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

Tracking Information

First Received Date ^ICMJE

March 5, 2004

Last Updated Date

February 12, 2008

Start Date ^ICMJE

May 2003

Estimated Primary Completion Date

May 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Anti-aggressive effects [ Time Frame: Measured at Week 12 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00078754 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Treatment response, assessed as a function of the severity of lifetime aggressiveness of the participant and as a function of the pretreatment status of the central 5-HT receptor system [ Time Frame: Measured at Week 12 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Fluoxetine and Divalproex: Treatment Correlates in IED

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).

Detailed Description

IED is a condition characterized by a failure to resist aggressive impulses. It is a vaguely defined condition for which effective treatments have not been identified. Research suggests that serotonin (5-HT), a chemical that helps regulate mood and emotions, may play a role in the response to pharmacological IED treatments. This study will examine the relationship between 5-HT receptors and response to treatment with fluoxetine or divalproex. In addition, this study will examine people with IED and those without the condition to determine whether there are differences in their 5-HT receptor and transporter systems.

Participants in this study will be randomly assigned to receive either fluoxetine, divalproex, or placebo for 12 weeks. Scale ratings will be used to assess the aggression levels of participants. Biologic evaluations of the 5-HT system will be conducted throughout the study.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Intermittent Explosive Disorder

Intervention ^ICMJE

Drug: Fluoxetine
Drug: Divalproex
Drug: Placebo

Study Arms / Comparison Groups

Experimental: Participants will to receive treatment with fluoxetine for 12 weeks
Experimental: Participants will to receive treatment with divalproex for 12 weeks
Placebo Comparator: Participants will to receive treatment with placebo for 12 weeks

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

144

Completion Date

April 2008

Estimated Primary Completion Date

May 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

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

Gender

Both

Ages

21 Years to 55 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00078754

Responsible Party

Emil Coccaro, MD, The University of Chicago

Study ID Numbers ^ICMJE

R01 MH66984, DATR A5-ETMA

Study Sponsor ^ICMJE

National Institute of Mental Health (NIMH)

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Emil F. Coccaro, MD

University of Chicago

Information Provided By

National Institute of Mental Health (NIMH)

Verification Date

February 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP