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Treatment of Obsessive-Compulsive Disorder

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ClinicalTrials.gov Identifier: NCT00000373
Recruitment Status : Completed
First Posted : November 3, 1999
Last Update Posted : November 27, 2013
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of Florida

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Obsessive-Compulsive Disorder Drug: olanzapine + fluoxetine Drug: placebo + fluoxetine Phase 4

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-hydroxytryptamine (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 (approximately 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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Neurobiology/Treatment of Obsessive-Compulsive Disorder
Study Start Date : September 1992
Actual Primary Completion Date : January 2003
Actual Study Completion Date : July 2003

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: olanzapine + fluoxetine
The specific aim was to determine whether combined treatment with fluoxetine plus olanzapine would be more effective than fluoxetine plus placebo in treating OCD subjects who were partial or nonresponders to a prospective, 8-week, open-label trial of fluoxetine.
Drug: placebo + fluoxetine
Placebo Comparator: placebo + fluoxetine
The specific aim was to determine whether combined treatment with fluoxetine plus olanzapine would be more effective than fluoxetine plus placebo in treating OCD subjects who were partial or nonresponders to a prospective, 8-week, open-label trial of fluoxetine.
Drug: olanzapine + fluoxetine

Primary Outcome Measures :
  1. 25% reduction in Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score from baseline [ Time Frame: Baseline, Week s 1, 2, 4, 6, 8, 10, 12, and 14 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria required that subjects, ages 14-70 years, have at least a 1-year duration of a current Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) principal diagnosis of OCD. Furthermore, the OCD had to be defined by a rating of "moderate" or greater on the global severity item of the Clinical Global Impressions (CGI) scale and have a Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score of 19 or greater.

Exclusion criteria included primary depression, schizophrenia, or other psychotic disorders; active bipolar disorder; abuse of alcohol or other significant substance within 6 months; increased risk of seizures or history of neurosurgery, encephalitis, or significant head trauma; or a significant medical condition, such as heart, liver, or renal disease. Subjects with an intelligence quotient of less than 80 as determined with the Kaufman Brief Intelligence Test (Kaufman and Kaufman 1990) were excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000373

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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
University of Florida
National Institute of Mental Health (NIMH)
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Principal Investigator: Wayne Goodman, MD University of Florida
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00000373    
Other Study ID Numbers: R01MH045802 ( U.S. NIH Grant/Contract )
R01MH045802 ( U.S. NIH Grant/Contract )
First Posted: November 3, 1999    Key Record Dates
Last Update Posted: November 27, 2013
Last Verified: November 2013
Keywords provided by University of Florida:
Antipsychotic Agents
Dopamine Antagonists
Middle Age
Obsessive-Compulsive Disorder
Serotonin Uptake Inhibitors
Tourette Syndrome
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:
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Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Pathologic Processes
Personality Disorders
Mental Disorders
Anxiety Disorders
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors