drugset / Trial / NCT00078754
A Comparison of Fluoxetine and Divalproex for the Treatment of Intermittent Explosive Disorder
Phase 2
Completed
90 enrolled
University of Chicago
National Institute of Mental Health (NIMH) · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
This study will compare the medications fluoxetine (Prozac®) and divalproex (Depakote®) for the treatment of aggressive behavior in individuals with Intermittent Explosive Disorder (IED).
Timeline
- Start
- 2003-05
- Primary completion
- 2008-10
- Completion
- 2008-10
Outcome
Missed primary endpoint
registry analysis (unspecified test); Group A - Fluoxetine Drug vs Group B - Divalproex Drug vs Group C - Placebo; p = 0.622; ANCOVA NCT00078754 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Divalproex Sodium | Small molecule | 3000 mg | Oral |
| Subject | Fluoxetine | Small molecule | 60 mg | Oral |