ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 34 of 73 for:    "Asperger syndrome"

D-Cycloserine and Social Skills Training in Autism Spectrum Disorders

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: NCT01086475
Recruitment Status : Completed
First Posted : March 15, 2010
Results First Posted : April 14, 2016
Last Update Posted : April 14, 2016
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Indiana University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions Autistic Disorder
Asperger's Disorder
Pervasive Developmental Disorder NOS
Interventions Drug: D-cycloserine
Drug: Placebo
Enrollment 68
Recruitment Details Participants were recruited from academic autism treatment centers, local schools, and community organizations.
Pre-assignment Details One subject with ASD was excluded from analyses due to early dropout prior to taking the study drug.
Arm/Group Title D-cycloserine Placebo
Hide Arm/Group Description Subjects who received d-cycloserine Subjects who received placebo
Period Title: Overall Study
Started 34 33
Completed 34 33
Not Completed 0 0
Arm/Group Title D-cycloserine Placebo Total
Hide Arm/Group Description

Subjects randomized to D-cycloserine will be administered 50 mg 30 minutes prior to each of ten Social Skills Training Sessions

D-cycloserine: 50 mg dose administered 30 minutes prior to each of the ten Social Skill Training Sessions

Subjects randomized to placebo arm will receive placebo pill 30 minutes prior to each of ten Social Skills Training Sessions

Placebo: Placebo pill administered 30 minutes prior to each of the ten Social Skill Training Sessions

Total of all reporting groups
Overall Number of Baseline Participants 34 33 67
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 33 participants 67 participants
<=18 years
34
 100.0%
33
 100.0%
67
 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%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 34 participants 33 participants 67 participants
8.49  (1.88) 8.34  (1.70) 8.41  (1.78)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 33 participants 67 participants
Female
6
  17.6%
6
  18.2%
12
  17.9%
Male
28
  82.4%
27
  81.8%
55
  82.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 34 participants 33 participants 67 participants
34 33 67
1.Primary Outcome
Title Social Responsiveness Scale (SRS) Change
Hide Description

The 65-item SRS is a standardized measure of the core symptoms of autism. Each item is scored on a 4-point Likert scale. The score of each individual item is summed to create a total raw score. A total scores results are as follows:

0-62: Within normal limits 63-79: Mild range of impairment 80-108: Moderate range of impairment 109-149: Severe range of impairment

Time Frame Completed at Baseline and Week 11
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Each group included up to four children with ASD and two typically-developing peer models (TPs) in the same age group.
Arm/Group Title D-cycloserine Placebo
Hide Arm/Group Description:
Subjects who received d-cycloserine
Subjects who received placebo
Overall Number of Participants Analyzed 34 33
Mean (Standard Deviation)
Unit of Measure: units on a scale
-13.39  (16.81) -17.00  (21.33)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection D-cycloserine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.45
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Primary Outcome
Title Social Responsiveness Scale (SRS) at Follow-Up
Hide Description

The 65-item SRS is a standardized measure of the core symptoms of autism. Each item is scored on a 4-point Likert scale. The score of each individual item is summed to create a total raw score. A total scores results are as follows:

0-62: Within normal limits 63-79: Mild range of impairment 80-108: Moderate range of impairment 109-149: Severe range of impairment

Time Frame Completed at Week 22
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Each group included up to four children with ASD and two typically-developing peer models (TPs) in the same age group.
Arm/Group Title D-cycloserine Placebo
Hide Arm/Group Description:
Subjects who received d-cycloserine
Subjects who received placebo
Overall Number of Participants Analyzed 34 33
Mean (Standard Deviation)
Unit of Measure: units on a scale
83.5  (2.3) 89.2  (2.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection D-cycloserine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.048
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
3.Secondary Outcome
Title Clinical Global Impressions Improvement Scale Responder Analysis
Hide Description The CGI Global Improvement (CGI-I) is a clinician-rate scale designed to take into account all factors to arrive at an assessment of severity and response to treatment, including parent report, parent-rated measures, teacher-rated measures, and clinician-rated measures. The CGI-I is rated from 1 to 7 (1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse) at a single time-point. The CGI-I was completed at each visit, but only at week 11 were those subjects classified as “much” or “very much improved” defined as responders and all other classifications will be regarded as non-responders.
Time Frame Week 11
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Each social skills group included up to four children with ASD and two typically-developing peer models (TPs) in the same age group.
Arm/Group Title D-cycloserine Placebo
Hide Arm/Group Description:
Subjects who received d-cycloserine
Subjects who received placebo
Overall Number of Participants Analyzed 34 33
Measure Type: Number
Unit of Measure: percentage of participants
32.3 33.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection D-cycloserine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.927
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Time Frame Data collected at each visit
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title D-cycloserine Placebo
Hide Arm/Group Description Subjects who received d-cycloserine Subjects who received placebo
All-Cause Mortality
D-cycloserine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
D-cycloserine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/34 (0.00%)      1/33 (3.03%)    
Psychiatric disorders     
Suicidal comment * [1]  0/34 (0.00%)  0 1/33 (3.03%)  1
*
Indicates events were collected by non-systematic assessment
[1]
One instance of making a suicidal comment at school when angry.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
D-cycloserine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   32/34 (94.12%)      28/33 (84.85%)    
General disorders     
Headache *  9/34 (26.47%)  9 7/33 (21.21%)  7
Nasal congestion or Cold *  6/34 (17.65%)  6 8/33 (24.24%)  8
Cough *  7/34 (20.59%)  7 7/33 (21.21%)  7
Vomiting *  6/34 (17.65%)  6 2/33 (6.06%)  2
Increased Motor Activity *  1/34 (2.94%)  1 5/33 (15.15%)  5
Interrupted Sleep/Other sleep problems *  3/34 (8.82%)  3 5/33 (15.15%)  5
Restlessness/Agitation *  4/34 (11.76%)  4 3/33 (9.09%)  3
Sedation/Drowsiness *  2/34 (5.88%)  2 6/33 (18.18%)  6
Psychiatric disorders     
Aggression *  2/34 (5.88%)  2 5/33 (15.15%)  5
Irritability *  16/34 (47.06%)  16 15/33 (45.45%)  15
Sadness *  5/34 (14.71%)  5 3/33 (9.09%)  3
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Minshawi
Organization: Christian Sarkine Autism Treatment Center
Phone: 317-944-8162
Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT01086475     History of Changes
Other Study ID Numbers: 0906-09
First Submitted: March 10, 2010
First Posted: March 15, 2010
Results First Submitted: August 28, 2015
Results First Posted: April 14, 2016
Last Update Posted: April 14, 2016