CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 202 enrolled
Drug / intervention
olanzapine +2 moredrug
Likely dose
olanzapine 15mgfrom 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/NCT00402324
NCT00402324Phase 4Completed
CompareCT.gov

A Double-Blind Placebo Controlled Trial of Divalproex and Olanzapine in Bipolar I Disorder, Mixed Episode

Eli Lilly and Company·interventional·Posted Nov 22, 2006·Updated Jun 3, 2009

In Brief

A Phase 4 clinical trial evaluating olanzapine, placebo, and 1 other intervention for Bipolar I Disorder. Completed, enrolled 202 participants across 1 site.

Detailed Summary

Whether treatment with olanzapine in combination with mood stabilizer reduces symptoms of both mania and depression more than treatment with mood stabilizer alone, in patients with a mixed episode of bipolar I disorder.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBipolar I Disorder
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 22, 2006
Enrollment StartDec 1, 2006
Primary CompletionFeb 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 19.6 years ago

Interventions

olanzapinedrug

15mg, capsules, by mouth every evening, daily for minimum of one day, followed by 5-20mg, capsules, by mouth every evening, daily for remainder of study (6 weeks total).

placebodrug

placebo, capsules, by mouth every evening, daily, for 6 weeks.

divalproexdrug

dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 52 days (Study Period I and Study Period II).