CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 892 enrolled
Drug / intervention
Olanzapine and Fluoxetine combination (OFC) +1 moredrug
Likely dose
Olanzapine and Fluoxetine combination (OFC) 3 milligramfrom 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/NCT00958568
NCT00958568Phase 3Completed
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A Study to Assess the Long-Term Efficacy and Safety of Olanzapine and Fluoxetine Combination Versus Fluoxetine Only in the Relapse Prevention of Stabilized Patients With Treatment-Resistant Depression

Eli Lilly and Company·interventional·Posted Aug 13, 2009·Updated Apr 1, 2014

In Brief

A Phase 3 clinical trial evaluating Olanzapine and Fluoxetine combination (OFC) and Fluoxetine for Treatment Resistant Depression. Completed, enrolled 892 participants across 66 sites in 8 countries.

Detailed Summary

The purpose of this study is to determine whether olanzapine and fluoxetine combination (OFC) if used for a long time (47 weeks) makes patients suffering from Treatment Resistant Depression stable, determine if OFC is safe when used to treat patients with Treatment Resistant Depression for a long time (up to 47 weeks), to determine whether olanzapine and fluoxetine combination or fluoxetine alone is better to treat Treatment Resistant Depression when treated for a long time (up to 47 weeks) and to assess the quality of life during treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTreatment Resistant Depression
CountriesArgentina, India, Mexico, Puerto Rico, Russia, South Africa, Turkey (Türkiye), United States
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 13, 2009
Enrollment StartAug 1, 2009
Primary CompletionMar 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 16.9 years ago

Interventions

Olanzapine and Fluoxetine combination (OFC)drug

Open label acute phase: introductory dose for 4 days then 3 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (3/25), 6/25, 12/25, 6/50, 12/50 or 18/50, oral, daily, for 6-8 weeks. Open label stabilization phase: 6/25, 12/25, 6/50, 12/50 or 18/50 mg, oral, daily for 16-20 weeks. Double blind relapse prevention phase: dose determined during stabilization phase at Week 17, oral, daily, for 27 weeks.

Fluoxetinedrug

25 or 50 mg/day fixed dosing for 27 weeks