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

NCT00078754 | Completed Phase 2 Results DMC

• 2 other identifiers: R01MH066984DATR A5-ETMA
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Overt Aggression Scale-Modified for Outpatient Use (OAS-M)

  OAS-M is a validated instrument that measures aggression. Anti-aggressive effect of the drug/placebo was measured by the aggression score from OAS-M. Possible scores for aggression range from 0 (no aggression) to infinity (because the score is calculated by the number of times an aggressive behavior occurred, which theoretically has no possible maximum). Therefore the bigger number, the worse anti-aggression effect, thus the worse outcome. In each weekly visit, OAS-M score was calculated for the past week.

  Measured at Week 12

Secondary Outcomes (1)

• OAS-M

  Measured at Week 12

Study Arms (3)

A

EXPERIMENTAL

Participants will to receive treatment with fluoxetine for 12 weeks

Drug: Fluoxetine

B

EXPERIMENTAL

Participants will to receive treatment with divalproex for 12 weeks

Drug: Divalproex

C

PLACEBO COMPARATOR

Participants will to receive treatment with placebo for 12 weeks

Drug: Placebo

Interventions

Fluoxetine DRUG

Fluoxetine capsules by mouth, up to 60 mg daily

A

Divalproex DRUG

Divalproex ER capsules by mouth, up to 3000 mg daily

B

Placebo DRUG

Placebo capsules by mouth, up to 8 capsules daily

C

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosis of Intermittent Explosive Disorder (IED)
• In good physical health
• Overt Aggression Scale-Modified (OAS-M) score of 15 or higher at screening
• Willing and able to comply with the study requirements

You may not qualify if:

• Life history of bipolar disorder, schizophrenia, organic mental syndrome, or mental retardation
• Current major depressive disorder, with a Hamilton Depression (HAM-D) Scale score higher than 18
• Current alcohol or drug abuse or dependence
• Active medical conditions that will interfere with the study
• Thymoleptic or neuroleptic treatments
• Presence of the following serious and active medical conditions: demyelinating or progressive degenerative disorders; central nervous system infection; progressive degenerative neurological disorder; ischemic heart disease; respiratory, renal, or liver disease; Type I diabetes; malignant neoplasm; hyper- or hypo-coagulopathy; Acquired Immune Deficiency Syndrome (AIDS); or seizure disorder. Participants with a history of more than two febrile seizures prior to 1 year of age are eligible.
• Chronic, ongoing treatment with the following classes of medications: antidepressants, neuroleptics, mood stabilizers, antianxiety agents, hypnotics, narcotics or synthetic narcotics, barbiturates, stimulants, anti-migraine agents, anti-epileptics, non-beta-blocking or Ca-channel blocking anti-arrhythmic agents prescribed to treat cardiac arrhythmia, anticoagulants, immunomodulators, anti-neoplastic agents, or HIV antiviral agents
• Ongoing psychotherapeutic treatment for the treatment of IED or anger that was started less than 3 months before study entry
• Hypersensitivity to fluoxetine or divalproex
• Pregnancy

Sponsors & Collaborators

• University of Chicago: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

The University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Disruptive, Impulse Control, and Conduct Disorders

Interventions

Fluoxetine; Valproic Acid

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Pentanoic Acids; Valerates; Acids, Acyclic; Carboxylic Acids; Fatty Acids, Volatile; Fatty Acids; Lipids

Limitations and Caveats

Most participants did not have stable OAS-M Aggression scores from screening to randomization. Note that this was not a requirement for this study; only that OAS-Aggression scores were 15 or higher at screening.

Results Point of Contact

• Title: Dr. Emil F. Coccaro, MD
• Organization: The University of Chicago

ecoccaro@yoda.bsd.uchicago.edu

773-834-4083

Study Officials

• Emil F. Coccaro, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2004
• First Posted: March 8, 2004
• Study Start: May 1, 2003
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: April 27, 2021
• Results First Posted: December 31, 2014

Record last verified: 2021-04

Locations

US (1)