Minshawi 2016.

Study characteristics
Methods	Parallel trial of D‐cycloserine versus placebo
Participants	Inclusion criteria: diagnosis of ASD through administration of of the ADI‐R and clinical interview using the DSM‐4 criteria for ASD, Asperger's disorder, or PDD‐NOS Participants with ASD were required to have an IQ > 7 on the Stanford‐Binet 5th edition and a communication standard score > 70 on the Vineland Adaptive Behavior Scale 2nd edition. Triad Social Skills Assessment (TSSA) score of ≤ 70% on both parent questionnaire and child assessment significant social impairment as measured by a T score of ≥ 60 on the Social Responsiveness Scale (SRS) and CGI‐S of at least four (moderately ill). required to remain on stable psychotropic medication dosing targeting symptoms associated with ASD for a minimum of 2 weeks prior to randomisation Exclusion criteria: participants with diagnoses of Rett's disorder or childhood integrative disorder anyone who has recently had a significant change in their psychosocial interventions will not be eligible until this intervention has been stable for 90 days participants exhibiting significant disruptive, aggressive, self‐injurious, or sexually inappropriate behaviour the presence of current DSM‐4‐TR psychiatric disorders that require alternative pharmacotherapy or different treatment such as psychotic disorders, or major affective disorders participants with significant cardiac, hepatic, or renal disease, uncontrolled epilepsy or seizure disorders (seizures within the past 6 months) pregnant women, or female patients of child‐bearing age who do not agree to take birth control during the trial Location/setting: "Indiana University School of Medicine and Cincinnati Children’s Hospital Medical Center". Sample size: D‐cycloserine 34; placebo 33 Number of withdrawals/dropouts: no dropouts postrandomisation Gender: D‐cycloserine 28/34 male; placebo 27/33 male Mean age: D‐cycloserine 8.4 years; placebo 8.3 years IQ: D‐cycloserine 92.4; placebo 87.3 Baseline ABC‐I or other BoC: treatment: ABC‐I 11.06; placebo 12.67 Concomitant medications: antipsychotics 8/34, 8/33 placebo, alpha‐2 agonist 6/34, 8/33, stimulants 14/34 and 11/33, sleep aids 9/34 and 7/33, mood stabilisers 1 and 2, glutamatergic modulators 1 in D‐cycloserine group, other 3 and 1 History of previous medications: not reported
Interventions	D‐cycloserine for 10 weeks: given at a 50 mg dose 30 min prior to weekly group social skills training over 10 weeks Placebo for 10 weeks: placebo pill (sugar pill) administered 30 min prior to each of the 10 social skills training sessions
Outcomes	Primary outcomes: irritability, measured using the ABC‐I subscale (Aman 1985) AEs Secondary outcomes: none reported Timing of outcome assessments: baseline, week 6 and week 10 (endpoint)
Notes	Study start date: March 2010 Study end date: January 2014 Source of funding: "funding for this study was provided by the United States Department of Defense Award Number W81XWH‐09‐1‐0091." Conflicts of interest: none declared
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Children with ASD were randomised to receive 10 weeks (10 doses) of D‐cycloserine or placebo in a 1:1 ratio
Allocation concealment (selection bias)	Unclear risk	Details not provided
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Details not provided
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	No details on parents and teachers completing ABC questionnaire
Incomplete outcome data (attrition bias) All outcomes	Low risk	No dropouts were reported and all 67 were included in the analysis.
Selective reporting (reporting bias)	Low risk	Baseline and endpoint data reported for all outcomes mentioned
Other bias	Low risk	No significant group differences, or pharmaceutical company funding