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.
Atypical neuroleptics have fewer extrapyramidal and behavioral side effects than typical
neuroleptics. Atypical neuroleptics may also improve social and cognitive functioning. This
improvement may be due to reductions in the negative symptoms that are part of the psychosis
and psychiatric syndromes or to the improved side effect profile. This study will examine
the effects of the atypical neuroleptic drugs risperidone, clozapine, and olanzapine on
learning, memory, and social behavior in individuals with MR/DD. A substudy will expand the
study to evaluate ecobehavioral measures. The goal of these studies is to assess the
behavioral selectivity of atypical neuroleptics by measuring cognitive and social
functioning along with targeted aberrant behaviors in individuals under placebo and
different doses of drug.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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