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| Descriptive Information Fields | |||||
| Brief Title † | Treatment of Obsessive-Compulsive Disorder | ||||
| Official Title † | 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. You may be eligible for this study if you: Are 16 - 70 years old. Have obsessive-compulsive disorder (OCD). |
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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-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). |
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| Study Phase | |||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Single Blind, Placebo Control | ||||
| Primary Outcome Measure † | |||||
| Secondary Outcome Measure † | |||||
| Condition † | Obsessive-Compulsive Disorder | ||||
| Intervention † | Drug: Fluoxetine Drug: Olanzapine |
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| MEDLINE PMIDs | 15023585 | ||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Completed | ||||
| Enrollment † | |||||
| Start Date † | September 1992 | ||||
| Completion Date | April 2000 | ||||
| Eligibility Criteria † | Inclusion Criteria: - Patients must have: Either TS-spectrum or non-TS-spectrum obsessive-compulsive disorder (OCD). |
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| Gender | Both | ||||
| Ages | 14 Years to 70 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00000373 | ||||
| Organization ID | MH45802 | ||||
| Secondary IDs †† | DSIR | ||||
| Study Sponsor † | National Institute of Mental Health (NIMH) | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||
| Verification Date | December 2005 | ||||
| First Received Date † | November 2, 1999 | ||||
| Last Updated Date | December 6, 2005 | ||||