Repetitive Behavior Disorders in People With Severe Mental Retardation
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|ClinicalTrials.gov Identifier: NCT00491478|
Recruitment Status : Unknown
Verified May 2003 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Recruitment status was: Recruiting
First Posted : June 26, 2007
Last Update Posted : June 26, 2007
|Condition or disease||Intervention/treatment||Phase|
|Mental Retardation Stereotyped Behavior Self-Injurious Behavior Compulsive Behavior||Drug: sertraline||Phase 3|
Abnormal repetitive behaviors (odd or inappropriate movements, self-injury, and compulsions) are among the aberrant behaviors exhibited by individuals with mental retardation. However, little is known about their pathobiology and treatments are largely unconfirmed by controlled trials. For example, few controlled studies have examined the efficacy of pharmacological treatment of abnormal repetitive behavior in individuals with mental retardation.
This trial is part of a larger project designed to elucidate the neurobiological bases of repetitive behavior disorders and to develop rational, safe, and effective pharmacological treatments. Thus far, the project has established a pathophysiological basis for stereotyped behavior disorder, demonstrated the role of central dopamine deficiency in stereotyped behavior disorder, and provided evidence of the efficacy of both 5-HT uptake inhibitors and atypical antipsychotics in treating stereotyped behaviors.
There is currently little information to guide the clinician in deciding which drug class may be more effective for which abnormal repetitive behaviors and for which individuals. Moreover, little work has attempted to identify variables that may predict differential treatment response. This trial will assess the relative efficacy of an SSRI and an atypical antipsychotic across multiple categories of abnormal repetitive behaviors.
|Study Type :||Interventional (Clinical Trial)|
|Intervention Model:||Factorial Assignment|
|Official Title:||Stereotypies and Mental Retardation: Neurobiological Basis|
|Study Start Date :||September 1992|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00491478
|Contact: Mark Lewis, PhDfirstname.lastname@example.org|
|United States, Florida|
|Department of Psychiatry||Recruiting|
|Gainesville, Florida, United States, 32610-0256|
|United States, North Carolina|
|Western Carolina Center||Recruiting|
|Morganton, North Carolina, United States, 28655|
|Contact: James W. Bodfish, PhD 828-483-6518 Jim.Bodfish@westerncarolinacenter.org|
|Principal Investigator:||Mark Lewis, PhD||University of Florida|