
|---|---|---|
|
Change From Baseline to 12 Week Endpoint in Abnormal Involuntary Movement Scale Scores
Baseline
|
0.48 units on a scale
Standard Deviation 1.24
|
0.53 units on a scale
Standard Deviation 1.25
|
|
Change From Baseline to 12 Week Endpoint in Abnormal Involuntary Movement Scale Scores
Change to last observation
|
0.04 units on a scale
Standard Deviation 1.15
|
0.04 units on a scale
Standard Deviation 1.35
|
SECONDARY outcome
Timeframe: baseline and 12 weeksPopulation: Change from baseline to last observation carried forward, all randomized patients, double-blind treatment period
The BARS is a 4-item instrument that evaluates akathisia associated with use of antipsychotic medications. Item 4 is the Global clinical assessment and is rated 0 to 5 (0 = absent, 5 = severe). The other 3 items (related to objective and subjective assessments) are not used for these analyses.
Outcome measures
| Measure |
Olanzapine
n=54 Participants
Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
|
Risperidone
n=47 Participants
Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
|
|---|---|---|
|
Change From Baseline to 12 Week Endpoint in Barnes Akathisia Rating Scale (BARS) Scores
Change to last observation
|
0.02 units on a scale
Standard Deviation 0.84
|
-0.02 units on a scale
Standard Deviation 0.82
|
|
Change From Baseline to 12 Week Endpoint in Barnes Akathisia Rating Scale (BARS) Scores
Baseline
|
0.24 units on a scale
Standard Deviation 0.64
|
0.36 units on a scale
Standard Deviation 0.70
|
SECONDARY outcome
Timeframe: baseline and 12 weeksPopulation: Change from baseline to last observation carried forward, all randomized patients, double-blind treatment period
Measures neuroleptic-induced parkinsonism. Total score of Simpson Angus Scale consists of the sum of 10 items rated on a 5-point severity scale where 0=normal and 4=extreme. The total score ranges from 0 to 40.
Outcome measures
| Measure |
Olanzapine
n=54 Participants
Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
|
Risperidone
n=47 Participants
Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
|
|---|---|---|
|
Change From Baseline to 12 Week Endpoint in Simpson Angus Scale Scores
Baseline
|
1.13 units on a scale
Standard Deviation 2.02
|
0.94 units on a scale
Standard Deviation 1.79
|
|
Change From Baseline to 12 Week Endpoint in Simpson Angus Scale Scores
Change to last observation
|
-0.06 units on a scale
Standard Deviation 1.48
|
0.30 units on a scale
Standard Deviation 1.92
|
SECONDARY outcome
Timeframe: baseline and 12 weeksPopulation: Change from baseline to last observation carried forward, all randomized patients, double-blind treatment period
Eating Behavior Assessment Scale is a 9-item self-rated tool used to evaluate appetite and eating behaviors. Item scores range from 0 (never) to 4 (always).
Outcome measures
| Measure |
Olanzapine
n=59 Participants
Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
|
Risperidone
n=53 Participants
Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
|
|---|---|---|
|
Change From Baseline to 12 Week Endpoint in Eating Behavior Assessment Scale Scores
Item 1 Baseline (How Hungry?)
|
1.42 units on a scale
Standard Deviation 1.09
|
1.32 units on a scale
Standard Deviation 0.94
|
|
Change From Baseline to 12 Week Endpoint in Eating Behavior Assessment Scale Scores
Item 1 Change to Last Observation
|
0.25 units on a scale
Standard Deviation 1.27
|
0.42 units on a scale
Standard Deviation 1.18
|
|
Change From Baseline to 12 Week Endpoint in Eating Behavior Assessment Scale Scores
Item 2 Baseline (How Strong Appetite?)
|
1.54 units on a scale
Standard Deviation 1.10
|
1.32 units on a scale
Standard Deviation 1.03
|
|
Change From Baseline to 12 Week Endpoint in Eating Behavior Assessment Scale Scores
Item 2 Change to Last Observation
|
0.17 units on a scale
Standard Deviation 1.26
|
0.38 units on a scale
Standard Deviation 1.33
|
|
Change From Baseline to 12 Week Endpoint in Eating Behavior Assessment Scale Scores
Item 3 Baseline (Craved Sweets or Other Carbos?)
|
1.00 units on a scale
Standard Deviation 1.17
|
0.83 units on a scale
Standard Deviation 1.10
|
|
Change From Baseline to 12 Week Endpoint in Eating Behavior Assessment Scale Scores
Item 3 Change to Last Observation
|
0.19 units on a scale
Standard Deviation 1.47
|
0.36 units on a scale
Standard Deviation 1.18
|
|
Change From Baseline to 12 Week Endpoint in Eating Behavior Assessment Scale Scores
Item 4 Baseline (Craved Fatty Foods?)
|
0.80 units on a scale
Standard Deviation 1.01
|
0.74 units on a scale
Standard Deviation 1.00
|
|
Change From Baseline to 12 Week Endpoint in Eating Behavior Assessment Scale Scores
Item 4 Change to Last Observation
|
0.31 units on a scale
Standard Deviation 1.52
|
0.25 units on a scale
Standard Deviation 1.05
|
|
Change From Baseline to 12 Week Endpoint in Eating Behavior Assessment Scale Scores
Item 5 Baseline (Felt Full After Meal?)
|
2.59 units on a scale
Standard Deviation 0.93
|
2.55 units on a scale
Standard Deviation 0.89
|
|
Change From Baseline to 12 Week Endpoint in Eating Behavior Assessment Scale Scores
Item 5 Change to Last Observation
|
-0.17 units on a scale
Standard Deviation 1.15
|
0.00 units on a scale
Standard Deviation 1.19
|
|
Change From Baseline to 12 Week Endpoint in Eating Behavior Assessment Scale Scores
Item 6 Baseline(Excessive Food to Feel Satisfied?)
|
0.86 units on a scale
Standard Deviation 1.21
|
0.79 units on a scale
Standard Deviation 1.12
|
|
Change From Baseline to 12 Week Endpoint in Eating Behavior Assessment Scale Scores
Item 6 Change to Last Observation
|
0.17 units on a scale
Standard Deviation 1.40
|
0.28 units on a scale
Standard Deviation 1.25
|
|
Change From Baseline to 12 Week Endpoint in Eating Behavior Assessment Scale Scores
Item 7 Baseline (Thinking About Food?)
|
0.90 units on a scale
Standard Deviation 1.18
|
0.77 units on a scale
Standard Deviation 1.14
|
|
Change From Baseline to 12 Week Endpoint in Eating Behavior Assessment Scale Scores
Item 7 Change to Last Observation
|
0.12 units on a scale
Standard Deviation 1.31
|
0.13 units on a scale
Standard Deviation 1.36
|
|
Change From Baseline to 12 Week Endpoint in Eating Behavior Assessment Scale Scores
Item 8 Baseline (Overeating?)
|
0.42 units on a scale
Standard Deviation 0.95
|
0.53 units on a scale
Standard Deviation 1.08
|
|
Change From Baseline to 12 Week Endpoint in Eating Behavior Assessment Scale Scores
Item 8 Change to Last Observation
|
0.17 units on a scale
Standard Deviation 1.33
|
0.15 units on a scale
Standard Deviation 1.31
|
|
Change From Baseline to 12 Week Endpoint in Eating Behavior Assessment Scale Scores
Item 9 Baseline (Feel Eating is Out of Control?)
|
0.10 units on a scale
Standard Deviation 0.36
|
0.26 units on a scale
Standard Deviation 0.76
|
|
Change From Baseline to 12 Week Endpoint in Eating Behavior Assessment Scale Scores
Item 9 Change to Last Observation
|
0.25 units on a scale
Standard Deviation 0.94
|
0.11 units on a scale
Standard Deviation 1.01
|
SECONDARY outcome
Timeframe: baseline and 12 weeksPopulation: Change from baseline to last observation, all randomized patients, double-blind treatment period
Fasting lipid parameters including total cholesterol, change from baseline to last observation carried forward.
Outcome measures
| Measure |
Olanzapine
n=51 Participants
Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
|
Risperidone
n=49 Participants
Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
|
|---|---|---|
|
Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Total Cholesterol
Baseline
|
4.91 millimoles per Liter (mmol/L)
Standard Deviation 1.06
|
4.97 millimoles per Liter (mmol/L)
Standard Deviation 1.12
|
|
Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Total Cholesterol
Change to Last Observation
|
0.18 millimoles per Liter (mmol/L)
Standard Deviation 0.89
|
0.01 millimoles per Liter (mmol/L)
Standard Deviation 0.79
|
SECONDARY outcome
Timeframe: baseline and 12 weeksPopulation: Change from baseline to last observation, all randomized patients, double-blind treatment period
Fasting lipid parameters including Direct LDL, change from baseline to last observation carried forward.
Outcome measures
| Measure |
Olanzapine
n=51 Participants
Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
|
Risperidone
n=49 Participants
Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
|
|---|---|---|
|
Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Direct Low Density Lipoprotein (LDL)
Baseline
|
3.18 millimoles per Liter (mmol/L)
Standard Deviation 0.90
|
3.11 millimoles per Liter (mmol/L)
Standard Deviation 0.99
|
|
Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Direct Low Density Lipoprotein (LDL)
Change to last observation
|
-0.03 millimoles per Liter (mmol/L)
Standard Deviation 0.67
|
-0.02 millimoles per Liter (mmol/L)
Standard Deviation 0.63
|
SECONDARY outcome
Timeframe: baseline and 12 weeksPopulation: Change from baseline to last observation, all randomized patients, double-blind treatment period
Fasting lipid parameters including HDL change from baseline to last observation carried forward.
Outcome measures
| Measure |
Olanzapine
n=51 Participants
Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
|
Risperidone
n=48 Participants
Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
|
|---|---|---|
|
Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including High Density Lipoprotein (HDL)
Baseline
|
1.08 millimoles per Liter (mmol/L)
Standard Deviation 0.25
|
1.18 millimoles per Liter (mmol/L)
Standard Deviation 0.32
|
|
Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including High Density Lipoprotein (HDL)
Change to last observation
|
0.06 millimoles per Liter (mmol/L)
Standard Deviation 0.24
|
0.05 millimoles per Liter (mmol/L)
Standard Deviation 0.27
|
SECONDARY outcome
Timeframe: baseline and 12 weeksPopulation: Change from baseline to last observation, all randomized patients, double-blind treatment period
Changes in fasting lipid parameters including triglycerides last observation carried forward (LOCF) mean change from baseline
Outcome measures
| Measure |
Olanzapine
n=51 Participants
Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
|
Risperidone
n=49 Participants
Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
|
|---|---|---|
|
Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Triglycerides
Baseline
|
1.68 millimoles per Liter (mmol/L)
Standard Deviation 0.91
|
1.55 millimoles per Liter (mmol/L)
Standard Deviation 0.85
|
|
Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Triglycerides
Change to Last Observation
|
0.34 millimoles per Liter (mmol/L)
Standard Deviation 1.12
|
-0.10 millimoles per Liter (mmol/L)
Standard Deviation 0.74
|
SECONDARY outcome
Timeframe: baseline and 12 weeks.Population: Mean change from baseline, all randomized patients, double-blind treatment period
Changes in lipid parameters and subclass lipoproteins last observation carried forward (LOCF) mean change from baseline. HDL=High Density Lipoprotein, IDL=Intermdiate Density Lipoprotein, LDL=Low Density Lipoprotein, VLDL=Very Low Density Lipoprotein.
Outcome measures
| Measure |
Olanzapine
n=40 Participants
Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
|
Risperidone
n=32 Participants
Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
|
|---|---|---|
|
Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Lipoprotein Subclasses
HDL particles, total, baseline
|
28.39 nanomoles per Liter (nmol/L)
Standard Deviation 5.38
|
29.81 nanomoles per Liter (nmol/L)
Standard Deviation 5.29
|
|
Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Lipoprotein Subclasses
HDL particles, total, change to last observation
|
1.71 nanomoles per Liter (nmol/L)
Standard Deviation 4.84
|
-1.09 nanomoles per Liter (nmol/L)
Standard Deviation 4.34
|
|
Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Lipoprotein Subclasses
IDL, baseline
|
53.18 nanomoles per Liter (nmol/L)
Standard Deviation 55.32
|
52.56 nanomoles per Liter (nmol/L)
Standard Deviation 61.38
|
|
Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Lipoprotein Subclasses
IDL, change to last observation
|
21.40 nanomoles per Liter (nmol/L)
Standard Deviation 59.63
|
-2.69 nanomoles per Liter (nmol/L)
Standard Deviation 46.07
|
|
Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Lipoprotein Subclasses
Medium small LDL, baseline
|
175.15 nanomoles per Liter (nmol/L)
Standard Deviation 98.59
|
197.00 nanomoles per Liter (nmol/L)
Standard Deviation 116.28
|
|
Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Lipoprotein Subclasses
Medium small LDL, change to last observation
|
35.70 nanomoles per Liter (nmol/L)
Standard Deviation 52.40
|
-11.47 nanomoles per Liter (nmol/L)
Standard Deviation 84.73
|
|
Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Lipoprotein Subclasses
Small LDL, baseline
|
878.68 nanomoles per Liter (nmol/L)
Standard Deviation 481.65
|
977.84 nanomoles per Liter (nmol/L)
Standard Deviation 622.99
|
|
Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Lipoprotein Subclasses
Small LDL, change to last observation
|
128.55 nanomoles per Liter (nmol/L)
Standard Deviation 236.89
|
-74.09 nanomoles per Liter (nmol/L)
Standard Deviation 428.13
|
|
Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Lipoprotein Subclasses
Very small LDL, baseline
|
703.63 nanomoles per Liter (nmol/L)
Standard Deviation 385.31
|
780.78 nanomoles per Liter (nmol/L)
Standard Deviation 508.24
|
|
Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Lipoprotein Subclasses
Very small LDL, change to last observation
|
92.75 nanomoles per Liter (nmol/L)
Standard Deviation 193.00
|
-62.50 nanomoles per Liter (nmol/L)
Standard Deviation 347.08
|
|
Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Lipoprotein Subclasses
VLDL mean particle size, baseline
|
51.21 nanomoles per Liter (nmol/L)
Standard Deviation 8.57
|
51.05 nanomoles per Liter (nmol/L)
Standard Deviation 11.83
|
|
Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Lipoprotein Subclasses
VLDL mean particle size, change to last observ.
|
4.09 nanomoles per Liter (nmol/L)
Standard Deviation 7.83
|
1.80 nanomoles per Liter (nmol/L)
Standard Deviation 9.21
|
Adverse Events
Olanzapine
Risperidone
Serious adverse events
| Measure |
Olanzapine
n=68 participants at risk
Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
|
Risperidone
n=62 participants at risk
Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
|
|---|---|---|
|
Immune system disorders
Asthma
|
0.00%
0/68
|
1.6%
1/62 • Number of events 1
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/68
|
1.6%
1/62 • Number of events 1
|
|
Psychiatric disorders
Schizoaffective disorder
|
1.5%
1/68 • Number of events 1
|
1.6%
1/62 • Number of events 2
|
|
Psychiatric disorders
Schizophrenia
|
1.5%
1/68 • Number of events 1
|
0.00%
0/62
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/68
|
1.6%
1/62 • Number of events 1
|
|
Vascular disorders
Hypotension
|
0.00%
0/68
|
1.6%
1/62 • Number of events 1
|
Other adverse events
| Measure |
Olanzapine
n=68 participants at risk
Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
|
Risperidone
n=62 participants at risk
Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
5.9%
4/68 • Number of events 4
|
1.6%
1/62 • Number of events 1
|
|
Gastrointestinal disorders
Dry mouth
|
7.4%
5/68 • Number of events 5
|
8.1%
5/62 • Number of events 6
|
|
General disorders
Discomfort
|
7.4%
5/68 • Number of events 5
|
3.2%
2/62 • Number of events 2
|
|
Investigations
Weight increased
|
16.2%
11/68 • Number of events 11
|
6.5%
4/62 • Number of events 4
|
|
Metabolism and nutrition disorders
Increased appetite
|
7.4%
5/68 • Number of events 5
|
11.3%
7/62 • Number of events 7
|
|
Nervous system disorders
Headache
|
10.3%
7/68 • Number of events 9
|
12.9%
8/62 • Number of events 12
|
|
Nervous system disorders
Sedation
|
10.3%
7/68 • Number of events 8
|
6.5%
4/62 • Number of events 5
|
|
Psychiatric disorders
Anxiety
|
1.5%
1/68 • Number of events 1
|
9.7%
6/62 • Number of events 6
|
|
Psychiatric disorders
Insomnia
|
5.9%
4/68 • Number of events 5
|
11.3%
7/62 • Number of events 7
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60