Prevention of Relapse & Recurrence of Bipolar Depression

• Status: Completed
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pennsylvania
• Collaborator: National Institute of Mental Health (NIMH)
• Treatments: Fluoxetine; Lithium Carbonate

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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