Trial · NCT00211757

Divalproex Sodium vs. Placebo in Childhood/Adolescent Autism

NCT00211757, Phase 2, Completed, Montefiore Medical Center; results first posted 2018-12-06

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Divalproex Sodium vs. Placebo in Childhood/Adolescent Autism. Trials, record NCT00211757. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00211757

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Divalproex Sodium vs. Placebo in Childhood/Adolescent Autism
NCT number: NCT00211757
Status: Completed
Phases: Phase 2
Enrollment: 27 participants, actual
Lead sponsor: Montefiore Medical Center
Conditions: Autism
Interventions: Divalproex sodium, Placebo
First posted: 2005-09-21
Last updated: 2024-10-28
Results first posted: 2018-12-06

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants Reporting Improvement on the Clinical Global Impression	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
Primary	Change in Aberrant Behaviors as Measured by the Aberrant Behavior Checklist Scores	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 an overall score with a an overall scoring range of 0-174. Higher scores were indicative of worsening symptoms.

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants Reporting Improvement on the Clinical Global Impression	Baseline to end of study (week 15)		Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Change in Aberrant Behaviors as Measured by the Aberrant Behavior Checklist Scores	Baseline and End of Study (week 15)		score on a scale	MEAN

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Number of Participants Reporting Improvement on the Clinical Global Impression	Placebo		1		Participants
Number of Participants Reporting Improvement on the Clinical Global Impression	Divalproex Sodium		10		Participants
Change in Aberrant Behaviors as Measured by the Aberrant Behavior Checklist Scores	Placebo	baseline	22	Standard Deviation 7.81	score on a scale
Change in Aberrant Behaviors as Measured by the Aberrant Behavior Checklist Scores	Divalproex Sodium	baseline	20.3	Standard Deviation 7.36	score on a scale
Change in Aberrant Behaviors as Measured by the Aberrant Behavior Checklist Scores	Placebo	Week 15	14.5	Standard Deviation 6.67	score on a scale
Change in Aberrant Behaviors as Measured by the Aberrant Behavior Checklist Scores	Divalproex Sodium	Week 15	17.7	Standard Deviation 7.94	score on a scale

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	11
Overall Study	STARTED	Divalproex Sodium	16
Overall Study	COMPLETED	Placebo	10
Overall Study	COMPLETED	Divalproex Sodium	14
Overall Study	NOT COMPLETED	Placebo	1
Overall Study	NOT COMPLETED	Divalproex Sodium	2

Source ClinicalTrials.gov

Adverse events16

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Insomnia	General disorders	Placebo	2	11
other	Insomnia	General disorders	Divalproex Sodium	2	16
other	Rash	Skin and subcutaneous tissue disorders	Placebo	0	11
other	Rash	Skin and subcutaneous tissue disorders	Divalproex Sodium	2	16
other	Weight gian	Metabolism and nutrition disorders	Placebo	1	11
other	Weight gian	Metabolism and nutrition disorders	Divalproex Sodium	1	16
other	headache	General disorders	Placebo	0	11
other	headache	General disorders	Divalproex Sodium	1	16
other	polyuria	General disorders	Placebo	0	11
other	polyuria	General disorders	Divalproex Sodium	2	16

1 to 10 of 16Source ClinicalTrials.gov

See all 16 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	11
Total, all-cause mortality	Divalproex Sodium	0	16
Total, other adverse events	Placebo	8	11
Total, other adverse events	Divalproex Sodium	7	16
Total, serious adverse events	Placebo	0	11
Total, serious adverse events	Divalproex Sodium	0	16

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
37811711	DERIVED

Source PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R21NS043979	Divalproex Sodium/Placebo In Child/Adolesent Autism	HOLLANDER, ERIC	MOUNT SINAI SCHOOL OF MEDICINE OF NYU	NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE	2001 to 2003

Source NIH RePORTER

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Divalproex Sodium vs Placebo: Number of Participants Reporting Improvement on the Clinical Global Impression	Trial comparisons
Divalproex Sodium vs Placebo: deaths from any cause	Trial comparisons
Divalproex Sodium vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00211757

GET https://conductscience.org/api/trials/v1/NCT00211757/registered

API reference For AI assistants