Divalproex Sodium vs. Placebo in Childhood/Adolescent Autism
The study is designed to assess the efficacy of treatment with divalproex sodium (DS) vs. placebo in childhood/adolescent autism fulfilling DSM-IV and Autism Diagnostic Interview (ADI) criteria. Currently, there are no FDA-approved treatments for this disorder, although behavioral and educational therapies and a variety of medications may play a role in the management of some autistic symptoms.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Divalproex Sodium vs. Placebo in Childhood/Adolescent Autism|
- Clinical Global Impression-Improvement [ Time Frame: Study End ] [ Designated as safety issue: No ]
- Change in Aberrant Behavior Checklist Scores [ Time Frame: Baseline and Study End ] [ Designated as safety issue: No ]
|Study Start Date:||September 2002|
|Study Completion Date:||July 2008|
|Primary Completion Date:||July 2008 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo
Subjects in this arm will receive a placebo comparative to the study drug divalporex sodium.
Experimental: Divalporex Sodium
Subjects will receive the study drug, divalproex sodium.
Drug: Divalproex sodium
This study compares divalproex sodium and placebo in the treatment of autistic disorder. Twenty six child or adolescent outpatients, with age ranges from 5-17, will be randomized into a 12-week double-blind, placebo-controlled parallel treatment study. During the 12 weeks, patients will be monitored by the treating psychiatrist and assessed by an independent evaluator (IE). The IE will perform study assessments while remaining blind to medication regimens (including possible tapering) as well as any side effects. Study assessments will be administered at designated time points
|United States, New York|
|Mount Sinai School of Medicine|
|New York, New York, United States, 10029|
|Principal Investigator:||Eric Hollander||Mount Sinai School of Medicine|