A Randomized, Placebo-Controlled Trial of D-cycloserine for the Enhancement of Social Skills Training in Pervasive Developmental Disorders
Annual rept. 1 Mar 2011-29 Feb 2012
INDIANA UNIV INDIANAPOLIS
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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 six groups of 6 youth per group 4 with ASD and 2 normally developing children have completed the first SST group and the seventh group is active in the trial due to complete 10 weeks of treatment in March 2012. We have a set schedule for 4 groups per year. We recently 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 nonglutamatergic drugs. In addition we have received IRB approval to add use of the Autism Diagnostic Observation Schedule to better characterize ASD pathology.