Phase 3
Completed N=139
Efficacy and Safety of Olanzapine in the Extended Treatment for Manic or Mixed Episode of Bipolar I Disorder
Manic or Mixed Episode Associated With Bipolar I Disorder
Source: ClinicalTrials.gov NCT00266630 ↗
Enrolled (actual)
139
Serious AEs
0.7%
Results posted
Jun 2010
Primary outcomePrimary: Change From Baseline to Endpoint in Young Mania Rating Scale (YMRS) Total Scores - Olanzapine Monotherapy Arm Only — -3.0 units on a scale
Summary
The efficacy and safety of the extended treatment to patients with most recent episode manic or mixed who completed previous double blind study (F1D-JE-BMAC [Study BMAC]) will be examined.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Endpoint in Young Mania Rating Scale (YMRS) Total Scores - Olanzapine Monotherapy Arm Only |
-3.0 | — |
| PRIMARY Number of Participants With Response of Manic Symptoms - Olanzapine Monotherapy Arm Only |
97 | — |
| PRIMARY Number of Participants With Remission of Mania - Olanzapine Monotherapy Arm Only |
93 | — |
| PRIMARY Number of Participants With Relapse of Manic Symptoms - Olanzapine Monotherapy Arm Only |
3 | — |
| SECONDARY Change From Baseline to Endpoint on the YMRS Total Score - Olanzapine + Mood Stabilizer Only |
-19.8 | — |
| SECONDARY Clinical Global Impressions - Bipolar Version, Severity of Illness (CGI-BP) Overall, Visit Data |
1.9; 4.7; 1.8; 4.1; 1.8; 3.7 | — |
| SECONDARY Number of Participants Who Experienced Switch to Symptomatic Depression as Measured by the Hamilton Depression Scale - 17 Item Version (HAMD-17) |
4; 1 | — |
| SECONDARY Number of Participants With Relapse of Depressive Symptoms |
4 | — |
| SECONDARY Number of Participants Who Experienced Remission of Bipolar Disorder |
54; 12 | — |
| SECONDARY Positive and Negative Syndrome Scale Positive Scores - Visit Data |
7.7; 12.5; 7.5; 10.5; 7.5; 10.1 | — |
| SECONDARY Number of Participants Who Switched to Syndromic Depression |
8; 4 | — |
| SECONDARY Maximum Change From Baseline to Endpoint on the Drug Induced Extra-Pyramidal Symptoms Scale (DIEPSS) - Total Score |
0.35; 0.18; 0.05; 0.64 | — |
| SECONDARY Number of Participants With Treatment-Emergent Parkinsonism Based on DIEPSS Scores |
1; 3 | — |
| SECONDARY Number of Participants With Treatment-Emergent Akathisia Based on DIEPSS Scores |
3; 2 | — |
| SECONDARY Number of Participants With Treatment-Emergent Dystonia Based on DIEPSS Scores |
0; 1 | — |
| SECONDARY Number of Participants With Treatment-Emergent Dyskenisia Based on DIEPSS Scores |
0; 0 | — |
| SECONDARY Number of Participants With Potentially Clinically Significant Changes in Laboratory Analytes |
5; 2; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Potentially Clinically Significant Changes in Vital Signs and Weight |
6; 2; 0; 0; 4; 1 | — |
| SECONDARY Number of Participants With Potentially Clinically Significant Changes in Electrocardiograms - High Fridericia Corrected QT Interval (QTcF) |
0; 0 | — |
| SECONDARY Number of Participants With Treatment-emergent Abnormal, High, or Low Laboratory Values |
10; 3; 5; 1; 1; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Enrolled in and completed Study BMAC (NCT00129220), or those who discontinued Study BMAC at Visit 4 or Visit 5 due to lack of efficacy and for whom the Young Mania Rating Scale (YMRS) total score at the time of discontinuation was not lower than that at baseline of Study BMAC
- Are diagnosed as "294.4x Bipolar I Disorder, Most Recent Episode Manic" or "296.6x Bipolar I Disorder, Most Recent Episode Mixed," as determined by the Mini-International Neuropsychiatric Interview (MINI)
Exclusion Criteria
- Have a diagnosis of diabetes mellitus
- Significant protocol deviation in Study BMAC
- The actual date of the final visit of Study BMAC is 4 days or more later than the scheduled date of first visit in Study BMEX
Data sourced from ClinicalTrials.gov (NCT00266630). 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. Informational only — not medical advice.