Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Treatment of Obsessive-Compulsive Disorder

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

Tracking Information
First Submitted Date  ICMJE November 2, 1999
First Posted Date  ICMJE November 3, 1999
Last Update Posted Date November 27, 2013
Study Start Date  ICMJE September 1992
Actual Primary Completion Date January 2003   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 26, 2013)
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 ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Obsessive-Compulsive Disorder
Official Title  ICMJE Neurobiology/Treatment of Obsessive-Compulsive Disorder
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.

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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Obsessive-Compulsive Disorder
Intervention  ICMJE
  • Drug: olanzapine + fluoxetine
  • Drug: placebo + fluoxetine
Study Arms  ICMJE
  • 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.
    Intervention: 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.
    Intervention: Drug: olanzapine + fluoxetine
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 26, 2013)
74
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE July 2003
Actual Primary Completion Date January 2003   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 14 Years to 70 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00000373
Other Study ID Numbers  ICMJE R01MH045802( U.S. NIH Grant/Contract )
R01MH045802 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Florida
Study Sponsor  ICMJE University of Florida
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: Wayne Goodman, MD University of Florida
PRS Account University of Florida
Verification Date November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP