Completed

Fluoxetine and Divalproex: Treatment Correlates in IED

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Fluoxetine

+ Divalproex

+ Placebo

Drug
Who is being recruted

Mental Disorders

+ Disruptive, Impulse Control, and Conduct Disorders

From 21 to 55 Years
+14 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2
Interventional
Study Start: May 2003
See protocol details

Summary

Principal SponsorUniversity of Chicago
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2003

Actual date on which the first participant was enrolled.

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.

Official TitleFluoxetine and Divalproex: Treatment Correlates in IED
NCT00078754
Principal SponsorUniversity of Chicago
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

90 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 21 to 55 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Mental DisordersDisruptive, Impulse Control, and Conduct Disorders

Criteria

4 inclusion criteria required to participate
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
10 exclusion criteria prevent from participating
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
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Participants will to receive treatment with fluoxetine for 12 weeks

Group II

Experimental
Participants will to receive treatment with divalproex for 12 weeks

Group III

Placebo
Participants will to receive treatment with placebo for 12 weeks

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

The University of Chicago

Chicago, United StatesOpen The University of Chicago in Google Maps
CompletedOne Study Center