Ignite Creation Date:
2025-12-24 @ 5:56 PM
Ignite Modification Date:
2025-12-25 @ 3:19 PM
Study NCT ID:
NCT01227668
Status:
COMPLETED
Last Update Posted:
2014-05-02
First Post:
2010-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase IV Long-term Maintenance Study of Aripiprazole in the Treatment of Irritability Associated With Autistic Disorder
Sponsor:
Bristol-Myers Squibb
Organization:
Study Overview
Official Title:
Safety and Efficacy of Aripiprazole in the Long-term Maintenance Treatment of Pediatric Patients With Irritability Associated With Autistic Disorder
Status:
COMPLETED
Status Verified Date:
2014-03
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:
The purpose of this study is to determine whether pediatric participants with irritability associated with autistic disorder who have responded to aripiprazole treatment will experience a relapse significantly later when continuing therapy with aripiprazole than will participants who receive placebo
Detailed Description:
Phase 1: Single blind/ Phase 2: Double blind
Study Oversight
Has Oversight DMC:
False
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?: