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. 2023 Oct 9;2023(10):CD011769. doi: 10.1002/14651858.CD011769.pub2

NCT02940574.

Study characteristics
Methods 4‐week trial of oxytocin versus placebo
Participants Inclusion criteria:
  • clinical diagnosis of ASD, Asperger's Syndrome or Autism

  • male

  • aged 18‐40 years


Exclusion criteria:
  • associated neuro(psycho)logical disorder (i.e. epilepsy, concussion, stroke), eyesight worse than + or ‐ 7, Genetic syndrome, colour blindness

  • any contraindication to neuroimaging research as assessed with the MRI screening list: pacemaker, implanted defibrillator, ear implant/a cochlear implant, insulin or implanted pump, a neurostimulator or ventriculoperitoneal shunt, any metallic object in the eyes (metallic fragments).


Location/setting: Belgium
Mean IQ: details not provided
Mean age: 18‐40 year olds
Gender: all participants were male.
Sample size: 40 (oxytocin 22, placebo 18)
Reasons for dropouts/withdrawals: 1 in oxytocin group withdrew from the study, 1 from placebo not included in analysis due to "excessive in‐scanner head motion"
Baseline ABC‐I or other BoC scale: not an outcome
Concomitant medications: details not provided
Previous medications: details not provided
Interventions Intervention (oxytocin) for 4 weeks: single dose of 24 IU oxytocin (Syntocinon) nasal spray (3 puffs of 4 IU per nostril), followed by 4 weeks of a daily single dose (24 IU; 3 puffs of 4 IU per nostril) of nasal spray.
Comparator (placebo) for 4 weeks: placebo (physiological water (solution of sodium chloride (NaCl) in water)) administered via nasal spray. A single dose (24 IU) of nasal spray (3 puffs of 4 IU per nostril), followed by 4 weeks of a daily single dose (24 IU; 3 puffs of 4 IU per nostril) of nasal spray.
Outcomes Primary outcomes: AEs
Secondary outcomes:
  • QoL, measured using the WHO‐QoL (WHO 1998) (higher scores indicate a more positive response)

  • tolerability


Timing of outcome assessments: baseline and 4 weeks (endpoint)
Notes Study start date: October 2016
Study end date: February 2020
Funding: details not provided
Conflicts of interest: details not provided
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Insufficient detail: "allocation: randomized"
Allocation concealment (selection bias) Unclear risk Insufficient detail. Quote: "allocation: randomised"
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Only details provided were on the trials registry
Quote: "masking: quadruple (participant, care provider, investigator, outcomes assessor)"
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Only details provided were on the trials registry
Quote: "masking: quadruple (participant, care provider, investigator, outcomes assessor)"
Incomplete outcome data (attrition bias)
All outcomes Low risk Quote: "1 subject lost in Syntocinon group due to subject withdrawal. 1 subject lost in placebo group due to low data quality (excessive in‐scanner head motion)"
Selective reporting (reporting bias) Unclear risk Difficult to know without a protocol
Other bias Low risk No other apparent sources of bias