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

• Published in: Molecular autism Vol. 7; no. 3; p. 2
• Main Authors: Minshawi, Noha F, Wink, Logan K, Shaffer, Rebecca, Plawecki, Martin H, Posey, David J, Liu, Hai, Hurwitz, Sarah, McDougle, Christopher J, Swiezy, Naomi B, Erickson, Craig A
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 14-01-2016; BioMed Central
• Subjects: Anxiety; Autism; Autism Spectrum Disorder - drug therapy; Autism Spectrum Disorder - psychology; Autism Spectrum Disorder - therapy; Behavior modification; Behavior Therapy; Child; Child, Preschool; Children & youth; Cognition & reasoning; Complications and side effects; Cycloserine; Cycloserine - adverse effects; Cycloserine - therapeutic use; Dosage and administration; Double-Blind Method; Drug dosages; Drug therapy; Excitatory Amino Acid Agonists - adverse effects; Excitatory Amino Acid Agonists - therapeutic use; FDA approval; Feasibility studies; Female; Hospitals; Humans; Interpersonal Relations; Intervention; Learning - drug effects; Male; Parents - psychology; Peers; Pervasive developmental disorders; Physiological aspects; Schizophrenia; Severity of Illness Index; Skill development; Social aspects; Social research; Social Skills; Treatment Failure; United States; Autism spectrum disorders; Social skills training; Social deficits; d-cycloserine
• ISSN: 2040-2392; 2040-2392
• DOI: 10.1186/s13229-015-0062-8

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). 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.
A 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.
No 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.
The 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.
ClinicalTrials.govNCT01086475.