At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 224 enrolled
Drug / intervention
olanzapine +2 moredrug
Likely dose
Olanzapine 5-20 mg orally once daily (evening), for 6 weeksAI-extracted
Key inclusion· 2
- ✓DSM-IV-TR diagnosis of Bipolar I Disorder with current manic or mixed episode
- ✓Young Mania Rating Scale (YMRS) total score ≥20 at both Visit 1 and Visit 2
Key exclusion· 4
- ✕Antidepressant or psychostimulant use within 5 days prior to Visit 1
- ✕Current manic or mixed episode duration exceeds 90 days
- ✕History or current diagnosis of diabetes mellitus
- ✕Any psychotropic medication (except benzodiazepines) within 2 days prior to Visit 2
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Placebo- and Haloperidol-Controlled Double-Blind Trial of Olanzapine in Patients With Manic or Mixed Episode of Bipolar I Disorder
In Brief
A Phase 3 clinical trial evaluating olanzapine, haloperidol, and 1 other intervention for Bipolar Disorder. Completed, enrolled 224 participants across 16 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBipolar Disorder
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJul 2005
First PostedAug 2005
Primary CompletionJan 2009
TodayJul 2026
First PostedAug 11, 2005
Enrollment StartJul 1, 2005
Primary CompletionJan 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 20.9 years ago
Interventions
olanzapinedrug
5-20 mg, oral, once daily (evening), for 6 weeks
haloperidoldrug
2.5-10 mg, oral, twice daily (morning and evening), for 6 weeks.
placebodrug
placebo, oral tablets, twice daily (morning and evening), for 3 weeks