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Divalproex Sodium vs. Placebo in Childhood/Adolescent Autism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00211757
Recruitment Status : Completed
First Posted : September 21, 2005
Results First Posted : December 6, 2018
Last Update Posted : December 6, 2018
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Eric Hollander, Montefiore Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Autism
Interventions Drug: Divalproex sodium
Drug: Placebo
Enrollment 27
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Divalproex Sodium
Hide Arm/Group Description

Subjects in this arm will receive a placebo comparative to the study drug divalproex sodium.

Placebo: Placebo comparator.

Subjects will receive the study drug, divalproex sodium.

Divalproex sodium: Study drug.

Period Title: Overall Study
Started 11 16
Completed 10 14
Not Completed 1 2
Reason Not Completed
Withdrawal by Subject             1             1
Lack of Efficacy             0             1
Arm/Group Title Placebo Divalporex Sodium Total
Hide Arm/Group Description

Subjects in this arm will receive a placebo comparative to the study drug divalproex sodium.

Placebo: Placebo comparator.

Subjects will receive the study drug, divalproex sodium.

Divalproex sodium: Study drug.

Total of all reporting groups
Overall Number of Baseline Participants 11 16 27
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 16 participants 27 participants
<=18 years
11
 100.0%
16
 100.0%
27
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 16 participants 27 participants
Female
1
   9.1%
3
  18.8%
4
  14.8%
Male
10
  90.9%
13
  81.3%
23
  85.2%
Diagnosis   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 16 participants 27 participants
Autistic Disorder
9
  81.8%
14
  87.5%
23
  85.2%
Asperger's Syndrome
2
  18.2%
2
  12.5%
4
  14.8%
[1]
Measure Description: Subjects were either diagnosed with Autistic Disorder or Asperger's syndrome
1.Primary Outcome
Title Number of Participants Reporting Improvement on the Clinical Global Impression
Hide Description 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
Time Frame Baseline to end of study (week 15)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Divalproex Sodium
Hide Arm/Group Description:

Subjects in this arm will receive a placebo comparative to the study drug divalproex sodium.

Placebo: Placebo comparator.

Subjects will receive the study drug, divalproex sodium.

Divalproex sodium: Study drug.

Overall Number of Participants Analyzed 11 16
Measure Type: Count of Participants
Unit of Measure: Participants
1
   9.1%
10
  62.5%
2.Primary Outcome
Title Change in Aberrant Behaviors as Measured by the Aberrant Behavior Checklist Scores
Hide Description 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.
Time Frame Baseline and End of Study (week 15)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Divalproex Sodium
Hide Arm/Group Description:

Subjects in this arm will receive a placebo comparative to the study drug divalporex sodium.

Placebo: Placebo comparator.

Subjects will receive the study drug, divalproex sodium.

divalproex sodium: Study drug.

Overall Number of Participants Analyzed 11 16
Mean (Standard Deviation)
Unit of Measure: units on a scale
baseline 22  (7.81) 20.3  (7.36)
Week 15 14.5  (6.67) 17.7  (7.94)
Time Frame 6 weeks on treatment
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Divalproex Sodium
Hide Arm/Group Description

Subjects in this arm will receive a placebo comparative to the study drug divalproex sodium.

Placebo: Placebo comparator.

Subjects will receive the study drug, divalproex sodium.

Divalproex sodium: Study drug.

All-Cause Mortality
Placebo Divalproex Sodium
Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)   0/16 (0.00%) 
Hide Serious Adverse Events
Placebo Divalproex Sodium
Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)   0/16 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Placebo Divalproex Sodium
Affected / at Risk (%) Affected / at Risk (%)
Total   8/11 (72.73%)   7/16 (43.75%) 
General disorders     
Insomnia *  2/11 (18.18%)  2/16 (12.50%) 
headache *  0/11 (0.00%)  1/16 (6.25%) 
polyuria *  0/11 (0.00%)  2/16 (12.50%) 
agitation *  1/11 (9.09%)  2/16 (12.50%) 
Hypersomnolence   3/11 (27.27%)  0/16 (0.00%) 
Immune system disorders     
Infection *  3/11 (27.27%)  2/16 (12.50%) 
Metabolism and nutrition disorders     
Weight gian   1/11 (9.09%)  1/16 (6.25%) 
Skin and subcutaneous tissue disorders     
Rash   0/11 (0.00%)  2/16 (12.50%) 
*
Indicates events were collected by non-systematic assessment
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Eric Hollander
Organization: Montefiore Medical Center
Phone: 718-920-4287
EMail: eholland@montefiore.org
Layout table for additonal information
Responsible Party: Eric Hollander, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT00211757    
Other Study ID Numbers: 01-0294
1R21NS043979 ( U.S. NIH Grant/Contract )
First Submitted: September 13, 2005
First Posted: September 21, 2005
Results First Submitted: May 29, 2018
Results First Posted: December 6, 2018
Last Update Posted: December 6, 2018