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Completed

NCT Number: NCT00078754

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

This study will compare the medications fluoxetine (Prozac®) and divalproex (Depakote®) for the treatment of aggressive behavior in individuals with Intermittent Explosive Disorder (IED).

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Key information

Conditions

Intermittent Explosive Disorder Disruptive, Impulse Control, and Conduct Disorders Mental Disorders

Age range

21 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The University of Chicago

Chicago, Illinois, 60637, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluoxetine

Drug

Fluoxetine capsules by mouth, up to 60 mg daily

divalproex

Drug

Divalproex ER capsules by mouth, up to 3000 mg daily

Placebo

Drug

Placebo capsules by mouth, up to 8 capsules daily

Primary outcomes

  1. Overt Aggression Scale-Modified for Outpatient Use (OAS-M)

    Time frame: Measured at Week 12

    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 outcomes

  1. OAS-M

    Time frame: Measured at Week 12

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

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Fluoxetine and Divalproex: Treatment Correlates in IED

Important dates

Study start
2003
Primary completion
2008
Study completion
2008
First posted
Mar 8, 2004
Registry last updated
Apr 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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