CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 27 enrolled
Drug / intervention
Divalproex sodium +1 moredrug
Likely dose
Not stated in record
Key inclusion· 6
  • ✓Diagnosis of autistic disorder confirmed by DSM-IV criteria, ADI, and ADOS.
  • ✓Age 5 to 17 years.
  • ✓Outpatient status.
  • ✓Moderate-to-severe autism symptoms: CGI-AD score ≥4.
Key exclusion· 9
  • ✕Active or unstable epilepsy.
  • ✕History of hypersensitivity, severe side effects, or prior ineffective divalproex trial (serum levels 50–100 µg/mL for ≥6 weeks).
  • ✕Schizophrenia, schizoaffective disorder, or organic mental disorders.
  • ✕Serious suicidal risk.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00211757
NCT00211757Phase 2Completed
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Divalproex Sodium vs. Placebo in Childhood/Adolescent Autism

Montefiore Medical Center·interventional·Posted Sep 21, 2005·Updated Oct 28, 2024

In Brief

A Phase 2 clinical trial evaluating Divalproex sodium and Placebo for Autism. Completed, enrolled 27 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAutism
CountriesUnited States
CollaboratorsNational Institute of Neurological Disorders and Stroke (NINDS)

Timeline

Phase 2CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 21, 2005
Enrollment StartSep 1, 2002
Primary CompletionJul 1, 2008
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 20.8 years ago

Interventions

Divalproex sodiumdrug

Study drug.

Placebodrug

Placebo comparator.