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
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
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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 2 |
| 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:
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
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:
|
Anticonvulsants Impulse Control Disorders Mental Disorders Valproic Acid Fluoxetine 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 May 21, 2013