Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00065273
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2003-07-21
Brief Title:
Atypical Neuroleptic Drugs in People With Mental RetardationDevelopmental Delay
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Study Overview
Official Title:
Severe Aberrant Behavior Among Persons With Mental Retardation Project III Behavioral Selectivity of Atypical Neuroleptic Drugs Effects on Cognitive and Social Behaviors
Status:
COMPLETED
Status Verified Date:
2003-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Psychiatric drugs are often used to treat behavioral symptoms of mental retardationdevelopmental delay MRDD 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 MRDD
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 MRDD 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5P01HD026927 | NIH | None | httpsreporternihgovquickSearch5P01HD026927 |