Trial Outcomes & Findings for A Comparison of Olanzapine in Combination With a Mood Stabilizer vs Mood Stabilizer Alone, in Mixed Bipolar Patients (NCT NCT00402324)
NCT ID: NCT00402324
Last Updated: 2009-06-03
Results Overview
The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
202 participants
Primary outcome timeframe
Baseline to endpoint (6 weeks)
Results posted on
2009-06-03
Participant Flow
Study Period 1 was a 2-28 day day period allowing for screening, divalproex treatment initiation (if appropriate) and washout. Patients meeting diagnostic criteria and having therapeutic serum levels of divalproex in target range of 75 to 125 µg/mL (≥80 µg/mL recommended) during Study Period I, will be randomized into either placebo or olanzapine.
Participant milestones
| Measure |
Olanzapine
Olanzapine: 15mg, capsules, by mouth every evening, daily for minimum of one day, followed by 5-20mg, capsules, by mouth every evening, daily for remainder of study (6 weeks total).
Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
|
Placebo
Placebo: placebo capsules, by mouth every evening, daily, for 6 weeks. Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
|
|---|---|---|
|
Overall Study
STARTED
|
101
|
101
|
|
Overall Study
COMPLETED
|
58
|
60
|
|
Overall Study
NOT COMPLETED
|
43
|
41
|
Reasons for withdrawal
| Measure |
Olanzapine
Olanzapine: 15mg, capsules, by mouth every evening, daily for minimum of one day, followed by 5-20mg, capsules, by mouth every evening, daily for remainder of study (6 weeks total).
Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
|
Placebo
Placebo: placebo capsules, by mouth every evening, daily, for 6 weeks. Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
11
|
11
|
|
Overall Study
Protocol Entry Criteria Not Met
|
5
|
4
|
|
Overall Study
Protocol Violation
|
8
|
7
|
|
Overall Study
Withdrawal by Subject
|
5
|
2
|
|
Overall Study
Physician Decision
|
2
|
4
|
|
Overall Study
Sponsor Decision
|
4
|
5
|
|
Overall Study
Lack of Efficacy
|
1
|
4
|
|
Overall Study
Adverse Event
|
6
|
4
|
|
Overall Study
Death
|
1
|
0
|
Baseline Characteristics
A Comparison of Olanzapine in Combination With a Mood Stabilizer vs Mood Stabilizer Alone, in Mixed Bipolar Patients
Baseline characteristics by cohort
| Measure |
Olanzapine
n=101 Participants
Olanzapine: 15mg, capsules, by mouth every evening, daily for minimum of one day, followed by 5-20mg, capsules, by mouth every evening, daily for remainder of study (6 weeks total).
Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
|
Placebo
n=101 Participants
Placebo: placebo capsules, by mouth every evening, daily, for 6 weeks. Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
|
Total
n=202 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
38.61 years
STANDARD_DEVIATION 11.20 • n=5 Participants
|
38.52 years
STANDARD_DEVIATION 11.07 • n=7 Participants
|
38.56 years
STANDARD_DEVIATION 11.11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
61 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
119 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
101 participants
n=5 Participants
|
101 participants
n=7 Participants
|
202 participants
n=5 Participants
|
|
Race/Ethnicity
Caucasian
|
46 participants
n=5 Participants
|
56 participants
n=7 Participants
|
102 participants
n=5 Participants
|
|
Race/Ethnicity
African Descent
|
38 participants
n=5 Participants
|
29 participants
n=7 Participants
|
67 participants
n=5 Participants
|
|
Race/Ethnicity
Hispanic
|
15 participants
n=5 Participants
|
13 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
Race/Ethnicity
Native American
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Race/Ethnicity
East Asian
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
30.73 kilograms per square meters
STANDARD_DEVIATION 8.99 • n=5 Participants
|
31.72 kilograms per square meters
STANDARD_DEVIATION 8.29 • n=7 Participants
|
31.23 kilograms per square meters
STANDARD_DEVIATION 8.64 • n=5 Participants
|
|
Body Weight
|
87.33 kilograms
STANDARD_DEVIATION 24.17 • n=5 Participants
|
90.75 kilograms
STANDARD_DEVIATION 23.70 • n=7 Participants
|
89.04 kilograms
STANDARD_DEVIATION 23.94 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to endpoint (6 weeks)Population: Intent to Treat analysis. All randomized patients with baseline \& at least one post-baseline measure.
The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60.
Outcome measures
| Measure |
Olanzapine
n=100 Participants
Olanzapine: 15mg, capsules, by mouth every evening, daily for minimum of one day, followed by 5-20mg, capsules, by mouth every evening, daily for remainder of study (6 weeks total).
Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
|
Placebo
n=101 Participants
Placebo: placebo capsules, by mouth every evening, daily, for 6 weeks. Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
|
|---|---|---|
|
Mean Change in Young Mania Rating Scale (YMRS) Scores From Baseline to Endpoint.
|
-10.15 units on a scale
Standard Error 0.44
|
-7.68 units on a scale
Standard Error 0.44
|
PRIMARY outcome
Timeframe: Baseline to endpoint (6 weeks)Population: Intent to Treat analysis. All randomized patients with baseline \& at least one post-baseline measure.
The 21-item HAMD measures depression severity. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 60.
Outcome measures
| Measure |
Olanzapine
n=100 Participants
Olanzapine: 15mg, capsules, by mouth every evening, daily for minimum of one day, followed by 5-20mg, capsules, by mouth every evening, daily for remainder of study (6 weeks total).
Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
|
Placebo
n=101 Participants
Placebo: placebo capsules, by mouth every evening, daily, for 6 weeks. Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
|
|---|---|---|
|
Mean Change in Hamilton Depression Rating Scale-21 (HAMD) Scores From Baseline to Endpoint.
|
-9.37 units on a scale
Standard Error 0.55
|
-7.69 units on a scale
Standard Error 0.54
|
SECONDARY outcome
Timeframe: Baseline to endpoint (6 weeks)Population: All randomized participants with both baseline and post-baseline measures. Intention to Treat analysis.
The original outcome measure was Time to Mixed Onset of Action (at least a 25% reduction on HAMD and YMRS total scores from baseline); however since upper limit of measure of dispersion could not be computed by observed data, which is not allowed on this system, number of patients with event are presented instead.
Outcome measures
| Measure |
Olanzapine
n=100 Participants
Olanzapine: 15mg, capsules, by mouth every evening, daily for minimum of one day, followed by 5-20mg, capsules, by mouth every evening, daily for remainder of study (6 weeks total).
Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
|
Placebo
n=101 Participants
Placebo: placebo capsules, by mouth every evening, daily, for 6 weeks. Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
|
|---|---|---|
|
Number of Participants Meeting the Criteria for Mixed Onset of Action
|
81 participants
Interval 3.0 to 15.0
|
71 participants
Interval 4.0 to 45.0
|
SECONDARY outcome
Timeframe: baseline to endpoint (6 weeks)Population: All randomized participants with both baseline and post-baseline measures. Intention to Treat analysis.
The original outcome measure was Time to Mixed Response(at least a 50% reduction on HAMD and YMRS total scores from baseline); however since upper limit of measure of dispersion could not be computed by observed data, which is not allowed on this system, number of patients with event are presented instead.
Outcome measures
| Measure |
Olanzapine
n=100 Participants
Olanzapine: 15mg, capsules, by mouth every evening, daily for minimum of one day, followed by 5-20mg, capsules, by mouth every evening, daily for remainder of study (6 weeks total).
Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
|
Placebo
n=101 Participants
Placebo: placebo capsules, by mouth every evening, daily, for 6 weeks. Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
|
|---|---|---|
|
Number of Participants Meeting the Criteria for Mixed Response
|
54 participants
Interval 9.0 to
|
40 participants
Interval 13.0 to
|
SECONDARY outcome
Timeframe: Baseline to endpoint (6 weeks)Population: Intent to Treat analysis. Number of randomized patients with baseline and at least one nonmissing postbaseline value. Last observation carried forward.
CGI-BP Severity is used by the clinician to record the severity of illness at the time of assessment. The score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
Outcome measures
| Measure |
Olanzapine
n=100 Participants
Olanzapine: 15mg, capsules, by mouth every evening, daily for minimum of one day, followed by 5-20mg, capsules, by mouth every evening, daily for remainder of study (6 weeks total).
Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
|
Placebo
n=101 Participants
Placebo: placebo capsules, by mouth every evening, daily, for 6 weeks. Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
|
|---|---|---|
|
Mean Change in Clinical Global Impression for Bipolar Illness Severity (CGI-BP) From Baseline to Endpoint
|
-1.34 units on a scale
Standard Error 0.11
|
-1.06 units on a scale
Standard Error 0.11
|
SECONDARY outcome
Timeframe: Baseline to endpoint (6 weeks)Population: Intent to Treat analysis. All randomized patients.
Number of participants hospitalized as a result of relapse of mania or depression.
Outcome measures
| Measure |
Olanzapine
n=101 Participants
Olanzapine: 15mg, capsules, by mouth every evening, daily for minimum of one day, followed by 5-20mg, capsules, by mouth every evening, daily for remainder of study (6 weeks total).
Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
|
Placebo
n=101 Participants
Placebo: placebo capsules, by mouth every evening, daily, for 6 weeks. Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
|
|---|---|---|
|
Number of Patients Hospitalized Due to Relapse of Mania or Depression.
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline to endpoint (6 weeks)Population: All randomized participants with both baseline and at least one post-baseline measure. Intention to Treat analysis.
Change from Baseline to endpoint in cholesterol: value of cholesterol measure at endpoint minus the value at baseline.
Outcome measures
| Measure |
Olanzapine
n=62 Participants
Olanzapine: 15mg, capsules, by mouth every evening, daily for minimum of one day, followed by 5-20mg, capsules, by mouth every evening, daily for remainder of study (6 weeks total).
Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
|
Placebo
n=68 Participants
Placebo: placebo capsules, by mouth every evening, daily, for 6 weeks. Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
|
|---|---|---|
|
Clinically Significant Laboratory Values - Fasting Cholesterol Change From Baseline
Total Cholesterol Baseline
|
191.37 milligrams per deciliter
Standard Deviation 41.23
|
192.25 milligrams per deciliter
Standard Deviation 44.45
|
|
Clinically Significant Laboratory Values - Fasting Cholesterol Change From Baseline
Total Cholesterol Change from Baseline
|
-7.80 milligrams per deciliter
Standard Deviation 31.77
|
-8.72 milligrams per deciliter
Standard Deviation 28.80
|
|
Clinically Significant Laboratory Values - Fasting Cholesterol Change From Baseline
Low Density Lipoprotein Baseline (N=62,N=64)
|
115.32 milligrams per deciliter
Standard Deviation 38.82
|
111.01 milligrams per deciliter
Standard Deviation 36.74
|
|
Clinically Significant Laboratory Values - Fasting Cholesterol Change From Baseline
Low Density Lipoprotein Change (N=62,N=64)
|
-9.22 milligrams per deciliter
Standard Deviation 27.31
|
-9.77 milligrams per deciliter
Standard Deviation 28.05
|
|
Clinically Significant Laboratory Values - Fasting Cholesterol Change From Baseline
High Density Lipoprotein Baseline
|
53.76 milligrams per deciliter
Standard Deviation 12.03
|
51.48 milligrams per deciliter
Standard Deviation 11.64
|
|
Clinically Significant Laboratory Values - Fasting Cholesterol Change From Baseline
High Density Lipoprotein Change from Baseline
|
-3.24 milligrams per deciliter
Standard Deviation 10.02
|
-1.22 milligrams per deciliter
Standard Deviation 8.90
|
SECONDARY outcome
Timeframe: Baseline to endpoint (6 weeks)Population: All randomized participants with both baseline and post-baseline measures. Intention to Treat analysis.
Change from baseline to endpoint in triglycerides: Value of triglyceride measure at endpoint minus value at baseline.
Outcome measures
| Measure |
Olanzapine
n=62 Participants
Olanzapine: 15mg, capsules, by mouth every evening, daily for minimum of one day, followed by 5-20mg, capsules, by mouth every evening, daily for remainder of study (6 weeks total).
Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
|
Placebo
n=68 Participants
Placebo: placebo capsules, by mouth every evening, daily, for 6 weeks. Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
|
|---|---|---|
|
Clinically Significant Laboratory Values - Fasting Triglycerides Change From Baseline
Baseline
|
111.46 milligrams per deciliter
Standard Deviation 61.54
|
139.75 milligrams per deciliter
Standard Deviation 77.22
|
|
Clinically Significant Laboratory Values - Fasting Triglycerides Change From Baseline
Change from Baseline
|
22.91 milligrams per deciliter
Standard Deviation 67.70
|
16.80 milligrams per deciliter
Standard Deviation 73.25
|
SECONDARY outcome
Timeframe: Baseline to endpoint (6 weeks)Population: All randomized participants with both baseline and post-baseline measures. Intention to Treat analysis.
Change from baseline to endpoint in fasting blood glucose: Value of fasting blood glucose measure at endpoint minus value at baseline.
Outcome measures
| Measure |
Olanzapine
n=77 Participants
Olanzapine: 15mg, capsules, by mouth every evening, daily for minimum of one day, followed by 5-20mg, capsules, by mouth every evening, daily for remainder of study (6 weeks total).
Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
|
Placebo
n=82 Participants
Placebo: placebo capsules, by mouth every evening, daily, for 6 weeks. Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
|
|---|---|---|
|
Clinically Significant Laboratory Values - Fasting Blood Glucose Change From Baseline
Baseline
|
91.81 milligrams per deciliter
Standard Deviation 11.98
|
91.90 milligrams per deciliter
Standard Deviation 10.13
|
|
Clinically Significant Laboratory Values - Fasting Blood Glucose Change From Baseline
Change from Baseline
|
6.93 milligrams per deciliter
Standard Deviation 23.72
|
-0.55 milligrams per deciliter
Standard Deviation 14.00
|
SECONDARY outcome
Timeframe: Baseline to endpoint (6 weeks)Population: All randomized participants with both baseline and post-baseline measures. Intention to Treat analysis.
Change from baseline to endpoint in bilirubin total: Value of bilirubin total measure at endpoint minus value at baseline.
Outcome measures
| Measure |
Olanzapine
n=82 Participants
Olanzapine: 15mg, capsules, by mouth every evening, daily for minimum of one day, followed by 5-20mg, capsules, by mouth every evening, daily for remainder of study (6 weeks total).
Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
|
Placebo
n=84 Participants
Placebo: placebo capsules, by mouth every evening, daily, for 6 weeks. Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
|
|---|---|---|
|
Clinically Significant Laboratory Values - Bilirubin Total Change From Baseline
Baseline
|
6.50 micromoles per Liter
Standard Deviation 3.46
|
6.65 micromoles per Liter
Standard Deviation 3.43
|
|
Clinically Significant Laboratory Values - Bilirubin Total Change From Baseline
Change from Baseline
|
-1.56 micromoles per Liter
Standard Deviation 2.99
|
-0.74 micromoles per Liter
Standard Deviation 3.03
|
SECONDARY outcome
Timeframe: Baseline to endpoint (6 weeks)Population: All randomized participants with both baseline and post-baseline measures. Intention to Treat analysis.
Change from baseline to endpoint in body mass index (an estimate of body fat derived by dividing body weight by height squared): Value of body mass index measure at endpoint minus value at baseline.
Outcome measures
| Measure |
Olanzapine
n=100 Participants
Olanzapine: 15mg, capsules, by mouth every evening, daily for minimum of one day, followed by 5-20mg, capsules, by mouth every evening, daily for remainder of study (6 weeks total).
Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
|
Placebo
n=101 Participants
Placebo: placebo capsules, by mouth every evening, daily, for 6 weeks. Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
|
|---|---|---|
|
Clinically Significant Vital Signs - Body Mass Index Change From Baseline
|
1.18 kilograms per square meters
Standard Error 0.12
|
0.26 kilograms per square meters
Standard Error 0.12
|
SECONDARY outcome
Timeframe: Baseline to endpoint (6 weeks)Population: All randomized participants with both baseline and post-baseline measures. Intention to Treat analysis.
Change from baseline to endpoint: Value of weight measure at endpoint minus value at baseline.
Outcome measures
| Measure |
Olanzapine
n=100 Participants
Olanzapine: 15mg, capsules, by mouth every evening, daily for minimum of one day, followed by 5-20mg, capsules, by mouth every evening, daily for remainder of study (6 weeks total).
Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
|
Placebo
n=101 Participants
Placebo: placebo capsules, by mouth every evening, daily, for 6 weeks. Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
|
|---|---|---|
|
Clinically Significant Vital Signs - Weight Change From Baseline
|
3.34 kilograms
Standard Error 0.34
|
0.70 kilograms
Standard Error 0.34
|
SECONDARY outcome
Timeframe: Baseline to endpoint (6 weeks)Population: All randomized participants with both baseline and post-baseline measures. Intention to Treat analysis.
Percentages of participants in each group who experienced an increase in weight of at least 7% from baseline to endpoint.
Outcome measures
| Measure |
Olanzapine
n=100 Participants
Olanzapine: 15mg, capsules, by mouth every evening, daily for minimum of one day, followed by 5-20mg, capsules, by mouth every evening, daily for remainder of study (6 weeks total).
Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
|
Placebo
n=101 Participants
Placebo: placebo capsules, by mouth every evening, daily, for 6 weeks. Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
|
|---|---|---|
|
Clinically Significant Vital Signs - Percentage of Participants With Baseline-to-Endpoint Weight Increase of at Least Seven Percent (7%)
|
22 percentage of participants
|
3 percentage of participants
|
Adverse Events
Olanzapine
Serious events: 3 serious events
Other events: 80 other events
Deaths: 0 deaths
Placebo
Serious events: 5 serious events
Other events: 63 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Olanzapine
Olanzapine: 15mg, capsules, PO at Q HS, daily for 1 week followed by 5-20mg, capsules, PO at Q HS daily for 5 weeks (6 weeks total). Divalproex: dose to maintain blood levels of 75-125 ug/mL, PO, BID, daily for 6 weeks (following d ose achieved in Study Period I)
|
Placebo
Placebo: placebo capsules, PO, at Q HS, daily, for 6 weeks. Divalproex: dose to maintain blood levels of 75-125 ug/mL, PO, BID, daily for 6 weeks (following dose achieved in Study Period I).
|
|---|---|---|
|
General disorders
Asthenia
|
0.00%
0/101
|
0.99%
1/101 • Number of events 1
|
|
General disorders
Chest pain
|
0.00%
0/101
|
0.99%
1/101 • Number of events 1
|
|
General disorders
Death
|
0.99%
1/101 • Number of events 1
|
0.00%
0/101
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.99%
1/101 • Number of events 1
|
0.00%
0/101
|
|
Injury, poisoning and procedural complications
Head injury
|
0.99%
1/101 • Number of events 1
|
0.00%
0/101
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/101
|
0.99%
1/101 • Number of events 1
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.99%
1/101 • Number of events 1
|
0.00%
0/101
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/101
|
0.99%
1/101 • Number of events 1
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/101
|
0.99%
1/101 • Number of events 1
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/101
|
0.99%
1/101 • Number of events 1
|
|
Psychiatric disorders
Bipolar I disorder
|
0.99%
1/101 • Number of events 1
|
0.99%
1/101 • Number of events 1
|
Other adverse events
| Measure |
Olanzapine
Olanzapine: 15mg, capsules, PO at Q HS, daily for 1 week followed by 5-20mg, capsules, PO at Q HS daily for 5 weeks (6 weeks total). Divalproex: dose to maintain blood levels of 75-125 ug/mL, PO, BID, daily for 6 weeks (following d ose achieved in Study Period I)
|
Placebo
Placebo: placebo capsules, PO, at Q HS, daily, for 6 weeks. Divalproex: dose to maintain blood levels of 75-125 ug/mL, PO, BID, daily for 6 weeks (following dose achieved in Study Period I).
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
3.0%
3/101 • Number of events 3
|
0.00%
0/101
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.99%
1/101 • Number of events 1
|
3.0%
3/101 • Number of events 3
|
|
Gastrointestinal disorders
Dry mouth
|
12.9%
13/101 • Number of events 13
|
3.0%
3/101 • Number of events 3
|
|
Gastrointestinal disorders
Dyspepsia
|
0.99%
1/101 • Number of events 1
|
3.0%
3/101 • Number of events 3
|
|
Gastrointestinal disorders
Nausea
|
3.0%
3/101 • Number of events 3
|
0.99%
1/101 • Number of events 1
|
|
Gastrointestinal disorders
Stomach discomfort
|
0.00%
0/101
|
3.0%
3/101 • Number of events 3
|
|
General disorders
Fatigue
|
9.9%
10/101 • Number of events 12
|
4.0%
4/101 • Number of events 5
|
|
General disorders
Oedema peripheral
|
5.9%
6/101 • Number of events 6
|
0.99%
1/101 • Number of events 2
|
|
Infections and infestations
Nasopharyngitis
|
4.0%
4/101 • Number of events 4
|
6.9%
7/101 • Number of events 7
|
|
Investigations
Weight increased
|
20.8%
21/101 • Number of events 21
|
4.0%
4/101 • Number of events 4
|
|
Metabolism and nutrition disorders
Increased appetite
|
12.9%
13/101 • Number of events 13
|
5.0%
5/101 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.0%
3/101 • Number of events 4
|
0.99%
1/101 • Number of events 1
|
|
Nervous system disorders
Akathisia
|
3.0%
3/101 • Number of events 3
|
0.00%
0/101
|
|
Nervous system disorders
Dizziness
|
3.0%
3/101 • Number of events 3
|
3.0%
3/101 • Number of events 4
|
|
Nervous system disorders
Headache
|
5.0%
5/101 • Number of events 6
|
6.9%
7/101 • Number of events 7
|
|
Nervous system disorders
Sedation
|
23.8%
24/101 • Number of events 25
|
4.0%
4/101 • Number of events 5
|
|
Nervous system disorders
Somnolence
|
20.8%
21/101 • Number of events 23
|
5.9%
6/101 • Number of events 6
|
|
Nervous system disorders
Tremor
|
8.9%
9/101 • Number of events 9
|
0.00%
0/101
|
|
Psychiatric disorders
Agitation
|
2.0%
2/101 • Number of events 2
|
4.0%
4/101 • Number of events 4
|
|
Psychiatric disorders
Insomnia
|
2.0%
2/101 • Number of events 2
|
5.9%
6/101 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/101
|
3.0%
3/101 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
3.0%
3/101 • Number of events 3
|
0.00%
0/101
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 1-800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60