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Atypical Neuroleptic Drugs in People With Mental Retardation/Developmental Delay

This study has been completed.
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Identifier:
First received: July 21, 2003
Last updated: June 23, 2005
Last verified: June 2003
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.

Condition Intervention Phase
Mental Retardation Developmental Delay Disorder Drug: risperidone Drug: clozapine Drug: olanzapine Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Severe Aberrant Behavior Among Persons With Mental Retardation. Project III: Behavioral Selectivity of Atypical Neuroleptic Drugs: Effects on Cognitive and Social Behaviors

Resource links provided by NLM:

Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Estimated Enrollment: 50
Study Start Date: July 1998
Estimated Study Completion Date: June 2001
Detailed 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.


Ages Eligible for Study:   6 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00065273

United States, Kansas
University of Kansas
Lawrence, Kansas, United States, 66045
Sponsors and Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Stephen Schroeder, PhD University of Kansas
  More Information

Publications: Identifier: NCT00065273     History of Changes
Other Study ID Numbers: 5P01HD026927 ( U.S. NIH Grant/Contract )
Study First Received: July 21, 2003
Last Updated: June 23, 2005

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Severe aberrant behavior
Laboratory operant tasks
Simple acquisition procedures
Matching to sample task
Lag sequential analysis

Additional relevant MeSH terms:
Intellectual Disability
Developmental Disabilities
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurodevelopmental Disorders
Mental Disorders
Antipsychotic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
GABA Antagonists processed this record on August 18, 2017