Randomized, Placebo-Controlled Trial of D-Cycloserine for the Enhancement of Social Skills Training in Pervasive Developmental Disorders

摘要

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 68 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. In 2011, IRB approval received to allow for enrollment of youth with: (1) stable seizure disorders; and (2) up to two concomitant psychotropic non-glutamatergic drugs. Approval also received for the addition of the Autism Diagnostic Observation Schedule (ADOS) to better characterize ASD pathology. In 2012, the study was expanded to include a second site, led by former Indiana University site PI Craig Erickson, at Cincinnati Children s Hospital Medical Center. This expansion increased the overall study N to 68 youth with ASD and 34 neurotypical peers (originally 52 youth with ASD and 26 neurotypical peers at Indiana University only). Dr. Noha Minshawi was also named lead PI at the Indiana University Site at that time. In addition, IRB approval received to (1) complete TRIAD Social Skills Assessment (TSSA) and Eye Tracking with typically developing peers to provide a normative sample, and (2) record Play Coding behaviors of the typically developing peers from the Social Skills Training sessions.