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Atypical Neuroleptic Drugs in People With Mental Retardation/Developmental Delay

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00065273
First Posted: July 22, 2003
Last Update Posted: December 9, 2005
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.
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  Purpose
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00065273


Locations
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)
Investigators
Principal Investigator: Stephen Schroeder, PhD University of Kansas
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00065273     History of Changes
Other Study ID Numbers: 5P01HD026927 ( U.S. NIH Grant/Contract )
First Submitted: July 21, 2003
First Posted: July 22, 2003
Last Update Posted: December 9, 2005
Last Verified: June 2003

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Severe aberrant behavior
Risperidone
Clozapine
Haloperidol
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
Risperidone
Clozapine
Olanzapine
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
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
GABA Antagonists