Official Title: “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).

Study Type: Interventional

Study Design: Treatment, Single Blind, Placebo Control

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).

Intervention(s) in this Clinical Trial

• Drug: Fluoxetine
• Drug: Olanzapine

Inclusion Criteria:

-

Patients must have:

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 14 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: National Institute of Mental Health (NIMH)

Overall Clinical Trial Officials and Contacts

Wayne Goodman, MD Principal Investigator   

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00000373

Study ID Number: MH45802

ClinicalTrials.gov Identifier: NCT00000373

Health Authority: United States: Federal Government