Divalproex Sodium vs. Placebo in Childhood/Adolescent Autism
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|ClinicalTrials.gov Identifier: NCT00211757|
Recruitment Status : Completed
First Posted : September 21, 2005
Results First Posted : December 6, 2018
Last Update Posted : December 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Autism||Drug: Divalproex sodium Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Divalproex Sodium vs. Placebo in Childhood/Adolescent Autism|
|Study Start Date :||September 2002|
|Actual Primary Completion Date :||July 2008|
|Actual Study Completion Date :||July 2008|
Placebo Comparator: Placebo
Subjects in this arm will receive a placebo comparative to the study drug divalproex sodium.
Experimental: Divalproex Sodium
Subjects will receive the study drug, divalproex sodium.
Drug: Divalproex sodium
- 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 outcome measure) and a general version CGI-I-autism focused on all symptoms including core symptom domains. The CGI-I irritability took into consideration the scores from the ABC-Irritability subscale, the OAS-M aggression and irritability subscales and information from open-ended questioning related to the degree of interference, nature, and range of behavioral problems at school and at home
- 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 Irritability subscale, 0-48 for Lethargy subscale, 0-21 for stereotypy scale, 0-48 for hyperactivity sub-scale, and 0-12 for inappropriate speech sub-scale) to obtain a total score.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00211757
|United States, New York|
|Mount Sinai School of Medicine|
|New York, New York, United States, 10029|
|Principal Investigator:||Eric Hollander||Icahn School of Medicine at Mount Sinai|