Trial Outcomes & Findings for Trial of Olanzapine in Patients With Manic or Mixed Episode of Bipolar I Disorder (NCT NCT00129220)
NCT ID: NCT00129220
Last Updated: 2010-12-28
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.
COMPLETED
PHASE3
224 participants
Baseline, 3 weeks
2010-12-28
Participant Flow
Study Period I was a week-long Screening Period. Study Period II was a 3-week-long Early Double-Blind Period. Study Period III was a 3-week-long Last Double-Blind Period.
Participant milestones
| Measure |
Olanzapine
olanzapine: 5 to 20 mg per day for 6 weeks
|
Haloperidol
haloperidol: 2.5 to 10 mg per day for 6 weeks
|
Placebo
placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks
|
|---|---|---|---|
|
Study Period II
STARTED
|
105
|
20
|
99
|
|
Study Period II
Received at Least One Dose of Study Drug
|
104
|
20
|
97
|
|
Study Period II
COMPLETED
|
72
|
8
|
52
|
|
Study Period II
NOT COMPLETED
|
33
|
12
|
47
|
|
Study Period III
STARTED
|
72
|
8
|
52
|
|
Study Period III
COMPLETED
|
59
|
7
|
42
|
|
Study Period III
NOT COMPLETED
|
13
|
1
|
10
|
Reasons for withdrawal
| Measure |
Olanzapine
olanzapine: 5 to 20 mg per day for 6 weeks
|
Haloperidol
haloperidol: 2.5 to 10 mg per day for 6 weeks
|
Placebo
placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks
|
|---|---|---|---|
|
Study Period II
Adverse Event
|
9
|
5
|
7
|
|
Study Period II
Lack of Efficacy
|
15
|
1
|
28
|
|
Study Period II
Entry Criteria Not Met
|
2
|
0
|
2
|
|
Study Period II
Protocol Violation
|
4
|
2
|
1
|
|
Study Period II
Physician Decision
|
0
|
1
|
0
|
|
Study Period II
Withdrawal by Subject
|
1
|
3
|
4
|
|
Study Period II
Reason Not Specified
|
2
|
0
|
5
|
|
Study Period III
Adverse Event
|
1
|
0
|
3
|
|
Study Period III
Protocol Violation
|
1
|
1
|
2
|
|
Study Period III
Withdrawal by Subject
|
1
|
0
|
3
|
|
Study Period III
Sponsor Decision
|
1
|
0
|
0
|
|
Study Period III
Reason Not Specified
|
9
|
0
|
2
|
Baseline Characteristics
Trial of Olanzapine in Patients With Manic or Mixed Episode of Bipolar I Disorder
Baseline characteristics by cohort
| Measure |
Olanzapine
n=104 Participants
olanzapine: 5 to 20 mg per day for 6 weeks
|
Haloperidol
n=20 Participants
haloperidol: 2.5 to 10 mg per day for 6 weeks
|
Placebo
n=97 Participants
placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks
|
Total
n=221 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
43.1 years
STANDARD_DEVIATION 12.0 • n=5 Participants
|
49.3 years
STANDARD_DEVIATION 11.9 • n=7 Participants
|
42.5 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
43.4 years
STANDARD_DEVIATION 11.6 • n=4 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
121 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
49 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
100 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Japanese
|
104 participants
n=5 Participants
|
20 participants
n=7 Participants
|
97 participants
n=5 Participants
|
221 participants
n=4 Participants
|
|
Region of Enrollment
Japan
|
104 participants
n=5 Participants
|
20 participants
n=7 Participants
|
97 participants
n=5 Participants
|
221 participants
n=4 Participants
|
|
Current Illness Episode: Manic versus Mixed
Manic
|
95 participants
n=5 Participants
|
19 participants
n=7 Participants
|
89 participants
n=5 Participants
|
203 participants
n=4 Participants
|
|
Current Illness Episode: Manic versus Mixed
Mixed
|
9 participants
n=5 Participants
|
1 participants
n=7 Participants
|
8 participants
n=5 Participants
|
18 participants
n=4 Participants
|
|
Current Illness Episode: Psychotic versus Nonpsychotic
Psychotic
|
17 participants
n=5 Participants
|
4 participants
n=7 Participants
|
19 participants
n=5 Participants
|
40 participants
n=4 Participants
|
|
Current Illness Episode: Psychotic versus Nonpsychotic
Nonpsychotic
|
87 participants
n=5 Participants
|
16 participants
n=7 Participants
|
78 participants
n=5 Participants
|
181 participants
n=4 Participants
|
|
Hospitalization Status
In-Patients
|
41 participants
n=5 Participants
|
10 participants
n=7 Participants
|
38 participants
n=5 Participants
|
89 participants
n=4 Participants
|
|
Hospitalization Status
Out-Patients
|
63 participants
n=5 Participants
|
10 participants
n=7 Participants
|
59 participants
n=5 Participants
|
132 participants
n=4 Participants
|
|
Psychosis
Mood-Congruent
|
16 participants
n=5 Participants
|
4 participants
n=7 Participants
|
19 participants
n=5 Participants
|
39 participants
n=4 Participants
|
|
Psychosis
Mood-Incongruent
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
17-Item Hamilton Depression Rating Scale Total Score
|
4.5 units on a scale
STANDARD_DEVIATION 3.9 • n=5 Participants
|
4.1 units on a scale
STANDARD_DEVIATION 3.7 • n=7 Participants
|
4.9 units on a scale
STANDARD_DEVIATION 4.5 • n=5 Participants
|
4.7 units on a scale
STANDARD_DEVIATION 4.1 • n=4 Participants
|
|
Age of Onset of Illness
|
31.2 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
37.7 years
STANDARD_DEVIATION 12.5 • n=7 Participants
|
30.9 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
31.6 years
STANDARD_DEVIATION 11.4 • n=4 Participants
|
|
Clinical Global Impression-Severity of Illness, Bipolar Version (CGI-BP)
Mania
|
4.2 units on a scale
STANDARD_DEVIATION 1.0 • n=5 Participants
|
4.6 units on a scale
STANDARD_DEVIATION 0.8 • n=7 Participants
|
4.1 units on a scale
STANDARD_DEVIATION 1.1 • n=5 Participants
|
4.2 units on a scale
STANDARD_DEVIATION 1.0 • n=4 Participants
|
|
Clinical Global Impression-Severity of Illness, Bipolar Version (CGI-BP)
Depression
|
1.3 units on a scale
STANDARD_DEVIATION 0.6 • n=5 Participants
|
1.1 units on a scale
STANDARD_DEVIATION 0.2 • n=7 Participants
|
1.3 units on a scale
STANDARD_DEVIATION 0.7 • n=5 Participants
|
1.2 units on a scale
STANDARD_DEVIATION 0.6 • n=4 Participants
|
|
Clinical Global Impression-Severity of Illness, Bipolar Version (CGI-BP)
Overall Mood
|
4.1 units on a scale
STANDARD_DEVIATION 1.0 • n=5 Participants
|
4.4 units on a scale
STANDARD_DEVIATION 1.2 • n=7 Participants
|
4.1 units on a scale
STANDARD_DEVIATION 1.1 • n=5 Participants
|
4.1 units on a scale
STANDARD_DEVIATION 1.1 • n=4 Participants
|
|
Height
|
162.74 centimeters (cm)
STANDARD_DEVIATION 8.07 • n=5 Participants
|
162.10 centimeters (cm)
STANDARD_DEVIATION 7.87 • n=7 Participants
|
163.09 centimeters (cm)
STANDARD_DEVIATION 9.66 • n=5 Participants
|
162.84 centimeters (cm)
STANDARD_DEVIATION 8.76 • n=4 Participants
|
|
Length of Current Illness Episode
|
34.6 days
STANDARD_DEVIATION 22.9 • n=5 Participants
|
34.2 days
STANDARD_DEVIATION 22.0 • n=7 Participants
|
33.5 days
STANDARD_DEVIATION 25.4 • n=5 Participants
|
34.1 days
STANDARD_DEVIATION 23.9 • n=4 Participants
|
|
Positive and Negative Syndrome Scale Positive Subscale Score
|
11.5 units on a scale
STANDARD_DEVIATION 4.8 • n=5 Participants
|
11.3 units on a scale
STANDARD_DEVIATION 4.5 • n=7 Participants
|
10.7 units on a scale
STANDARD_DEVIATION 4.7 • n=5 Participants
|
11.1 units on a scale
STANDARD_DEVIATION 4.7 • n=4 Participants
|
|
Weight
|
60.88 kilograms (kg)
STANDARD_DEVIATION 11.69 • n=5 Participants
|
59.20 kilograms (kg)
STANDARD_DEVIATION 9.87 • n=7 Participants
|
61.86 kilograms (kg)
STANDARD_DEVIATION 13.78 • n=5 Participants
|
61.17 kilograms (kg)
STANDARD_DEVIATION 12.49 • n=4 Participants
|
|
Young Mania Rating Scale (YMRS) Total Score
|
27.7 units on a scale
STANDARD_DEVIATION 5.9 • n=5 Participants
|
26.6 units on a scale
STANDARD_DEVIATION 4.5 • n=7 Participants
|
26.9 units on a scale
STANDARD_DEVIATION 5.6 • n=5 Participants
|
27.3 units on a scale
STANDARD_DEVIATION 5.7 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, 3 weeksPopulation: Participants in the Full Analysis Set: participants who had baseline and post-baseline measurement.
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=104 Participants
olanzapine: 5 to 20 mg per day for 6 weeks
|
Haloperidol
n=20 Participants
haloperidol: 2.5 to 10 mg per day for 6 weeks
|
Placebo
n=97 Participants
placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks
|
|---|---|---|---|
|
Change From Baseline to 3 Week Endpoint in Young Mania Rating Scale (YMRS) Total Score
|
-12.6 units on a scale
Standard Deviation 10.0
|
-14.3 units on a scale
Standard Deviation 11.4
|
-6.8 units on a scale
Standard Deviation 14.0
|
SECONDARY outcome
Timeframe: Baseline, 6 weeksPopulation: Participants in the Full Analysis Set: participants who had baseline and post-baseline measurement.
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=104 Participants
olanzapine: 5 to 20 mg per day for 6 weeks
|
Haloperidol
n=20 Participants
haloperidol: 2.5 to 10 mg per day for 6 weeks
|
Placebo
n=97 Participants
placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks
|
|---|---|---|---|
|
Change From Baseline to 6 Week Endpoint in Young Mania Rating Scale (YMRS)
|
-16.0 units on a scale
Standard Deviation 11.4
|
-14.7 units on a scale
Standard Deviation 13.1
|
-10.1 units on a scale
Standard Deviation 15.8
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: Participants in the Full Analysis Set: participants who had baseline and post-baseline measurement.
Remission of bipolar disorder was defined as completing the 6-week period with meeting the criteria for Young Mania Rating Scale (YMRS) total score of 12 or less and 17-Item Hamilton Depression Rating Scale (HAMD-17) total scores of 7 or less at Week 6. YMRS is an 11-item scale measuring severity of manic episodes; total score ranges = 0 (normal) to 60 (severe). The 17-item HAMD measures depression severity; total score ranges = 0 (normal) to 52 (severe). Remission Rate (percent) = number of patients meeting remission criteria divided by number of patients in treatment arm, multiplied by 100.
Outcome measures
| Measure |
Olanzapine
n=104 Participants
olanzapine: 5 to 20 mg per day for 6 weeks
|
Haloperidol
n=20 Participants
haloperidol: 2.5 to 10 mg per day for 6 weeks
|
Placebo
placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks
|
|---|---|---|---|
|
Remission Rate of Bipolar Disorder (Olanzapine Versus Haloperidol)
|
44.2 percentage of participants
|
20.0 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline, 6 weeksPopulation: Participants in the Full Analysis Set: participants who had baseline and post-baseline measurement.
A global rating scale for severity of patients adapted to bipolar disorder. Measures severity of the patient's overall severity of overall mood symptoms on a scale of 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
Outcome measures
| Measure |
Olanzapine
n=104 Participants
olanzapine: 5 to 20 mg per day for 6 weeks
|
Haloperidol
n=20 Participants
haloperidol: 2.5 to 10 mg per day for 6 weeks
|
Placebo
n=97 Participants
placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks
|
|---|---|---|---|
|
Change From Baseline to 6 Week Endpoint in Clinical Global Impressions - Bipolar Version (CGI-BP), Overall Severity of Illness
|
-1.6 units on a scale
Standard Deviation 1.5
|
-1.3 units on a scale
Standard Deviation 1.8
|
-0.9 units on a scale
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: Baseline, 3 weeks, 6 weeksPopulation: Participants in the Full Analysis Set: participants who had baseline and post-baseline measurement.
A global rating scale for severity of patients adapted to bipolar disorder. Measures severity of the patient's overall severity of manic symptoms on a scale of 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
Outcome measures
| Measure |
Olanzapine
n=104 Participants
olanzapine: 5 to 20 mg per day for 6 weeks
|
Haloperidol
n=20 Participants
haloperidol: 2.5 to 10 mg per day for 6 weeks
|
Placebo
n=97 Participants
placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks
|
|---|---|---|---|
|
Change From Baseline to 3 Week and 6 Week Endpoints in Clinical Global Impression - Bipolar Version (CGI-BP) Mania Subscale
6-Week Change
|
-1.7 units on a scale
Standard Deviation 1.5
|
-1.9 units on a scale
Standard Deviation 1.9
|
-1.0 units on a scale
Standard Deviation 1.7
|
|
Change From Baseline to 3 Week and 6 Week Endpoints in Clinical Global Impression - Bipolar Version (CGI-BP) Mania Subscale
3-Week Change
|
-1.2 units on a scale
Standard Deviation 1.2
|
-1.7 units on a scale
Standard Deviation 1.7
|
-0.6 units on a scale
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: Baseline, 3 weeks, 6 weeksPopulation: Participants in the Full Analysis Set: participants who had baseline and post-baseline measurement.
Participants who had 50 percent or more decrease from the baseline in YMRS total scores were defined as a responder. 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. Response Rate (percent) = number of patients meeting response criterion for manic symptom divided by number of patients in treatment arm, multiplied by 100.
Outcome measures
| Measure |
Olanzapine
n=104 Participants
olanzapine: 5 to 20 mg per day for 6 weeks
|
Haloperidol
n=20 Participants
haloperidol: 2.5 to 10 mg per day for 6 weeks
|
Placebo
n=97 Participants
placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks
|
|---|---|---|---|
|
Response Rate of Manic Symptoms at 3 Weeks and 6 Weeks
3 Week Response Rate
|
51.0 percentage of participants
|
65.0 percentage of participants
|
44.3 percentage of participants
|
|
Response Rate of Manic Symptoms at 3 Weeks and 6 Weeks
6 Week Response Rate
|
67.3 percentage of participants
|
65.0 percentage of participants
|
55.7 percentage of participants
|
SECONDARY outcome
Timeframe: 3 weeks, 6 weeksPopulation: Participants in the Full Analysis Set: participants who had baseline and post-baseline measurement.
Participants who had a YMRS total score of 12 or less were considered to be in remission of manic symptoms. YMRS is an 11-item scale that measures severity of manic episodes; total score ranges from 0 (normal) to 60 (severe). Remission Rate (percent) = number of patients meeting remission criteria divided by number of patients in treatment arm, multiplied by 100.
Outcome measures
| Measure |
Olanzapine
n=104 Participants
olanzapine: 5 to 20 mg per day for 6 weeks
|
Haloperidol
n=20 Participants
haloperidol: 2.5 to 10 mg per day for 6 weeks
|
Placebo
n=97 Participants
placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks
|
|---|---|---|---|
|
Remission Rate of Manic Symptoms at 3 Weeks and 6 Weeks
3-Week Remission Rate
|
47.1 percentage of participants
|
65.0 percentage of participants
|
41.2 percentage of participants
|
|
Remission Rate of Manic Symptoms at 3 Weeks and 6 Weeks
6-Week Remission Rate
|
63.5 percentage of participants
|
60.0 percentage of participants
|
52.6 percentage of participants
|
SECONDARY outcome
Timeframe: 3 weeks, 6 weeksPopulation: Participants in the Full Analysis Set (participants who had baseline and post-baseline measurement) who had HAMD-17 total scores ≤7 at baseline.
Switch to symptomatic depression was defined as HAMD-17 total score ≥13 at any time in the participants with HAMD-17 total scores ≤7 at baseline. The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).
Outcome measures
| Measure |
Olanzapine
n=83 Participants
olanzapine: 5 to 20 mg per day for 6 weeks
|
Haloperidol
n=18 Participants
haloperidol: 2.5 to 10 mg per day for 6 weeks
|
Placebo
n=75 Participants
placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks
|
|---|---|---|---|
|
Percentage of Participants Who Switched to Symptomatic Depression
3-Week Symptomatic Depression Rate
|
2.4 percentage of participants
|
16.7 percentage of participants
|
1.3 percentage of participants
|
|
Percentage of Participants Who Switched to Symptomatic Depression
6-Week Symptomatic Depression Rate
|
2.4 percentage of participants
|
16.7 percentage of participants
|
2.7 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, 3 weeks, 6 weeksPopulation: Participants in the Full Analysis Set: participants who had baseline and post-baseline measurement.
Assesses positive symptoms associated with schizophrenia. 7 items make up the Positive scale (ex. delusions, conceptual disorganization, and hallucinatory behavior). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total Positive Subscale scores range from 7 to 49. For this study, the score was converted to 0 to 6 for each item range; hence, the total positive subscale score ranges from 0 to 42.
Outcome measures
| Measure |
Olanzapine
n=104 Participants
olanzapine: 5 to 20 mg per day for 6 weeks
|
Haloperidol
n=20 Participants
haloperidol: 2.5 to 10 mg per day for 6 weeks
|
Placebo
n=97 Participants
placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks
|
|---|---|---|---|
|
Change From Baseline to 3 Week and 6 Week Endpoints in the Positive Subscore of Positive and Negative Syndrome Scale (PANSS)
3-Week Change
|
-1.8 units on a scale
Standard Deviation 4.1
|
-1.8 units on a scale
Standard Deviation 4.3
|
-0.0 units on a scale
Standard Deviation 5.3
|
|
Change From Baseline to 3 Week and 6 Week Endpoints in the Positive Subscore of Positive and Negative Syndrome Scale (PANSS)
6-Week Change
|
-2.2 units on a scale
Standard Deviation 4.4
|
-1.6 units on a scale
Standard Deviation 4.3
|
-0.3 units on a scale
Standard Deviation 5.7
|
SECONDARY outcome
Timeframe: 3 weeks, 6 weeksPopulation: Participants in the Full Analysis Set (participants who had baseline and post-baseline measurement) who had manic (not mixed) episode at baseline.
Switch to syndromic depression was operationally defined by meeting both of the following criteria: At baseline, the symptoms did not meet the criteria for a mixed episode based on the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR). The critiera were met for a Major Depressive Episode (MDE), at any point after randomization, based on DSM-IV-TR. Rather than the 2-week period required for an MDE in the DSM-IV-TR, the patient had to meet the criteria of an MDE for at least 7 consecutive days (during Weeks 1 through 6).
Outcome measures
| Measure |
Olanzapine
n=95 Participants
olanzapine: 5 to 20 mg per day for 6 weeks
|
Haloperidol
n=19 Participants
haloperidol: 2.5 to 10 mg per day for 6 weeks
|
Placebo
n=89 Participants
placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks
|
|---|---|---|---|
|
Percentage of Participants Who Switched to Syndromic Depression
3-Week Syndromic Depression Rate
|
0.0 percentage of participants
|
5.3 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants Who Switched to Syndromic Depression
6-Week Syndromic Depression Rate
|
1.1 percentage of participants
|
5.3 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to 6 weeksPopulation: Participants in the Safety Analysis Set (participants who had baseline and post-baseline measurements). Participants were included in the treatment group for which they actually received treatment.
Drug Induced Extra-Pyramidal Symptoms Scale (DIEPSS) is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the sum of the 8 item scores, for a total range of 0 (normal) to 32 (severe).
Outcome measures
| Measure |
Olanzapine
n=105 Participants
olanzapine: 5 to 20 mg per day for 6 weeks
|
Haloperidol
n=20 Participants
haloperidol: 2.5 to 10 mg per day for 6 weeks
|
Placebo
n=96 Participants
placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks
|
|---|---|---|---|
|
Maximum Change From Baseline During 6-Week Period in Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Total Score
Baseline
|
0.20 units on a scale
Standard Deviation 0.66
|
0.50 units on a scale
Standard Deviation 1.19
|
0.30 units on a scale
Standard Deviation 0.91
|
|
Maximum Change From Baseline During 6-Week Period in Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Total Score
Maximum Change from Baseline
|
0.70 units on a scale
Standard Deviation 1.51
|
2.70 units on a scale
Standard Deviation 2.89
|
0.09 units on a scale
Standard Deviation 1.09
|
Adverse Events
Olanzapine
Haloperidol
Placebo
Serious adverse events
| Measure |
Olanzapine
n=105 participants at risk
olanzapine: 5 to 20 mg per day for 6 weeks
|
Haloperidol
n=20 participants at risk
haloperidol: 2.5 to 10 mg per day for 6 weeks
|
Placebo
n=96 participants at risk
placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks
|
|---|---|---|---|
|
Nervous system disorders
Status epilepticus
|
0.00%
0/105
|
0.00%
0/20
|
1.0%
1/96 • Number of events 1
|
|
Psychiatric disorders
Bipolar I disorder
|
0.95%
1/105 • Number of events 1
|
0.00%
0/20
|
1.0%
1/96 • Number of events 1
|
|
Psychiatric disorders
Mania
|
0.00%
0/105
|
0.00%
0/20
|
1.0%
1/96 • Number of events 1
|
Other adverse events
| Measure |
Olanzapine
n=105 participants at risk
olanzapine: 5 to 20 mg per day for 6 weeks
|
Haloperidol
n=20 participants at risk
haloperidol: 2.5 to 10 mg per day for 6 weeks
|
Placebo
n=96 participants at risk
placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks
|
|---|---|---|---|
|
Eye disorders
Asthenopia
|
0.00%
0/105
|
0.00%
0/20
|
2.1%
2/96 • Number of events 2
|
|
Gastrointestinal disorders
Cheilitis
|
0.95%
1/105 • Number of events 1
|
5.0%
1/20 • Number of events 1
|
0.00%
0/96
|
|
Gastrointestinal disorders
Constipation
|
9.5%
10/105 • Number of events 10
|
10.0%
2/20 • Number of events 2
|
3.1%
3/96 • Number of events 3
|
|
Gastrointestinal disorders
Diarrhoea
|
0.95%
1/105 • Number of events 1
|
0.00%
0/20
|
4.2%
4/96 • Number of events 4
|
|
Gastrointestinal disorders
Nausea
|
1.9%
2/105 • Number of events 2
|
0.00%
0/20
|
2.1%
2/96 • Number of events 2
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
0.00%
0/105
|
5.0%
1/20 • Number of events 1
|
0.00%
0/96
|
|
Gastrointestinal disorders
Vomiting
|
1.9%
2/105 • Number of events 2
|
5.0%
1/20 • Number of events 1
|
1.0%
1/96 • Number of events 1
|
|
General disorders
Hunger
|
2.9%
3/105 • Number of events 3
|
0.00%
0/20
|
0.00%
0/96
|
|
General disorders
Malaise
|
5.7%
6/105 • Number of events 6
|
10.0%
2/20 • Number of events 2
|
4.2%
4/96 • Number of events 4
|
|
General disorders
Oedema
|
0.00%
0/105
|
0.00%
0/20
|
2.1%
2/96 • Number of events 2
|
|
General disorders
Thirst
|
15.2%
16/105 • Number of events 16
|
5.0%
1/20 • Number of events 1
|
2.1%
2/96 • Number of events 2
|
|
Infections and infestations
Nasopharyngitis
|
8.6%
9/105 • Number of events 9
|
10.0%
2/20 • Number of events 2
|
9.4%
9/96 • Number of events 9
|
|
Injury, poisoning and procedural complications
Contusion
|
3.8%
4/105 • Number of events 5
|
0.00%
0/20
|
1.0%
1/96 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fall
|
1.9%
2/105 • Number of events 2
|
5.0%
1/20 • Number of events 1
|
1.0%
1/96 • Number of events 1
|
|
Injury, poisoning and procedural complications
Subcutaneous haematoma
|
0.00%
0/105
|
5.0%
1/20 • Number of events 1
|
0.00%
0/96
|
|
Investigations
Blood pressure decreased
|
0.00%
0/105
|
5.0%
1/20 • Number of events 1
|
0.00%
0/96
|
|
Investigations
Blood triglycerides increased
|
4.8%
5/105 • Number of events 5
|
0.00%
0/20
|
2.1%
2/96 • Number of events 2
|
|
Investigations
Electrocardiogram qt prolonged
|
0.95%
1/105 • Number of events 1
|
0.00%
0/20
|
2.1%
2/96 • Number of events 2
|
|
Investigations
Glycosylated haemoglobin increased
|
0.00%
0/105
|
0.00%
0/20
|
2.1%
2/96 • Number of events 2
|
|
Investigations
Weight decreased
|
0.00%
0/105
|
0.00%
0/20
|
2.1%
2/96 • Number of events 2
|
|
Investigations
Weight increased
|
9.5%
10/105 • Number of events 10
|
5.0%
1/20 • Number of events 1
|
4.2%
4/96 • Number of events 4
|
|
Metabolism and nutrition disorders
Increased appetite
|
6.7%
7/105 • Number of events 7
|
5.0%
1/20 • Number of events 1
|
4.2%
4/96 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.95%
1/105 • Number of events 1
|
5.0%
1/20 • Number of events 1
|
0.00%
0/96
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/105
|
0.00%
0/20
|
2.1%
2/96 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/105
|
5.0%
1/20 • Number of events 1
|
0.00%
0/96
|
|
Nervous system disorders
Akathisia
|
2.9%
3/105 • Number of events 3
|
15.0%
3/20 • Number of events 5
|
0.00%
0/96
|
|
Nervous system disorders
Dizziness
|
6.7%
7/105 • Number of events 8
|
0.00%
0/20
|
1.0%
1/96 • Number of events 2
|
|
Nervous system disorders
Dystonia
|
0.00%
0/105
|
15.0%
3/20 • Number of events 3
|
1.0%
1/96 • Number of events 1
|
|
Nervous system disorders
Headache
|
4.8%
5/105 • Number of events 5
|
5.0%
1/20 • Number of events 1
|
3.1%
3/96 • Number of events 3
|
|
Nervous system disorders
Sedation
|
1.9%
2/105 • Number of events 2
|
5.0%
1/20 • Number of events 1
|
0.00%
0/96
|
|
Nervous system disorders
Somnolence
|
23.8%
25/105 • Number of events 26
|
15.0%
3/20 • Number of events 3
|
15.6%
15/96 • Number of events 17
|
|
Nervous system disorders
Tremor
|
2.9%
3/105 • Number of events 3
|
10.0%
2/20 • Number of events 2
|
1.0%
1/96 • Number of events 1
|
|
Psychiatric disorders
Depressive symptom
|
0.00%
0/105
|
5.0%
1/20 • Number of events 1
|
0.00%
0/96
|
|
Psychiatric disorders
Insomnia
|
0.95%
1/105 • Number of events 1
|
5.0%
1/20 • Number of events 1
|
1.0%
1/96 • Number of events 1
|
|
Psychiatric disorders
Mania
|
0.95%
1/105 • Number of events 1
|
5.0%
1/20 • Number of events 1
|
0.00%
0/96
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.95%
1/105 • Number of events 1
|
0.00%
0/20
|
2.1%
2/96 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/105
|
5.0%
1/20 • Number of events 1
|
1.0%
1/96 • Number of events 1
|
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