drugset / Trial / NCT00211757
Divalproex Sodium vs. Placebo in Childhood/Adolescent Autism
Phase 2
Completed
27 enrolled
Montefiore Medical Center
National Institute of Neurological Disorders and Stroke (NINDS) · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
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.
Timeline
- Start
- 2002-09
- Primary completion
- 2008-07
- Completion
- 2008-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Divalproex Sodium | Small molecule | — | — |