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Prevention of Relapse & Recurrence of Bipolar Depression

NCT00961961 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 177

Last updated 2020-10-19

Study results available
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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.

Conditions

Interventions

DRUG

Lithium / Fluoxetine

Individualized Daily Dosage

DRUG

Lithium / Placebo

Individualized Daily Dosage

Sponsors & Collaborators

Principal Investigators

  • Robert J. DeRubeis, PhD · University of Pennsylvania

  • John M Zajecka, MD · Rush University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-01
Primary Completion
2016-09-01
Completion
2016-09-01

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00961961 on ClinicalTrials.gov