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| 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: | Treatment, Single Blind, Placebo Control |
| Official Title: | Neurobiology/Treatment of Obsessive-Compulsive Disorder |
| Study Start Date: | September 1992 |
| Estimated Study Completion Date: | 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 to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
-
Patients must have:
Either TS-spectrum or non-TS-spectrum obsessive-compulsive disorder (OCD).
Contacts and 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 | |
| Principal Investigator: | Wayne Goodman, MD |
More Information
| Study ID Numbers: | MH45802, DSIR |
| Study First Received: | November 2, 1999 |
| Last Updated: | December 6, 2005 |
| ClinicalTrials.gov Identifier: | NCT00000373 History of Changes |
| Health Authority: | United States: Federal Government |
|
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 |
|
Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Olanzapine Psychotropic Drugs Antiemetics Pathologic Processes Mental Disorders Therapeutic Uses Antidepressive Agents, Second-Generation Obsessive-Compulsive Disorder Antidepressive Agents |
Disease Tranquilizing Agents Gastrointestinal Agents Central Nervous System Depressants Antipsychotic Agents Serotonin Uptake Inhibitors Pharmacologic Actions Fluoxetine Serotonin Agents Anxiety Disorders Autonomic Agents Peripheral Nervous System Agents Central Nervous System Agents |
