Munesue 2016.

Study characteristics
Methods	Cross‐over trial of oxytocin versus placebo
Participants	Inclusion criteria: ASD diagnosis based on DSM‐4 criteria male or female outpatients aged 15‐45 years CGI–S ≥ 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 2 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: outpatient setting of the Department of Child and Adolescent Psychiatry of Kanazawa University Hospital in Kanazawa, Japan Sample size: 29, 15 oxytocin‐placebo; 14 placebo‐oxytocin Number of withdrawals/dropouts: none reported Gender: all participants were male Mean age: range 15‐40 years IQ: oxytocin first: 24.9; placebo first: 37.5 Baseline ABC‐I or other BoC: ABC‐I oxytocin first: 11.9; placebo first: 17.4 Concomitant medications: not reported History of previous medications: 22 participants (75.9%) received psychotropic medications at stable doses during the 3 weeks prior to randomisation.
Interventions	Intervention (oxytocin) for 6 weeks: oxytocin dosage was 8 IU twice‐daily for 6 weeks (16 IU per day). Comparator (placebo) for 6 weeks: equivalent placebo
Outcomes	Primary outcomes: irritability, measured using the ABC‐I subscale (Aman 1985) AEs Secondary outcomes: WHOQOL (WHO 1998) Timing of outcome assessments: every 2 weeks
Notes	Study start date: February 2012 Study end date: October 2013 Source of funding: "this work was supported by the Strategic Research Program for Brain Sciences from the Ministry of Education, Culture, Sports, Science, and Technology, Japan (MEXT) and from the Japan Agency for Medical Research and Development and also by the Industry‐Academia Collaborative R&D Programs [Center of Innovation (COI) Program] from MEXT." Conflicts of interest: none declared Trial registry: UMIN000007250
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