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NCT00078754 · ClinicalTrials.gov registry record · Phase 2
A Comparison of Fluoxetine and Divalproex for the Treatment of Intermittent Explosive Disorder
A Phase 2 study of Intermittent Explosive Disorder, sponsored by University of Chicago.
- Completed
- Registry status
- Phase 2
- Development phase
- 90
- Enrollment target
- 1
- Study location
NCT00078754: Completed Phase 2 study of Intermittent Explosive Disorder, sponsored by University of Chicago.
NCT00078754 is a Phase 2 study of Intermittent Explosive Disorder that has completed, run by University of Chicago. The registered enrollment target is 90 participants, above the 76-participant average among 3 other Intermittent Explosive Disorder trials with a reported enrollment target (18% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00078754, a Phase 2 study of Intermittent Explosive Disorder, has completed, sponsored by University of Chicago.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 90 participants
- Enrollment target
- 1
- Study location
Study 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).
Primary Outcome
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
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Fluoxetine
- DRUG Divalproex
Study Locations (1)
Illinois
- The University of Chicago - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2003-05 |
| Est. Completion | 2008-10 |
| Phase | Phase 2 |
What the finished NCT00078754 record still lists
NCT00078754 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, above the 76-participant average among 3 other Intermittent Explosive Disorder trials with a reported enrollment target (18% higher).
The record links to 1 condition, with Intermittent Explosive Disorder appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT00078754 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT00078754 about?
NCT00078754 is a clinical study titled "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).
What is the current status of trial NCT00078754?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 90 participants. The study started on 2003-05. Estimated completion is 2008-10.
What conditions does trial NCT00078754 study?
This clinical trial studies the following conditions: Intermittent Explosive Disorder.
What interventions are being tested in trial NCT00078754?
The interventions under investigation include: Placebo (DRUG), Fluoxetine (DRUG), Divalproex (DRUG).
Who is sponsoring clinical trial NCT00078754?
This trial is sponsored by University of Chicago, which has 796 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00078754 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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