Treatment of Obsessive-Compulsive Disorder

Sponsor

University of Florida (Other)

Overall Status

Completed

CT.gov ID

NCT00000373

Collaborator

National Institute of Mental Health (NIMH) (NIH)

Enrollment

Locations

Arms

129.9

Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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).

Study Design

Study Type:

Interventional

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 :

Sep 1, 1992

Actual Primary Completion Date :

Jan 1, 2003

Actual Study Completion Date :

Jul 1, 2003

Arms and Interventions

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

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

Drug: olanzapine + fluoxetine

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Psychiatric Specialty Clinic, Shands Hospital at the University of Florida	Gainesville	Florida	United States	32608
2	University of Florida Behavioral Health Mandarin Clinic	Jacksonville	Florida	United States	32257