Phase 3
N=224
Trial of Olanzapine in Patients With Manic or Mixed Episode of Bipolar I Disorder
Bipolar Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00129220 ↗Enrolled (actual)
224
Serious AEs
1.8%
Results posted
Feb 2010
Primary outcome: Primary: Change From Baseline to 3 Week Endpoint in Young Mania Rating Scale (YMRS) Total Score — -12.6; -14.3; -6.8 units on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- olanzapine (Drug); haloperidol (Drug); placebo (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Jan 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to 3 Week Endpoint in Young Mania Rating Scale (YMRS) Total Score |
-12.6; -14.3; -6.8 | <0.001 sig |
| SECONDARY Change From Baseline to 6 Week Endpoint in Young Mania Rating Scale (YMRS) |
-16.0; -14.7; -10.1 | 0.774 |
| SECONDARY Remission Rate of Bipolar Disorder (Olanzapine Versus Haloperidol) |
44.2; 20.0 | 0.064 |
| SECONDARY Change From Baseline to 6 Week Endpoint in Clinical Global Impressions - Bipolar Version (CGI-BP), Overall Severity of Illness |
-1.6; -1.3; -0.9 | 0.171 |
| SECONDARY Change From Baseline to 3 Week and 6 Week Endpoints in Clinical Global Impression - Bipolar Version (CGI-BP) Mania Subscale |
-1.2; -1.7; -0.6; -1.7; -1.9; -1.0 | 0.006 sig |
| SECONDARY Response Rate of Manic Symptoms at 3 Weeks and 6 Weeks |
51.0; 65.0; 44.3; 67.3; 65.0; 55.7 | 0.333 |
| SECONDARY Remission Rate of Manic Symptoms at 3 Weeks and 6 Weeks |
47.1; 65.0; 41.2; 63.5; 60.0; 52.6 | 0.384 |
| SECONDARY Percentage of Participants Who Switched to Symptomatic Depression |
2.4; 16.7; 1.3; 2.4; 16.7; 2.7 | 0.698 |
| SECONDARY Change From Baseline to 3 Week and 6 Week Endpoints in the Positive Subscore of Positive and Negative Syndrome Scale (PANSS) |
-1.8; -1.8; -0.0; -2.2; -1.6; -0.3 | 0.019 sig |
| SECONDARY Percentage of Participants Who Switched to Syndromic Depression |
0.0; 5.3; 0.0; 1.1; 5.3; 0.0 | 0.136 |
| SECONDARY Maximum Change From Baseline During 6-Week Period in Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Total Score |
0.20; 0.50; 0.30; 0.70; 2.70; 0.09 | 0.003 sig |
Summary
The purpose of this study is to confirm the efficacy of olanzapine in the treatment of manic or mixed symptoms associated with bipolar I disorder.
Eligibility Criteria
Inclusion Criteria
- Meet the criteria for manic or mixed episodes according to the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) and have a diagnosis of "294.4x Bipolar I Disorder, Most Recent Episode Manic" or "296.6x Bipolar I Disorder, Most Recent Episode Mixed".
- Have a total score on the Young Mania Rating Scale (YMRS) of at least 20 at Visit 1 and Visit 2.
Exclusion Criteria
- Have received an antidepressant or a psychostimulant within 5 days prior to Visit 1.
- The duration of the current episode is more than 90 days at Visit 1.
- Have a history or a diagnosis of diabetes mellitus.
- Have received any psychotropic medication within 2 days prior to Visit 2 (except for benzodiazepines).
Data sourced from ClinicalTrials.gov (NCT00129220). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.