A randomized, placebo-controlled trial of D-cycloserine for the enhancement of social skills training in autism spectrum disorders.

Noha F Minshawi,Rebecca Shaffer,Christopher J Mcdougle,Craig A Erickson,Hai Liu,Martin H Plawecki,Sarah Hurwitz,Naomi B Swiezy,David J Posey,Logan K Wink

doi:10.1186/s13229-015-0062-8

Abstract

BackgroundResearchers have demonstrated that d-cycloserine (DCS) can enhance the effects of behavioral interventions in adults with anxiety and enhances prosocial behavior in animal models of autism spectrum disorders (ASD). This study extended upon this background by combining DCS with behavioral social skills therapy in youth with ASD to assess its impact on the core social deficits of ASD. We hypothesized that DCS used in combination with social skills training would enhance the acquisition of social skills in children with ASD.MethodsA 10-week, double-blind, placebo-controlled trial of DCS (50 mg) given 30 min prior to weekly group social skills training was conducted at two sites. Children with ASD were randomized to receive 10 weeks (10 doses) of DCS or placebo in a 1:1 ratio.ResultsNo statistically significant difference attributable to drug treatment was observed in the change scores for the primary outcome measure, the Social Responsiveness Scale (SRS), total score (p = 0.45), or on secondary outcome measures.ConclusionsThe results of this trial demonstrated no drug-related short-term improvement on the primary outcome measure, or any of the secondary outcome measures. However, an overall significant improvement in SRS total raw score was observed from baseline to end of treatment for the entire group of children with ASD. This suggests a need to further study the efficacy of the social skills training protocol. Limitations to the current study and areas for future research are discussed.Trial registrationClinicalTrials.govNCT01086475

Highlights

Researchers have demonstrated that D-cycloserine (DCS) can enhance the effects of behavioral interventions in adults with anxiety and enhances prosocial behavior in animal models of autism spectrum disorders (ASD)
Autism spectrum disorders (ASD), including autistic disorder, Asperger’s disorder, and pervasive developmental disorder not otherwise specified (PDD-NOS), have received increasing attention from researchers, clinicians, and the public since autism was first described by Leo Kanner in 1943 [1]
A parallel is frequently drawn between schizophrenia and ASD due to similarity between the negative symptoms of schizophrenia and social withdrawal seen in ASD, as well as the implication of glutamate dysregulation in both disorders [7]

Summary

Introduction

Researchers have demonstrated that D-cycloserine (DCS) can enhance the effects of behavioral interventions in adults with anxiety and enhances prosocial behavior in animal models of autism spectrum disorders (ASD). A parallel is frequently drawn between schizophrenia and ASD due to similarity between the negative symptoms of schizophrenia and social withdrawal seen in ASD, as well as the implication of glutamate dysregulation in both disorders [7]. In ASD, a single-blind pilot study of DCS in children and adults (mean age of 10 years) found that DCS was associated with a clinically significant reduction in social withdrawal and increase in social responsiveness compared to a placebo control [13]. A double-blind, placebo-controlled trial of daily dosing of DCS in 88 children with ASD found no significant difference in measures of social withdrawal or global severity ratings during 8 weeks of daily treatment [14]

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Results

Discussion

Conclusion