Phase 4
N=177
Prevention of Relapse & Recurrence of Bipolar Depression
Bipolar Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00961961 ↗Enrolled (actual)
177
Serious AEs
8.8%
Results posted
Oct 2020
Primary outcome: Primary: Number of Participants With Relapse of Major Depressive Episode Within 1 Year — 4; 5 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Lithium / Fluoxetine (Drug); Lithium / Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Pennsylvania
- Primary completion
- Sep 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Relapse of Major Depressive Episode Within 1 Year |
4; 5 | — |
| SECONDARY Number of Participants With an Onset of a Manic Episode Within 1 Year |
0; 0; 0; 0 | — |
| SECONDARY Number of Participants With an Onset of a Hypomanic Episode Within 1 Year |
0; 0; 0; 0 | — |
| SECONDARY Number of Participants With the Onset of a Sub-Syndromal Mood Conversion Episode Within 1 Year |
— | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00961961). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.