Atypical Neuroleptic Drugs in People With Mental Retardation/Developmental Delay

Completed · Phase 3

Conditions studied: Mental Retardation, Developmental Delay Disorder

In brief

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.

Key facts

Study ID

NCT00065273

Run by

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

People needed

50

Starts

1998-07-01

Expected to finish

2001-06-01

Last updated by the study team

2005-06-24

Who can join

Age: 6 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Kansas — Lawrence, Kansas, United States

Full record on ClinicalTrials.gov

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