drugset / Trial / NCT00427128
Prozac Treatment of Major Depression: Discontinuation Study
Phase 4
Completed
627 enrolled
New York State Psychiatric Institute
Massachusetts General Hospital · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
This study randomized two stratifications of acute phase MDD SSRI responders, categorized as having either "true drug" response or "placebo response" pattern, to continuation with SSRI vs placebo in a double-blind trial to determine if stratification category predicted continuation outcome.
Timeline
- Start
- 1995-11
- Primary completion
- —
- Completion
- 2003-03
Publications
- Results McGrath PJ, Stewart JW, Quitkin FM, Chen Y, Alpert JE, Nierenberg AA, Fava M, Cheng J, Petkova E. Predictors of relapse in a prospective study of fluoxetine treatment of major depression. Am J Psychiatry. 2006 Sep;163(9):1542-8. doi: 10.1176/ajp.2006.163.9.1542.
- Posternak MA, Baer L, Nierenberg AA, Fava M. Response rates to fluoxetine in subjects who initially show no improvement. J Clin Psychiatry. 2011 Jul;72(7):949-54. doi: 10.4088/JCP.10m06098. Epub 2011 May 31.
- Yang H, Sinicropi-Yao L, Chuzi S, Youn SJ, Clain A, Baer L, Chen Y, McGrath PJ, Fava M, Papakostas GI. Residual sleep disturbance and risk of relapse during the continuation/maintenance phase treatment of major depressive disorder with the selective serotonin reuptake inhibitor fluoxetine. Ann Gen Psychiatry. 2010 Feb 26;9:10. doi: 10.1186/1744-859X-9-10.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fluoxetine | Small molecule | 20 mg | — |
| Subject | Fluoxetine | Small molecule | 80 mg | — |