Treatment of Obsessive-Compulsive Disorder - Full Text View

Sponsor:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00000373

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	Intervention
Obsessive-Compulsive Disorder	Drug: Fluoxetine Drug: Olanzapine

Study Type:	Interventional
Study Design:	Masking: Single Blind Primary Purpose: Treatment
Official Title:	Neurobiology/Treatment of Obsessive-Compulsive Disorder

Resource links provided by NLM:

Genetics Home Reference related topics: Tourette syndrome

MedlinePlus related topics: Obsessive-Compulsive Disorder Tourette Syndrome

Drug Information available for: Serotonin Dopamine Dopamine hydrochloride Fluoxetine Fluoxetine hydrochloride Olanzapine

U.S. FDA Resources

Further study details as provided by National Institute of Mental Health (NIMH):

Study Start Date:	September 1992
Estimated Study Completion Date:	April 2000

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).

Eligibility

Ages Eligible for Study:	14 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

-

Patients must have:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000373

Locations

United States, Florida
Psychiatric Specialty Clinic, Shands Hospital at the University of Florida
Gainesville, Florida, United States, 32608
University of Florida Behavioral Health Mandarin Clinic
Jacksonville, Florida, United States, 32257

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

Wayne Goodman, MD

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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Koran LM, Bromberg D, Hornfeldt CS, Shepski JC, Wang S, Hollander E. Extended-release fluvoxamine and improvements in quality of life in patients with obsessive-compulsive disorder. Compr Psychiatry. 2010 Jul-Aug;51(4):373-9. Epub 2009 Dec 21.

ClinicalTrials.gov Identifier:	NCT00000373 History of Changes
Other Study ID Numbers:	MH45802, DSIR
Study First Received:	November 2, 1999
Last Updated:	December 6, 2005
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

Adolescence
Adult
Antipsychotic Agents
Dopamine Antagonists
Female
Fluvoxamine
Haloperidol
Human
Male
Middle Age
Obsessive-Compulsive Disorder

Placebos
Serotonin Uptake Inhibitors
Tourette Syndrome
Tryptophan
Drug Combinations
Antipsychotic Agents -- *therapeutic use
Fluvoxamine -- *therapeutic use
Haloperidol -- *therapeutic use
Obsessive-Compulsive Disorder -- *drug therapy
Obsessive-Compulsive Disorder -- physiopathology
Serotonin Uptake Inhibitors -- *therapeutic use

Additional relevant MeSH terms:

Obsessive-Compulsive Disorder
Anxiety Disorders
Mental Disorders
Fluoxetine
Serotonin Uptake Inhibitors
Olanzapine
Antipsychotic Agents
Dopamine Antagonists
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents

Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Tranquilizing Agents
Central Nervous System Depressants
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Dopamine Agents

ClinicalTrials.gov processed this record on February 13, 2012