At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 514 enrolled
Drug / intervention
Olanzapine +1 moredrug
Likely dose
Olanzapine 20 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Efficacy and Safety of Olanzapine in the Treatment of Patients With Bipolar I Disorder, Depressed: A Randomized, Double-Blind Comparison With Placebo
In Brief
A Phase 3 clinical trial evaluating Olanzapine and Placebo for Depression, Bipolar. Completed, enrolled 514 participants across 16 sites in 3 countries.
Detailed Summary
The purpose of this study is to assess whether olanzapine is superior to placebo in patients with bipolar depression.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDepression, Bipolar
CountriesChina, Japan, South Korea
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 2007
Enrollment StartAug 2007
Primary CompletionMar 2010
Study CompletionJul 2010
TodayJul 2026
First PostedAug 1, 2007
Enrollment StartAug 1, 2007
Primary CompletionMar 1, 2010
Study CompletionJul 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 18.9 years ago
Interventions
Olanzapinedrug
5-20 mg, oral, once daily, for 24 weeks (participants randomized to olanzapine in double-blind treatment period) or 18 weeks (participants randomized to placebo in double-blind treatment period).
Placebodrug
placebo tablets, oral, once daily at bedtime, 6 weeks