Atypical Neuroleptic Drugs in People With Mental Retardation/Developmental Delay
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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 |
| Estimated Enrollment: | 50 |
| Study Start Date: | July 1998 |
| Estimated Study Completion Date: | June 2001 |
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 |
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 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 Mental Retardation Mental Disorders Diagnosed in Childhood Mental Disorders Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases Signs and Symptoms Clozapine Risperidone Antipsychotic Agents Olanzapine Serotonin Antagonists Serotonin Agents Neurotransmitter Agents |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Tranquilizing Agents Central Nervous System Depressants Central Nervous System Agents Therapeutic Uses Psychotropic Drugs GABA Antagonists GABA Agents Dopamine Antagonists Dopamine Agents Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Antiemetics |
ClinicalTrials.gov processed this record on May 16, 2013