Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00065884
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2003-08-01
Brief Title:
Valproate Response in Aggressive Autistic Adolescents
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Study Overview
Official Title:
Valproate Response in Aggressive Autistic Adolescents
Status:
UNKNOWN
Status Verified Date:
2003-06
Last Known Status:
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 effect of valproate a medication used to treat seizures and bipolar disorder on aggressive behavior in children and adolescents with autism
Detailed Description:
Autism is a complex biological disorder that generally lasts throughout a persons life It starts before age three and causes delays or problems with many different ways in which a person develops or grows Some people with autism become very aggressive and can hurt others or themselves This study will test the hypothesis that aggressive autistic adolescents will show a significantly greater response to valproate maintained at blood levels of 75-100 mcgml than to placebo The study will also assess the safety of valproate in autistic adolescents This represents the first double-blind study of valproate in mentally retardeddevelopmentally delayed populations
Participants in this study will undergo DSM-IV evaluation the Autism Diagnostic Interview-Revised and Autism Diagnostic Observation Schedule and baseline blood tests After baseline screening all participants will be given a placebo for 1 week Participants will then be randomized to receive either valproate or placebo for 8 weeks Dosage adjustment according to blood levels drawn at the end of weeks 2 and 4 will be arranged with parents by a child psychiatrist without breaking the blind The Aberrant Behavior Check-list-Community ABC-C irritability subscale will be the primary measure the Overt Aggression Scale OAS ABC-C hyperactivity subscale Clinical Global Impressions CGI problem severity Self-Injurious Behavior Questionnaire SIB-Q and a valproate side effects checklist will be secondary measures
Participants in this study will undergo DSM-IV evaluation the Autism Diagnostic Interview-Revised and Autism Diagnostic Observation Schedule and baseline blood tests After baseline screening all participants will be given a placebo for 1 week Participants will then be randomized to receive either valproate or placebo for 8 weeks Dosage adjustment according to blood levels drawn at the end of weeks 2 and 4 will be arranged with parents by a child psychiatrist without breaking the blind The Aberrant Behavior Check-list-Community ABC-C irritability subscale will be the primary measure the Overt Aggression Scale OAS ABC-C hyperactivity subscale Clinical Global Impressions CGI problem severity Self-Injurious Behavior Questionnaire SIB-Q and a valproate side effects checklist will be secondary measures
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 |
|---|---|---|---|
| K08MH001516 | NIH | None | httpsreporternihgovquickSearchK08MH001516 |