Overview

Treatment of Obsessive-Compulsive Disorder

Status:
Completed
Trial end date:
2003-07-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Florida
Collaborator:
National Institute of Mental Health (NIMH)
Treatments:
Antipsychotic Agents
Fluoxetine
Fluvoxamine
Haloperidol
Olanzapine
Serotonin
Serotonin Uptake Inhibitors
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.