Phase 4
Completed N=177
Prevention of Relapse & Recurrence of Bipolar Depression
Source: ClinicalTrials.gov NCT00961961 ↗Enrolled (actual)
177
Serious AEs
8.8%
Results posted
Oct 2020
Primary outcomePrimary: Number of Participants With Relapse of Major Depressive Episode Within 1 Year — 4; 5 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
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 |
— | — |
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. Informational only — not medical advice.