Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00086645
Status:
COMPLETED
Last Update Posted:
2017-03-10
First Post:
2004-07-07
Brief Title:
Citalopram for Children With Autism and Repetitive Behavior STAART Study 1
Sponsor:
Boston University
Organization:
Boston University
Study Overview
Official Title:
Citalopram Treatment in Children With Autism Spectrum Disorders and High Levels of Repetitive Behavior
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:
This study will determine the efficacy and safety of citalopram compared to placebo in the treatment of children with autism
Detailed Description:
For children with autism spectrum disorders ASD also known as Pervasive Developmental Disorders - PDDs repetitive behaviors are common and frequently interfere with functioning in the home as well as in social and educational settings These behaviors may involve repetitive movements rigid routines repetitive play and even repetitive speech These behaviors may be associated with high levels of anxiety severe tantrums Self-injury can occur when these behaviors and routines are interrupted
Participants will be randomly assigned to receive citalopram or placebo administered as liquid and carefully followed every two weeks At the end of 12 weeks children who have responded to treatment will be given the opportunity to continue in the study with monthly visits for an additional 24 weeks Children who received placebo and did not respond to treatment at 12 weeks will be given the opportunity to receive a carefully monitored 12 week course of citalopram
Participants will be randomly assigned to receive citalopram or placebo administered as liquid and carefully followed every two weeks At the end of 12 weeks children who have responded to treatment will be given the opportunity to continue in the study with monthly visits for an additional 24 weeks Children who received placebo and did not respond to treatment at 12 weeks will be given the opportunity to receive a carefully monitored 12 week course of citalopram
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 |
|---|---|---|---|
| U54MH066398 | NIH | None | httpsreporternihgovquickSearchU54MH066398 |