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Treatment of Obsessive-Compulsive Disorder
This study has been completed.
Study NCT00000373   Information provided by National Institute of Mental Health (NIMH)
First Received: November 2, 1999   Last Updated: December 6, 2005   History of Changes

November 2, 1999
December 6, 2005
September 1992
 
 
 
Complete list of historical versions of study NCT00000373 on ClinicalTrials.gov Archive Site
 
 
 
Treatment of Obsessive-Compulsive Disorder
Neurobiology/Treatment of Obsessive-Compulsive Disorder

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).

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).

 
Interventional
Treatment, Single Blind, Placebo Control
Obsessive-Compulsive Disorder
  • Drug: Fluoxetine
  • Drug: Olanzapine
 
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.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
April 2000
 

Inclusion Criteria:

-

Patients must have:

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

Both
14 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00000373
 
MH45802, DSIR
National Institute of Mental Health (NIMH)
 
Principal Investigator: Wayne Goodman, MD
National Institute of Mental Health (NIMH)
December 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP