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Atypical Neuroleptic Drugs in People With Mental Retardation/Developmental Delay

This study has been completed.
Sponsor:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00065273
First received: July 21, 2003
Last updated: June 23, 2005
Last verified: June 2003
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
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

Ages Eligible for Study:   6 Years to 60 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00065273

Locations
United States, Kansas
University of Kansas
Lawrence, Kansas, United States, 66045
Sponsors and Collaborators
Investigators
Principal Investigator: Stephen Schroeder, PhD University of Kansas
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00065273     History of Changes
Other Study ID Numbers: 5P01HD26927, 5 PO1 HD 26927
Study First Received: July 21, 2003
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

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:
Developmental Disabilities
Intellectual Disability
Mental Disorders
Mental Disorders Diagnosed in Childhood
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Antipsychotic Agents
Clozapine
Risperidone
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Antagonists
GABA Agents
GABA Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Antagonists
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 25, 2014