CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 90 enrolled
Drug / intervention
Fluoxetine +2 moredrug
Likely dose
Fluoxetine up to 60 mg daily orally; Divalproex ER up to 3000 mg daily orallyAI-extracted
Key inclusion· 4
  • ✓Diagnosis of Intermittent Explosive Disorder (IED)
  • ✓Overt Aggression Scale-Modified (OAS-M) score of 15 or higher at screening
  • ✓In good physical health
  • ✓Willing and able to comply with the study requirements
Key exclusion· 8
  • ✕Life history of bipolar disorder, schizophrenia, organic mental syndrome, or mental retardation
  • ✕Current major depressive disorder with HAM-D score higher than 18
  • ✕Current alcohol or drug abuse or dependence
  • ✕Active medical conditions that will interfere with the study

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00078754
NCT00078754Phase 2Completed
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Fluoxetine and Divalproex: Treatment Correlates in IED

University of Chicago·interventional·Posted Mar 8, 2004·Updated Apr 27, 2021

In Brief

A Phase 2 clinical trial evaluating Fluoxetine, Divalproex, and 1 other intervention for Intermittent Explosive Disorder. Completed, enrolled 90 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIntermittent Explosive Disorder
CountriesUnited States
CollaboratorsNational Institute of Mental Health (NIMH)

Timeline

Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 8, 2004
Enrollment StartMay 1, 2003
Primary CompletionOct 1, 2008
TodayJul 2, 2026
Enrollment to primary: 5.4 yearsPosted 22.3 years ago

Interventions

Fluoxetinedrug

Fluoxetine capsules by mouth, up to 60 mg daily

Divalproexdrug

Divalproex ER capsules by mouth, up to 3000 mg daily

Placebodrug

Placebo capsules by mouth, up to 8 capsules daily