Mental Retardation Clinical Trial
Official title:
Severe Aberrant Behavior Among Persons With Mental Retardation. Project III: Behavioral Selectivity of Atypical Neuroleptic Drugs: Effects on Cognitive and Social Behaviors
Psychiatric drugs are often used to treat behavioral symptoms of mental retardation/developmental delay (MR/DD). These drugs can cause serious side effects. Newer drugs may have decreased side effects. This study will compare new and old drugs used to treat behavioral symptoms in people with MR/DD.
Status | Completed |
Enrollment | 50 |
Est. completion date | June 2001 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 6 Years to 60 Years |
Eligibility |
Inclusion Criteria - Primary diagnosis of mental retardation (IQ < 70) - Scheduled for medication reductions from psychotropic drugs and subsequent placement on risperidone - Severe self-injury, aggression, property destruction, or stereotypic behavior for 6 months prior to study entry - No seizures, or seizures under control of medication for previous 2 years Additional Inclusion Criteria for Substudy - Participants in the primary study who are available for 2 hour weekly or bi-weekly clinic visits and are able to have observers in their home, school, and/or work environment Exclusion Criteria - Degenerative disease that may affect motor or cognitive functioning - Progressive disease of an organ system - Advanced age that may produce deteriorating cognitive or motor functioning - Multiple sensory or motor disabilities that will interfere with seeing the stimuli and responding to the computer |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Kansas | Lawrence | Kansas |
Lead Sponsor | Collaborator |
---|---|
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
United States,
Hammock R, Levine WR, Schroeder SR. Brief report: effects of clozapine on self-injurious behavior of two risperidone nonresponders with mental retardation. J Autism Dev Disord. 2001 Feb;31(1):109-13. — View Citation
Hellings JA, Zarcone JR, Crandall K, Wallace D, Schroeder SR. Weight gain in a controlled study of risperidone in children, adolescents and adults with mental retardation and autism. J Child Adolesc Psychopharmacol. 2001 Fall;11(3):229-38. — View Citation
McAdam DB, Zarcone JR, Hellings J, Napolitano DA, Schroeder SR. Effects of risperidone on aberrant behavior in persons with developmental disabilities: II. Social validity measures. Am J Ment Retard. 2002 Jul;107(4):261-9. — View Citation
Valdovinos MG, Napolitano DA, Zarcone JR, Hellings JA, Williams DC, Schroeder SR. Multimodal evaluation of risperidone for destructive behavior: functional analysis, direct observations, rating scales, and psychiatric impressions. Exp Clin Psychopharmacol. 2002 Aug;10(3):268-75. — View Citation
Zarcone JR, Hellings JA, Crandall K, Reese RM, Marquis J, Fleming K, Shores R, Williams D, Schroeder SR. Effects of risperidone on aberrant behavior of persons with developmental disabilities: I. A double-blind crossover study using multiple measures. Am J Ment Retard. 2001 Nov;106(6):525-38. — View Citation
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