Ignite Creation Date:
2024-05-05 @ 5:17 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00420459
Status:
COMPLETED
Last Update Posted:
2017-04-18
First Post:
2007-01-09
Brief Title:
A Prospective Open-label Study of Aripiprazole in Fragile X Syndrome
Sponsor:
Indiana University School of Medicine
Organization:
Indiana University
Study Overview
Official Title:
Aripiprazole in Fragile X Syndrome
Status:
COMPLETED
Status Verified Date:
2017-03
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 the effectiveness and tolerability of aripiprazole in the treatment of children and adolescents with Fragile X Syndrome
Detailed Description:
This 12-week prospective open-label study design was chosen to gather pilot data for potential future lager scale double-blind placebo-controlled studies in Fragile X Syndrome
We hypothesize that aripiprazole will be effective in decreasing aggression SIB agitation and interfering repetitive behavior commonly observed in individuals with Fragile X Syndrome We also hypothesize that aripiprazole will be well tolerated
We hypothesize that aripiprazole will be effective in decreasing aggression SIB agitation and interfering repetitive behavior commonly observed in individuals with Fragile X Syndrome We also hypothesize that aripiprazole will be well tolerated
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