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Treatment of Obsessive-Compulsive Disorder - Article


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Fluoxetine

Prozac; Prozac Weekly; Sarafem


Clinical Trial: Treatment of Obsessive-Compulsive Disorder

This study has been completed.

Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)

Purpose

The purpose of this study is to find the best treatment for Tourette's Syndrome (TS)-spectrum obsessive-compulsive disorder (OCD), which includes symptoms of TS, e.g., repeated and involuntary body movements (tics).

There are 2 parts to this study: In Part 1, patients are placed into 1 of 2 groups based on type of OCD, determined by medical history and family member interviews. In Part 2, patients are treated with fluvoxamine (FVX) for 8 weeks. If patients do not respond to FVX alone, either haloperidol or an inactive placebo will be added to the FVX regimen; patients will take this drug combination for 4 weeks. Patients will be monitored throughout the trial.

You may be eligible for this study if you: Are 16 - 70 years old. Have obsessive-compulsive disorder (OCD).

Condition Treatment or Intervention
Obsessive-Compulsive Disorder
 Drug: Fluoxetine
 Drug: Olanzapine

MedlinePlus related topics:  Obsessive-Compulsive Disorder

Study Type: Interventional
Study Design: Treatment, Single Blind, Placebo Control

Official Title: Neurobiology/Treatment of Obsessive-Compulsive Disorder

Further Study Details: 

Study start: September 1992;  Study completion: April 2000

To advance the neurobiology and treatment of obsessive-compulsive disorder (OCD) by focusing on Tourette's Syndrome (TS)-spectrum OCD as a possible homogeneous form of OCD, and investigating the relevance of intact 5-HT function to the mechanism of anti-OC drug action. The validity of TS-spectrum OCD as a distinct subtype is assessed using a detailed clinical, family, drug treatment response profile in adult OCD patients.

In Study I, patients are divided prospectively into 2 putative subtypes (TS-spectrum and non-TS-spectrum OCD) on the basis of clinical history and direct, structured interviews of family members (approx. 400 interviews). In Study II, patients enter an 8-week single-blind trial with the potent and selective 5-HT reuptake inhibitor fluoxetine (FX). Patients with an incomplete response to FX alone (approximately 64 patients) are randomized to a 4-week double-blind trial of FX in combination with the dopamine (DA) 2 antagonist olanzapine (OLA) or placebo (PLA).

Eligibility

Ages Eligible for Study:  14 Years   -   70 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

    Patients must have: Either TS-spectrum or non-TS-spectrum obsessive-compulsive disorder (OCD).


    Location Information


    Florida
          Psychiatric Specialty Clinic, Shands Hospital at the University of Florida, Gainesville,  Florida,  32608,  United States

          University of Florida Behavioral Health Mandarin Clinic, Jacksonville,  Florida,  32257,  United States

    Study chairs or principal investigators

    Wayne Goodman, MD,  Principal Investigator

    More Information

    Publications

    Shapira NA, Ward HE, Mandoki M, Murphy TK, Yang MC, Blier P, Goodman WK. A double-blind, placebo-controlled trial of olanzapine addition in fluoxetine-refractory obsessive-compulsive disorder. Biol Psychiatry. 2004 Mar 1;55(5):553-5.

    Study ID Numbers:  MH45802
    Record last reviewed:  January 2005
    Last Updated:  January 26, 2005
    Record first received:  November 2, 1999
    ClinicalTrials.gov Identifier:  NCT00000373
    Health Authority: United States: Federal Government
    ClinicalTrials.gov processed this record on 2005-04-08


    Source: ClinicalTrials.gov
    Cache Date: April 9, 2005


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    Page Updated: October 1, 2005
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