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

Primary Purpose

Intermittent Explosive Disorder

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Fluoxetine
Divalproex
Placebo
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intermittent Explosive Disorder

Eligibility Criteria

21 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The University of Chicago

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

A

B

C

Arm Description

Participants will to receive treatment with fluoxetine for 12 weeks

Participants will to receive treatment with divalproex for 12 weeks

Participants will to receive treatment with placebo for 12 weeks

Outcomes

Primary Outcome Measures

Overt Aggression Scale-Modified for Outpatient Use (OAS-M)
OAS-M is a validated instrument that measures aggression. Anti-aggressive effect of the drug/placebo was measured by the aggression score from OAS-M. Possible scores for aggression range from 0 (no aggression) to infinity (because the score is calculated by the number of times an aggressive behavior occurred, which theoretically has no possible maximum). Therefore the bigger number, the worse anti-aggression effect, thus the worse outcome. In each weekly visit, OAS-M score was calculated for the past week.

Secondary Outcome Measures

OAS-M
Overt Aggression Scale Modified for Outpatient Use. Minimum value = 0 Maximum value = Infinity. Higher scores means worse outcome.

Full Information

First Posted
March 5, 2004
Last Updated
April 26, 2021
Sponsor
University of Chicago
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00078754
Brief Title
A Comparison of Fluoxetine and Divalproex for the Treatment of Intermittent Explosive Disorder
Official Title
Fluoxetine and Divalproex: Treatment Correlates in IED
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
May 2003 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will compare the medications fluoxetine (Prozac®) and divalproex (Depakote®) for the treatment of aggressive behavior in individuals with Intermittent Explosive Disorder (IED).
Detailed Description
IED is a condition characterized by a failure to resist aggressive impulses. IED is a behavioral 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intermittent Explosive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Participants will to receive treatment with fluoxetine for 12 weeks
Arm Title
B
Arm Type
Experimental
Arm Description
Participants will to receive treatment with divalproex for 12 weeks
Arm Title
C
Arm Type
Placebo Comparator
Arm Description
Participants will to receive treatment with placebo for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Fluoxetine
Intervention Description
Fluoxetine capsules by mouth, up to 60 mg daily
Intervention Type
Drug
Intervention Name(s)
Divalproex
Intervention Description
Divalproex ER capsules by mouth, up to 3000 mg daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo capsules by mouth, up to 8 capsules daily
Primary Outcome Measure Information:
Title
Overt Aggression Scale-Modified for Outpatient Use (OAS-M)
Description
OAS-M is a validated instrument that measures aggression. Anti-aggressive effect of the drug/placebo was measured by the aggression score from OAS-M. Possible scores for aggression range from 0 (no aggression) to infinity (because the score is calculated by the number of times an aggressive behavior occurred, which theoretically has no possible maximum). Therefore the bigger number, the worse anti-aggression effect, thus the worse outcome. In each weekly visit, OAS-M score was calculated for the past week.
Time Frame
Measured at Week 12
Secondary Outcome Measure Information:
Title
OAS-M
Description
Overt Aggression Scale Modified for Outpatient Use. Minimum value = 0 Maximum value = Infinity. Higher scores means worse outcome.
Time Frame
Measured at Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emil F. Coccaro, MD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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