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Trial NCT00000373

Resource URI: http://static.linkedct.org/resource/trials/NCT00000373
linkedct:brief_title Treatment of Obsessive-Compulsive Disorder
linkedct:condition <http://static.linkedct.org/resource/condition/9124>
linkedct:criteria Inclusion Criteria: - Patients must have: Either TS-spectrum or non-TS-spectrum obsessive-compulsive disorder (OCD).
linkedct: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-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 (approx. 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).
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age 70 Years
linkedct:eligibility_minimum_age 14 Years
linkedct:end_date April 2000
linkedct:enrollment 0 (xsd:int)
linkedct:firstreceived_date November 2, 1999
linkedct:id NCT00000373
rdfs:label Trial NCT00000373
linkedct:lastchanged_date December 6, 2005
linkedct:lead_sponsor_agency National Institute of Mental Health (NIMH)
linkedct:location <http://static.linkedct.org/resource/location/171930>
linkedct:location <http://static.linkedct.org/resource/location/172305>
linkedct:nct_id NCT00000373
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title Neurobiology/Treatment of Obsessive-Compulsive Disorder
linkedct:org_study_id MH45802
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/60875>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000373>
linkedct:phase N/A
linkedct:reference <http://static.linkedct.org/resource/reference/21469>
linkedct:secondary_id DSIR
linkedct:source National Institute of Mental Health (NIMH)
linkedct:start_date September 1992
linkedct:study_design Treatment, Single Blind, Placebo Control
linkedct:study_type Interventional
linkedct: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. You may be eligible for this study if you: Are 16 - 70 years old. Have obsessive-compulsive disorder (OCD).
rdf:type linkedct:trials
linkedct:verification_date December 2005