We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Treatment of Obsessive-Compulsive Disorder

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000373
First Posted: November 3, 1999
Last Update Posted: November 27, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of Florida
  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.


Condition Intervention Phase
Obsessive-Compulsive Disorder Drug: olanzapine + fluoxetine Drug: placebo + fluoxetine Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Neurobiology/Treatment of Obsessive-Compulsive Disorder

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • 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 ]

Enrollment: 74
Study Start Date: September 1992
Study Completion Date: July 2003
Primary Completion Date: January 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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.

  Contacts and Locations
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


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
University of Florida
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Wayne Goodman, MD University of Florida
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00000373     History of Changes
Other Study ID Numbers: R01MH045802 ( U.S. NIH Grant/Contract )
First Submitted: November 2, 1999
First Posted: November 3, 1999
Last Update Posted: November 27, 2013
Last Verified: November 2013

Keywords provided by University of Florida:
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:
Disease
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Pathologic Processes
Personality Disorders
Mental Disorders
Anxiety Disorders
Olanzapine
Haloperidol
Antipsychotic Agents
Fluoxetine
Fluvoxamine
Serotonin Uptake Inhibitors
Serotonin
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
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