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Sponsored by: |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
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Information provided by: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
ClinicalTrials.gov Identifier: | NCT00491478 |
Repetitive behavior disorders are prevalent among people with severe mental retardation. These disorders can interfere significantly with an individual’s daily functions. This trial is part of a long-term project that has studied the biologic basis of and possible treatments for repetitive behavior disorders. The trial will evaluate the effectiveness of two medications, a selective serotonin reuptake inhibitor (SSRI) and an atypical antipsychotic, in treating repetitive behavior disorders in people with mental retardation.
Condition | Intervention | Phase |
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Mental Retardation Stereotyped Behavior Self-Injurious Behavior Compulsive Behavior |
Drug: sertraline |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Efficacy Study |
Official Title: | Stereotypies and Mental Retardation: Neurobiological Basis |
Study Start Date: | September 1992 |
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.
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
Contact: Mark Lewis, PhD | 352-392-3471 | mlewis@psych.med.ufl.edu |
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 |
Study ID Numbers: | R01HD30615 |
Study First Received: | June 22, 2007 |
Last Updated: | June 22, 2007 |
ClinicalTrials.gov Identifier: | NCT00491478 History of Changes |
Health Authority: | United States: Federal Government |
Repetitive behavior disorder Stereotypy Sertraline |
Neurotransmitter Agents Psychotropic Drugs Impulsive Behavior Serotonin Uptake Inhibitors Serotonin Behavioral Symptoms Mental Retardation Compulsive Behavior |
Signs and Symptoms Mental Disorders Mental Disorders Diagnosed in Childhood Neurologic Manifestations Sertraline Neurobehavioral Manifestations Antidepressive Agents Self-Injurious Behavior |
Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Nervous System Diseases Psychotropic Drugs Impulsive Behavior Serotonin Uptake Inhibitors Pharmacologic Actions Behavioral Symptoms Mental Retardation Compulsive Behavior |
Signs and Symptoms Serotonin Agents Mental Disorders Therapeutic Uses Mental Disorders Diagnosed in Childhood Neurologic Manifestations Sertraline Central Nervous System Agents Neurobehavioral Manifestations Antidepressive Agents Self-Injurious Behavior |