Treatment of Obsessive-Compulsive Disorder
Information source: University of Florida
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Obsessive-Compulsive Disorder
Intervention: olanzapine + fluoxetine (Drug); placebo + fluoxetine (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: University of Florida Official(s) and/or principal investigator(s): Wayne Goodman, MD, Principal Investigator, Affiliation: University of Florida
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.
Clinical Details
Official title: Neurobiology/Treatment of Obsessive-Compulsive Disorder
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Primary outcome: 25% reduction in Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score from baseline
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
Minimum age: 14 Years.
Maximum age: 70 Years.
Gender(s): Both.
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.
Locations and Contacts
Psychiatric Specialty Clinic, Shands Hospital at the University of Florida, Gainesville, Florida 32608, United States
University of Florida Behavioral Health Mandarin Clinic, Jacksonville, Florida 32257, United States
Additional Information
Related publications: Shapira NA, Ward HE, Mandoki M, Murphy TK, Yang MC, Blier P, Goodman WK. A double-blind, placebo-controlled trial of olanzapine addition in fluoxetine-refractory obsessive-compulsive disorder. Biol Psychiatry. 2004 Mar 1;55(5):553-5.
Starting date: September 1992
Last updated: November 26, 2013
|