Prevention of Relapse & Recurrence of Bipolar Depression

Completed · Phase 4 · Has a placebo group

Conditions studied: Bipolar Disorder

In brief

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.

Key facts

Study ID

NCT00961961

Run by

University of Pennsylvania

People needed

177

Starts

2009-07-01

Expected to finish

2016-09-01

Last updated by the study team

2020-10-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men/women (all races and ethnicity)
• Age at least 18 years old
• Bipolar Type I Disorder
• Current Major Depressive Episode
• Able to understand and provide signed informed consent

You may not qualify if…

• Current alcohol or drug abuse
• Alcohol or drug dependence within 3 months
• Allergic to Fluoxetine or Lithium
• Unstable medical condition (e.g., uncontrolled thyroid, renal, cardiovascular disease)
• Pregnant or nursing women
• Women of child-bearing potential unwilling to use a medically acceptable form of contraception
• Actively suicidal
• Requiring hospitalization
• Use of medication contraindicated with lithium or fluoxetine
• Unable to participate in a year-long trial

Where it is running

• Rush University Medical Center — Chicago, Illinois, United States
• Depression Research Unit — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.