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A Comparison of Fluoxetine and Divalproex for the Treatment of Intermittent Explosive Disorder (IED) - Article


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Fluoxetine

Prozac; Prozac Weekly; Sarafem


Clinical Trial: A Comparison of Fluoxetine and Divalproex for the Treatment of Intermittent Explosive Disorder (IED)

This study is currently recruiting patients.

Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)

Purpose

The purpose of this study is to compare the medications fluoxetine and divalproex for the treatment of impulsive aggressive behavior in individuals with Intermittent Explosive Disorder (IED). This study will also determine whether the severity of aggressiveness in a person influences his or her response to treatment.

Condition Treatment or Intervention Phase
Intermittent Explosive Disorder
 Drug: Fluoxetine
 Drug: Divalproex
Phase II

MedlinePlus related topics:  Mental Health

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Official Title: Fluoxetine and Divalproex: Treatment Correlates in IED

Further Study Details: 

Expected Total Enrollment:  144

Study start: May 2003;  Expected completion: April 2008

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   -   55 Years,  Genders Eligible for Study:  Both

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 Immunune 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, barbituates, 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

Location and Contact Information


Illinois
      The University of Chicago, Chicago,  Illinois,  60637,  United States; Recruiting
Marilynn Powell, MA  773-834-0848    mpowell@yoda.bsd.uchicago.edu 
Royce Lee, MD  773-834-5673    rlee@yoda.bsd.uchicago.edu 
Emil F. Coccaro, MD,  Principal Investigator
Royce Lee, MD,  Sub-Investigator

Study chairs or principal investigators

Emil F. Coccaro, MD,  Principal Investigator,  The University of Chicago   

More Information

Study ID Numbers:  MH66984-01
Record last reviewed:  March 2004
Last Updated:  October 13, 2004
Record first received:  March 5, 2004
ClinicalTrials.gov Identifier:  NCT00078754
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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October 11, 2008



Page Updated: October 1, 2005
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