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

Sponsor:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00078754

Purpose

This study will compare the medications fluoxetine (Prozac®) and divalproex (Depakote®) for the treatment of aggressive behavior in individuals with Intermittent Explosive Disorder (IED).

Condition	Intervention	Phase
Intermittent Explosive Disorder	Drug: Fluoxetine Drug: Divalproex Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Fluoxetine and Divalproex: Treatment Correlates in IED

Resource links provided by NLM:

Drug Information available for: Fluoxetine Fluoxetine hydrochloride

U.S. FDA Resources

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	144
Study Start Date:	May 2003
Estimated Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A Participants will to receive treatment with fluoxetine for 12 weeks	Drug: Fluoxetine Fluoxetine capsules by mouth, up to 60 mg daily
Experimental: B Participants will to receive treatment with divalproex for 12 weeks	Drug: Divalproex Divalproex ER capsules by mouth, up to 3000 mg daily
Placebo Comparator: C Participants will to receive treatment with placebo for 12 weeks	Drug: Placebo Placebo capsules by mouth, up to 8 capsules daily

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.

Eligibility

Ages Eligible for Study:	21 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00078754

Locations

United States, Illinois
The University of Chicago	Recruiting
Chicago, Illinois, United States, 60637
Contact: Cynthia Bogue, RN 773-834-8984 cbogue@yoda.bsd.uchicago.edu
Contact: Royce Lee, MD 773-834-5673 rlee@yoda.bsd.uchicago.edu
Principal Investigator: Emil F. Coccaro, MD
Sub-Investigator: Royce Lee, MD

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

Emil F. Coccaro, MD

University of Chicago

More Information

No publications provided

Responsible Party:	Emil Coccaro, MD, The University of Chicago
ClinicalTrials.gov Identifier:	NCT00078754 History of Changes
Other Study ID Numbers:	R01 MH66984, DATR A5-ETMA
Study First Received:	March 5, 2004
Last Updated:	February 12, 2008
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Impulse Control Disorders
Mental Disorders
Valproic Acid
Fluoxetine
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents

Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents

ClinicalTrials.gov processed this record on February 09, 2012