CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 139 enrolled
Drug / intervention
olanzapine +3 moredrug
Likely dose
Not stated in 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.

Search/NCT00266630
NCT00266630Phase 3Completed
CompareCT.gov

Efficacy and Safety of Olanzapine in the Extended Treatment for Manic or Mixed Episode of Bipolar I Disorder

Eli Lilly and Company·interventional·Posted Dec 19, 2005·Updated Dec 28, 2010

In Brief

A Phase 3 clinical trial evaluating olanzapine, lithium, and 2 other interventions for Manic or Mixed Episode Associated With Bipolar I Disorder. Completed, enrolled 139 participants across 11 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsManic or Mixed Episode Associated With Bipolar I Disorder
CountriesJapan
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 19, 2005
Enrollment StartNov 1, 2005
Primary CompletionMay 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 20.5 years ago

Interventions

olanzapinedrug

oral, daily

lithiumdrug

Dose adjusted according to local package insert

valproatedrug

Dose adjusted according to local package insert

carbamazepinedrug

Dose adjusted according to local package insert