Atypical Neuroleptic Drugs in People With Mental Retardation/Developmental Delay
NCT ID: NCT00065273
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
50 participants
INTERVENTIONAL
1998-07-31
2001-06-30
Brief Summary
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Detailed Description
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Fifty participants will be randomized to receive risperidone, clozapine, olanzapine, or placebo. Twenty-five of the participants will be drawn from a group receiving typical neuroleptics at the onset of the study. The efficacy of atypical neuroleptics in reducing destructive, aggressive, and stereotypic behaviors in persons with mental retardation will be assessed.
Learning and memory will be measured using laboratory operant tasks. Social and environmental interactions, as well as primary target behaviors, will be directly measured by trained observers. The frequency of specific aberrant behaviors will be determined, along with the conditional probabilities that certain environmental events proceed and follow these behaviors. In the substudy, categories of aberrant behavior will be used to provide information relevant to environmental variables maintaining aberrant behavior; this categorization will improve the determinations of pharmacologic efficacy and will provide a better understanding of the relationship between atypical neuroleptics and environmentally maintained aberrant behavior.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Interventions
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risperidone
clozapine
olanzapine
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* 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
6 Years
60 Years
ALL
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Principal Investigators
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Stephen Schroeder, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Kansas
Locations
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University of Kansas
Lawrence, Kansas, United States
Countries
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References
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