Obsessive-Compulsive Disorder Clinical Trial
Official title:
Neurobiology/Treatment of Obsessive-Compulsive Disorder
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.
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).
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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