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A Comparison of Fluoxetine and Divalproex for the Treatment of Intermittent Explosive Disorder (IED) Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on A Comparison of Fluoxetine and Divalproex for the Treatment of Intermittent Explosive Disorder (IED) conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. A Comparison of Fluoxetine and Divalproex for the Treatment of Intermittent Explosive Disorder (IED) Clinical research trials and A Comparison of Fluoxetine and Divalproex for the Treatment of Intermittent Explosive Disorder (IED) healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including A Comparison of Fluoxetine and Divalproex for the Treatment of Intermittent Explosive Disorder (IED). A Comparison of Fluoxetine and Divalproex for the Treatment of Intermittent Explosive Disorder (IED) Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a A Comparison of Fluoxetine and Divalproex for the Treatment of Intermittent Explosive Disorder (IED) clinical trial. Test subjects typically receive the most effective healthcare possible for their A Comparison of Fluoxetine and Divalproex for the Treatment of Intermittent Explosive Disorder (IED) condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Comparison of Fluoxetine and Divalproex for the Treatment of Intermittent Explosive Disorder (IED)  A Comparison of Fluoxetine and Divalproex for the Treatment of Intermittent Explosive Disorder (IED)
A Comparison of Fluoxetine and Divalproex for the Treatment of Intermittent Explosive Disorder (IED)
For Condition: Intermittent Explosive Disorder
Status: Recruiting
Sponsor(s): National Institute of Mental Health (NIMH) ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: 21 Years/55 Years
Genders: Both
Protocol Entry 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
Total Enrollment: 144
Location and Contact Information:
Overall Study Official:
EmilCoccaro, Principal Investigator, The University of Chicago
The University of Chicago *Recruiting*
Chicago, Illinois, 60637
United States
Recruiting Marilynn Powell 773-834-0848
Additional Information:
Study ID Numbers: MH66984-01;
Study Start Date: May 2003
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00078754
Other Intermittent Explosive Disorder Studies:
1. A Comparison of Fluoxetine and Divalproex for the Treatment of Intermittent Explosive Disorder (IED)
Related Studies:
Other Intermittent Explosive Disorder Clinical Trials
Other Illinois Clinical Trials
Other Chicago Clinical Trials
A Comparison of Fluoxetine and Divalproex for the Treatment of Intermittent Explosive Disorder (IED)
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