Ignite Creation Date:
2024-05-05 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00491478
Status:
UNKNOWN
Last Update Posted:
2007-06-26
First Post:
2007-06-22
Brief Title:
Repetitive Behavior Disorders in People With Severe Mental Retardation
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:
Stereotypies and Mental Retardation Neurobiological Basis
Status:
UNKNOWN
Status Verified Date:
2003-05
Last Known Status:
RECRUITING
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:
Repetitive behavior disorders are prevalent among people with severe mental retardation These disorders can interfere significantly with an individuals daily functions This trial is part of a long-term project that has studied the biologic basis of and possible treatments for repetitive behavior disorders The trial will evaluate the effectiveness of two medications a selective serotonin reuptake inhibitor SSRI and an atypical antipsychotic in treating repetitive behavior disorders in people with mental retardation
Detailed Description:
Abnormal repetitive behaviors odd or inappropriate movements self-injury and compulsions are among the aberrant behaviors exhibited by individuals with mental retardation However little is known about their pathobiology and treatments are largely unconfirmed by controlled trials For example few controlled studies have examined the efficacy of pharmacological treatment of abnormal repetitive behavior in individuals with mental retardation
This trial is part of a larger project designed to elucidate the neurobiological bases of repetitive behavior disorders and to develop rational safe and effective pharmacological treatments Thus far the project has established a pathophysiological basis for stereotyped behavior disorder demonstrated the role of central dopamine deficiency in stereotyped behavior disorder and provided evidence of the efficacy of both 5-HT uptake inhibitors and atypical antipsychotics in treating stereotyped behaviors
There is currently little information to guide the clinician in deciding which drug class may be more effective for which abnormal repetitive behaviors and for which individuals Moreover little work has attempted to identify variables that may predict differential treatment response This trial will assess the relative efficacy of an SSRI and an atypical antipsychotic across multiple categories of abnormal repetitive behaviors
This trial is part of a larger project designed to elucidate the neurobiological bases of repetitive behavior disorders and to develop rational safe and effective pharmacological treatments Thus far the project has established a pathophysiological basis for stereotyped behavior disorder demonstrated the role of central dopamine deficiency in stereotyped behavior disorder and provided evidence of the efficacy of both 5-HT uptake inhibitors and atypical antipsychotics in treating stereotyped behaviors
There is currently little information to guide the clinician in deciding which drug class may be more effective for which abnormal repetitive behaviors and for which individuals Moreover little work has attempted to identify variables that may predict differential treatment response This trial will assess the relative efficacy of an SSRI and an atypical antipsychotic across multiple categories of abnormal repetitive behaviors
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