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Treatment of Obsessive-Compulsive Disorder

This study has been completed.
Study NCT00000373.   Last updated on December 6, 2005.   Information provided by National Institute of Mental Health (NIMH)

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Descriptive Information Fields
Brief Title  Treatment of Obsessive-Compulsive Disorder
Official Title  Neurobiology/Treatment of Obsessive-Compulsive Disorder
Brief Summary

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).

Detailed Description

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).

Study Phase
Study Type  Interventional
Study Design  Treatment, Single Blind, Placebo Control
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Obsessive-Compulsive Disorder
Intervention  Drug: Fluoxetine
Drug: Olanzapine
MEDLINE PMIDs 15023585
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment 
Start Date  September 1992
Completion Date April 2000
Eligibility Criteria 

Inclusion Criteria:

-

Patients must have:

Either TS-spectrum or non-TS-spectrum obsessive-compulsive disorder (OCD).

Gender Both
Ages 14 Years to 70 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00000373
Organization ID MH45802
Secondary IDs †† DSIR
Study Sponsor  National Institute of Mental Health (NIMH)
Collaborators ††
Investigators 
Principal Investigator:     Wayne Goodman, MD        
Information Provided By National Institute of Mental Health (NIMH)
Verification Date December 2005
First Received Date  November 2, 1999
Last Updated Date December 6, 2005

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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