Divalproex Sodium ER in Adult Autism
Recruitment status was Recruiting
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Divalproex Sodium ER in Adult Autism|
- the Clinical Global Improvement and Severity scales (CGI-I and CGI-S)
- Overt Aggression Scale-Modified (OAS M)
- Affective Lability Scale (ALS).
- Global Assessment of Functioning Scale (GAF)
- Aggression Questionnaire (AQ)
- the Hamilton Depression (Ham-D) Scale
- Yale Brown Obsessive Compulsion Scale (YBOCS)
- Compulsion sub-scale
- Aberrant Behavior Checklist (ABC)
- Barratt Impulsiveness Scale
- Version11 (BIS-11).
|Study Start Date:||April 2005|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00211796
|Contact: Eric Hollander, MDfirstname.lastname@example.org|
|United States, New York|
|Mount Sinai School of Medicine||Recruiting|
|New York, New York, United States, 10029|
|Contact: Eric Hollander, MD 212-241-3623 email@example.com|
|Principal Investigator:||Eric Hollander, MD||Icahn School of Medicine at Mount Sinai|