Ignite Creation Date:
2024-05-05 @ 4:48 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00318162
Status:
UNKNOWN
Last Update Posted:
2006-05-03
First Post:
2006-04-25
Brief Title:
Trial of Low-Dose Naltrexone for Children With Pervasive Developmental Disorder PDD
Sponsor:
Hadassah Medical Organization
Organization:
Hadassah Medical Organization
Study Overview
Official Title:
Randomized Double-Blind Trial of Low-Dose Naltrexone for Children With PDD
Status:
UNKNOWN
Status Verified Date:
2006-04
Last Known Status:
NOT_YET_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:
This study will examine the effects of low-dose naltrexone LDN on children with autistic spectrum disorders The investigators hope to show a positive effect on social functioning and language
Detailed Description:
Fifty children aged three to six years will be recruited for the study They will be randomly assigned to receive either LDN or placebo for two months after which the treatment groups will be switched over Assessments of functioning will be obtained from a video-taped play session and by parent and teacher questionnaires at baseline after two months and after four months
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