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Sponsored by: |
National Institute of Mental Health (NIMH) |
Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00078754 |
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 |
Drug Information available for: | Fluoxetine Fluoxetine hydrochloride |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Fluoxetine and Divalproex: Treatment Correlates in IED |
Estimated Enrollment: | 144 |
Study Start Date: | May 2003 |
Estimated Study Completion Date: | April 2008 |
Estimated Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
A: Experimental
Participants will to receive treatment with fluoxetine for 12 weeks
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Drug: Fluoxetine
Fluoxetine capsules by mouth, up to 60 mg daily
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B: Experimental
Participants will to receive treatment with divalproex for 12 weeks
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Drug: Divalproex
Divalproex ER capsules by mouth, up to 3000 mg daily
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C: Placebo Comparator
Participants will to receive treatment with placebo for 12 weeks
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Drug: Placebo
Placebo capsules by mouth, up to 8 capsules daily
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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.
Ages Eligible for Study: | 21 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Principal Investigator: | Emil F. Coccaro, MD | University of Chicago |
Responsible Party: | The University of Chicago ( Emil Coccaro, MD ) |
Study ID Numbers: | R01 MH66984, DATR A5-ETMA |
First Received: | March 5, 2004 |
Last Updated: | February 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00078754 |
Health Authority: | United States: Federal Government |
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