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| Sponsored by: |
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 |
| 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 |
|
Tryptophan Fluvoxamine Olanzapine Tourette Syndrome Serotonin Haloperidol Fluoxetine |
Haloperidol decanoate Dopamine Anxiety Disorders Mental Disorders Gilles de la Tourette's syndrome Obsessive-Compulsive Disorder |
|
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Tranquilizing Agents Disease Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Gastrointestinal Agents Psychotropic Drugs Antiemetics Central Nervous System Depressants Antipsychotic Agents |
Serotonin Uptake Inhibitors Pharmacologic Actions Pathologic Processes Serotonin Agents Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Antidepressive Agents, Second-Generation Central Nervous System Agents Antidepressive Agents |
