MedTrace Logo

A Comparison of Fluoxetine and Divalproex for the Treatment of Intermittent Explosive Disorder

NCT00078754 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2021-04-27

Study results available
· View outcomes & findings →

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).

Conditions

  • Intermittent Explosive Disorder

Interventions

DRUG

Fluoxetine

Fluoxetine capsules by mouth, up to 60 mg daily

DRUG

Divalproex

Divalproex ER capsules by mouth, up to 3000 mg daily

DRUG

Placebo

Placebo capsules by mouth, up to 8 capsules daily

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • University of Chicago

    lead OTHER

Principal Investigators

  • Emil F. Coccaro, MD · University of Chicago

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-05-31
Primary Completion
2008-10-31
Completion
2008-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00078754 on ClinicalTrials.gov