drugset / Trial / NCT00044616
Relapse Prevention for Bipolar Type-II Disorder
Phase 4
Completed
180 enrolled
University of Pennsylvania
National Institute of Mental Health (NIMH) · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
This 62-week study will compare the safety and effectiveness of fluoxetine (Prozac®), lithium, the combination of these two medications, and placebo in treating and preventing recurrent depressive episodes in people with bipolar type II disorder.
Timeline
- Start
- 2001-02
- Primary completion
- 2007-01
- Completion
- 2007-01
Publications
- Amsterdam JD, Luo L, Shults J. Efficacy and mood conversion rate during long-term fluoxetine v. lithium monotherapy in rapid- and non-rapid-cycling bipolar II disorder. Br J Psychiatry. 2013 Apr;202(4):301-6. doi: 10.1192/bjp.bp.111.104711. Epub 2012 Oct 25.
- Amsterdam JD, Shults J. Efficacy and safety of long-term fluoxetine versus lithium monotherapy of bipolar II disorder: a randomized, double-blind, placebo-substitution study. Am J Psychiatry. 2010 Jul;167(7):792-800. doi: 10.1176/appi.ajp.2009.09020284. Epub 2010 Apr 1.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fluoxetine | Small molecule | 10 mg | — |
| Subject | Fluoxetine | Small molecule | 40 mg | — |
| Subject | Lithium | Unknown | 300 mg | — |
| Subject | Lithium | Unknown | 1200 mg | — |