Treatment of Obsessive-Compulsive Disorder
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ClinicalTrials.gov Identifier: NCT00000373 |
Recruitment Status :
Completed
First Posted : November 3, 1999
Last Update Posted : November 27, 2013
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Tracking Information | ||||
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First Submitted Date ICMJE | November 2, 1999 | |||
First Posted Date ICMJE | November 3, 1999 | |||
Last Update Posted Date | November 27, 2013 | |||
Study Start Date ICMJE | September 1992 | |||
Actual Primary Completion Date | January 2003 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
25% reduction in Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score from baseline [ Time Frame: Baseline, Week s 1, 2, 4, 6, 8, 10, 12, and 14 ] | |||
Original Primary Outcome Measures ICMJE | Not Provided | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE | Not Provided | |||
Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Treatment of Obsessive-Compulsive Disorder | |||
Official Title ICMJE | Neurobiology/Treatment of Obsessive-Compulsive Disorder | |||
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. |
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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). |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Single (Participant) Primary Purpose: Treatment |
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Condition ICMJE | Obsessive-Compulsive Disorder | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
74 | |||
Original Enrollment ICMJE | Not Provided | |||
Actual Study Completion Date ICMJE | July 2003 | |||
Actual Primary Completion Date | January 2003 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | 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. |
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Sex/Gender ICMJE |
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Ages ICMJE | 14 Years to 70 Years (Child, Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00000373 | |||
Other Study ID Numbers ICMJE | R01MH045802( U.S. NIH Grant/Contract ) R01MH045802 ( U.S. NIH Grant/Contract ) |
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Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | University of Florida | |||
Study Sponsor ICMJE | University of Florida | |||
Collaborators ICMJE | National Institute of Mental Health (NIMH) | |||
Investigators ICMJE |
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PRS Account | University of Florida | |||
Verification Date | November 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |