NCT00211757

Divalproex Sodium vs. Placebo in Childhood/Adolescent Autism

Completed Phase 2 Results posted Last updated 16 October 2024

What this trial tests

Phase 2 trial testing Divalproex sodium in Autism in 27 participants. Completed in 1 July 2008.

Timeline

1 September 2002

Primary endpoint
1 July 2008

1 July 2008

Quick facts

Lead sponsor	Montefiore Medical Center
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	27
Start date	1 September 2002
Primary completion	1 July 2008
Estimated completion	1 July 2008
Sites	1 location across United States

Drugs / interventions tested

• Divalproex sodium — full drug profile →
• Placebo

Conditions studied

• Autism — all drugs for Autism →

Sponsor

Montefiore Medical Center

Who can join

Adults 5 to 17, any sex, with Autism. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Number of Participants Reporting Improvement on the Clinical Global Impression
  Time frame: Baseline to end of study (week 15)
  The CGI-I is a 7-point improvement scale. Ratings of 1 or 2 (responders) indicate a substantial reduction in symptoms. A rating of 3 (minimally improved) on the CGI is defined as a slight symptomatic improvement that is not deemed clinically significant; patients with such an improvement were not considered responders. Two versions of this test were used, one focused on irritability (primary outco
• Change in Aberrant Behaviors as Measured by the Aberrant Behavior Checklist Scores
  Time frame: Baseline and End of Study (week 15)
  The Aberrant Behavior Checklist is designed to objectively identify five behavior sub scales through observation by the primary caregiver: irritability, lethargy, stereotypy, hyperactivity, and inappropriate speech. The ABC was filled out by parents on a scale from 0-3 for each category. (0 being not a problem, 3 being severe problem). Scores from all sub scales were added (scoring 0-45 for Irrita

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Divalproex sodium vs placebo for the treatment of irritability in children and adolescents with autism spectrum disorders.
   Hollander E, Chaplin W, Soorya L, Wasserman S, et al · · 2010 · cited 117× · PMID 20010551 · DOI 10.1038/npp.2009.202
2. Unveiling the role of histone deacetylases in neurological diseases: focus on epilepsy.
   Cao DF, Zhou XY, Guo Q, Xiang MY, et al · · 2024 · cited 37× · PMID 39563472 · DOI 10.1186/s40364-024-00687-6
3. The BOLD signal and neurovascular coupling in autism.
   Reynell C, Harris JJ. · · 2013 · cited 30× · PMID 23917518 · DOI 10.1016/j.dcn.2013.07.003
4. Pharmacological intervention for irritability, aggression, and self-injury in autism spectrum disorder (ASD).
   Iffland M, Livingstone N, Jorgensen M, Hazell P, et al · · 2023 · cited 21× · PMID 37811711 · DOI 10.1002/14651858.cd011769.pub2