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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2008 by National Institute of Mental Health (NIMH).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00078754
First received: March 5, 2004
Last updated: February 12, 2008
Last verified: February 2008
History of Changes

March 5, 2004
February 12, 2008
May 2003
May 2008   (final data collection date for primary outcome measure)
Anti-aggressive effects [ Time Frame: Measured at Week 12 ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00078754 on ClinicalTrials.gov Archive Site
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 ]
Not Provided
Not Provided
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A Comparison of Fluoxetine and Divalproex for the Treatment of Intermittent Explosive Disorder
Fluoxetine and Divalproex: Treatment Correlates in IED

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

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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Intermittent Explosive Disorder
  • 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
  • Experimental: A
    Participants will to receive treatment with fluoxetine for 12 weeks
    Intervention: Drug: Fluoxetine
  • Experimental: B
    Participants will to receive treatment with divalproex for 12 weeks
    Intervention: Drug: Divalproex
  • Placebo Comparator: C
    Participants will to receive treatment with placebo for 12 weeks
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
144
Not Provided
May 2008   (final data collection date for primary outcome measure)

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
Both
21 Years to 55 Years
No
Not Provided
United States
 
NCT00078754
R01 MH66984, DATR A5-ETMA
Yes
Emil Coccaro, MD, The University of Chicago
National Institute of Mental Health (NIMH)
Not Provided
Principal Investigator: Emil F. Coccaro, MD University of Chicago
National Institute of Mental Health (NIMH)
February 2008

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