Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00080145
Status:
COMPLETED
Last Update Posted:
2013-08-16
First Post:
2004-03-24
Brief Title:
RUPP PI PDD Drug and Behavioral Therapy for Children With Pervasive Developmental Disorders
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
Risperidone and Behavioral Therapy in Treatment of Children and Adolescents With Autistic Disorder
Status:
COMPLETED
Status Verified Date:
2013-08
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:
This 24-week study will compare the safety and effectiveness of medication treatment alone risperidone or aripiprazole to medication treatment in combination with a parent management training program
Detailed Description:
PDD can be a profoundly disabling condition across social emotional and academic domains Safe and effective treatments for PDD are needed
Participants are randomly assigned to receive either risperidone plus parent management training or risperidone alone for 24 weeks Participants who show deterioration at Week 4 will be offered an alternative mediation treatment aripiprazole These participants will remain in their original treatment group either med alone or med plus parent management training After 6 months of treatment Week 24 participants who respond to their treatment will be gradually discontinued from their medication treatment to learn if the response can be sustained without continued medication treatment This phase of the study was ended in Nov 2006 Adaptive and behavioral outcomes are assessed during the study
Participants are randomly assigned to receive either risperidone plus parent management training or risperidone alone for 24 weeks Participants who show deterioration at Week 4 will be offered an alternative mediation treatment aripiprazole These participants will remain in their original treatment group either med alone or med plus parent management training After 6 months of treatment Week 24 participants who respond to their treatment will be gradually discontinued from their medication treatment to learn if the response can be sustained without continued medication treatment This phase of the study was ended in Nov 2006 Adaptive and behavioral outcomes are assessed during the study
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 |
|---|---|---|---|
| DDTR BD-DD | US NIH GrantContract | None | httpsreporternihgovquickSearchU10MH066768 |
| U10MH066764 | NIH | None | None |
| U10MH066766 | NIH | None | None |
| U10MH066768 | NIH | None | None |