Sikich 2013.

Study characteristics
Methods	Parallel trial of oxytocin versus placebo
Participants	Inclusion criteria: ASD diagnosis based on DSM‐4 criteria male or female outpatients aged 18‐60 years CGI–S score ≥ 4 (moderately ill) on stable pharmacologic and nonpharmacologic treatments for at least 3 months normal physical examination full‐scale IQ > 70 sexually active women had to be on two barrier methods of contraception and no hormonal birth control Exclusion criteria: prematurity primary axis 1 disorders such as bipolar disorder, psychosis, post‐traumatic stress disorder, schizophrenia, or major depressive disorder/ anxiety disorder history of significant neurological disease including, but not limited to, unstable epilepsy disorder, known genetic syndromes, or known abnormal brain magnetic resonance imaging, or history of malignancy or any significant haematological, endocrine, cardiovascular (including any rhythm disorder), respiratory, renal, hepatic, or gastrointestinal disease unable to tolerate venipuncture procedures Location/setting: not stated Sample size: 25 (12 in oxytocin/oxytocin sequence; 13 in placebo/oxytocin) Number of withdrawals/dropouts: 1 in oxytocin/oxytocin group due to AEs Gender: oxytocin 12/12 were male; placebo 11/13 were male Mean age: oxytocin 10.6 years; placebo 10.0 years IQ: oxytocin: 4/12 had IQ < 70; placebo 10/13 had IQ < 70 Baseline ABC‐I or other BoC: not reported Concurrent medications: details not provided History of previous medications: details not provided
Interventions	Intervention (oxytocin) for 6 weeks: oxytocin (Syntocinon; NOVARTIS) dosage was up to 32 IU (8 intranasal spray puffs) twice‐daily for 6 weeks. Participants aged 3‐10 years titrated up to a maximum dose of 24 IU. Participants aged 11‐17 years titrated up to a maximum dose of 32 IU Comparator (placebo) for 6 weeks: placebo nasal spray
Outcomes	Primary outcomes: AEs Secondary outcomes: none reported Timing of outcome assessments: not reported
Notes	Study start date: March 2011 Study end date: April 2013 Source of funding: University of North Carolina, Chapel Hill Autism Speaks, USA Conflicts of interest: none declared Trial registry: NCT01944046
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "a computer generated randomization table was created by the research pharmacist and used to randomise participants"
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	Low risk	Quote: "All efficacy assessments were carried out by an independent evaluator who was blinded to both side effects and group assignment"
Incomplete outcome data (attrition bias) All outcomes	Low risk	All participants were analysed using an ITT analysis and baseline and endpoint QoL scores were recorded.
Selective reporting (reporting bias)	Low risk	The primary and secondary outcomes of interest were recorded on clinicaltrials.gov and all results were provided.
Other bias	Unclear risk	No significant differences in gender, race, age. Perhaps a slight difference in IQ ‐ oxytocin group 99 (22) and placebo 118 (19) however, several study authors are connected to many pharmaceutical companies.