CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 177 enrolled
Drug / intervention
Lithium / Fluoxetine +1 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/NCT00961961
NCT00961961Phase 4Completed
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Prevention of Relapse & Recurrence of Bipolar Depression

University of Pennsylvania·interventional·Posted Aug 19, 2009·Updated Oct 19, 2020

In Brief

A Phase 4 clinical trial evaluating Lithium / Fluoxetine and Lithium / Placebo for Bipolar Disorder. Completed, enrolled 177 participants across 2 sites.

Detailed Summary

The purpose of this study is to determine whether the long-term use of combined antidepressant plus mood stabilizer therapy is superior to mood stabilizer therapy alone in preventing the relapse and recurrence of bipolar depression.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBipolar Disorder
CountriesUnited States
CollaboratorsNational Institute of Mental Health (NIMH)

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 19, 2009
Enrollment StartJul 1, 2009
Primary CompletionSep 1, 2016
TodayJul 2, 2026
Enrollment to primary: 7.2 yearsPosted 16.9 years ago

Interventions

Lithium / Fluoxetinedrug

Individualized Daily Dosage

Lithium / Placebodrug

Individualized Daily Dosage