Mental Retardation Clinical Trial
Official title:
Stereotypies and Mental Retardation: Neurobiological Basis
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.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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