A Randomized, Placebo-Controlled Trial of D-Cycloserine for the Enhancement of Social Skills Training in Pervasive Developmental Disorders
Abstract
The main objective of this application is to determine whether D-cycloserine (DCS) can enhance the efficacy of social skills training (SST) in the treatment of children and young adolescents with autism spectrum disorders (ASDs). We will evaluate the efficacy, tolerability, and last effects of DCS given one hour prior to each of 10 weekly SST sessions for the treatment of social impairment in 52 children and young adolescents (ages 5-11 years) with ASDs during a randomized placebo-controlled trial. The safety and tolerability of DCS and durability of treatment response will also be examined. Institutional IRB and Department of Defense Human Research protections Office approvals have been obtained. Staff have been hired and trained on study procedures. The first ten groups of 6 youth (per group: 4 with ASD and 2 normally developing children) have completed the first SST group and the eleventh and twelfth groups are active in the trial due to complete 10 weeks of treatment in March 2012. We have a set schedule for 4 groups per year. In 2011 received IRB approval of an amendment to allow for enrollment of youth with stable seizure disorders and youth who take up to two concomitant psychotropic non-glutamatergic drugs. In addition we have received IRB approval to add use of the Autism Diagnostic Observation Schedule to better characterize ASD pathology. In 2012 the study was expanded to potentially include a second site, led by former Indiana University site PI Craig Erickson, at Cincinnati Children s Hospital Medical Center. Dr. Noha Minshawi was named lead PI at the Indiana University Site at that time.
Document Details
- Document Type
- Technical Report
- Publication Date
- Mar 01, 2013
- Accession Number
- ADA579410
Entities
People
- Marjorie Mccaskey
Organizations
- Indiana State Department of Health