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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) |
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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 |
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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
Expected Total Enrollment: 144
Study start: May 2003;
Study 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:
Exclusion Criteria:
Location and Contact Information
More Information
U.S. National Library of Medicine, Contact NLM Customer Service | ||||||||||||||
National Institutes of Health, Department of Health & Human Services | ||||||||||||||
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