Atypical Neuroleptic Drugs in People With Mental Retardation/Developmental Delay

United States Department of Health and Human Services (HHS)

Status and phase

Completed

Phase 3

Conditions

Developmental Delay Disorder

Mental Retardation

Treatments

Drug: olanzapine

Drug: clozapine

Drug: risperidone

Study type

Interventional

Funder types

NIH

Identifiers

NCT00065273

5P01HD026927 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Sex

All

Ages

6 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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