Atypical Neuroleptic Drugs in People With Mental Retardation/Developmental Delay

• Status: Completed
• Trial end date: 2001-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Treatments: Antipsychotic Agents; Clozapine; Olanzapine; Risperidone

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