Autism Clinical Trial - Divalproex Sodium ER in Adult Autism

Status Completed

Clinical Trial Summary

12-week open label treatment trial of divalproex sodium extended release (Depakote ER) in 10 patients with a diagnosis of autism. Our objective is to determine how well these patients can tolerate the prescribed doses and what added benefits can be attributed to divalproex sodium ER.

Clinical Trial Description

Based on positive research with divalproex in children/adolescents with autism, we would like to extend this research to autistic adults with high levels of aggression, irritability, affective instability, or agitation. We aim to have 10 adult autistic patients enrolled in our study of the treatment of aggression/irritability with divalproex sodium ER. This will be an open treatment for adult patients to determine if the tolerability of divalproex sodium is better with the extended release. We propose this open label design because previous double-blinded studies of divalproex sodium were only done in children, not adults. These results will serve as pilot data for a future blinded study for autistic adults with the extended release formulation. This naturalistic design will allow for prior stable (3 months) use of concomitant medications. Our objective is to determine how well these patients can tolerate the prescribed doses and what added benefits can be attributed to divalproex sodium ER. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00211796
Study type	Interventional
Source	Montefiore Medical Center
Contact
Status	Completed
Phase	Phase 4
Start date	April 2005
Completion date	April 2007

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