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Trial record 34 of 72 for:    "Asperger syndrome"

D-Cycloserine and Social Skills Training in Autism Spectrum Disorders

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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited from academic autism treatment centers, local schools, and community organizations.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
One subject with ASD was excluded from analyses due to early dropout prior to taking the study drug.

Reporting Groups
  Description
D-cycloserine Subjects who received d-cycloserine
Placebo Subjects who received placebo

Participant Flow:   Overall Study
    D-cycloserine   Placebo
STARTED   34   33 
COMPLETED   34   33 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
D-cycloserine

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

Placebo

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 Total of all reporting groups

Baseline Measures
   D-cycloserine   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 34   33   67 
Age 
[Units: Participants]
     
<=18 years   34   33   67 
Between 18 and 65 years   0   0   0 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 8.49  (1.88)   8.34  (1.70)   8.41  (1.78) 
Gender 
[Units: Participants]
     
Female   6   6   12 
Male   28   27   55 
Region of Enrollment 
[Units: Participants]
     
United States   34   33   67 


  Outcome Measures

1.  Primary:   Social Responsiveness Scale (SRS) Change   [ Time Frame: Completed at Baseline and Week 11 ]

2.  Primary:   Social Responsiveness Scale (SRS) at Follow-Up   [ Time Frame: Completed at Week 22 ]

3.  Secondary:   Clinical Global Impressions Improvement Scale Responder Analysis   [ Time Frame: Week 11 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: nminshaw@iupui.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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