Atypical Neuroleptic Drugs in People With Mental Retardation/Developmental Delay

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00065273
Recruitment Status : Completed
First Posted : July 22, 2003
Last Update Posted : June 24, 2005
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

July 21, 2003
July 22, 2003
June 24, 2005
July 1998
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Atypical Neuroleptic Drugs in People With Mental Retardation/Developmental Delay
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.

Phase 3
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
  • Mental Retardation
  • Developmental Delay Disorder
  • Drug: risperidone
  • Drug: clozapine
  • Drug: olanzapine
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
June 2001
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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
Sexes Eligible for Study: All
6 Years to 60 Years   (Child, Adult)
Contact information is only displayed when the study is recruiting subjects
United States
5P01HD026927( U.S. NIH Grant/Contract )
5P01HD026927 ( U.S. NIH Grant/Contract )
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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Principal Investigator: Stephen Schroeder, PhD University of Kansas
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
June 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP