Skip to main content
. 2023 Oct 9;2023(10):CD011769. doi: 10.1002/14651858.CD011769.pub2

NCT01337687.

Study characteristics
Methods 6‐week parallel trial of oxytocin versus placebo
Participants Inclusion criteria:
  • male or female

  • 18‐55 years

  • meet DSM‐4, ADOS, and ADI‐R standards for ASD or Asperger's Syndrome

  • have a high, normal or near normal IQ

  • speak and understand English fluently


Exclusion criteria:
  • born prior to 35 weeks' gestational age

  • any psychiatric diagnosis apart from autism

  • any neurological disorders

  • known MRI/structural lesion of the brain

  • pregnant

  • taking psychoactive medication

  • evidence or history of a significant haematological, endocrine, cardiovascular, respiratory, renal, hepatic or gastrointestinal disease

  • planning to initiate or change medications during the trial

  • unable to tolerate blood sampling


Location/setting: Montefiore Medical Center, USA
Mean IQ: not reported
Mean age: 33.2 years
Gender: 16 male, 3 female
Sample size: 19 in total
Reasons for dropouts/withdrawals: none reported
Baseline ABC‐I or other BoC scale: not reported
Concomitant medications: details not provided
Previous medications: details not provided
Interventions Intervention (oxytocin) for 6 weeks: administered intranasally twice a day via 1 x 12 unit puff to each nostril, totalling 48 IU a day
Comparator (saline) for 6 weeks: administered intranasally twice a day via 1 puff per nostril, totalling 48 IU a day
Outcomes Primary outcomes: AEs
Secondary outcomes: none reported
Timing of outcome assessments: baseline and 6 weeks (endpoint)
Notes Study start date: April 2011
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 Details not provided
Allocation concealment (selection bias) Unclear risk Details not provided
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Only details provided were on the trial registry, "Masking: quadruple (participant, care provider, investigator, outcomes assessor)"
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Only details provided were on the trial registry, "Masking: quadruple (participant, care provider, investigator, outcomes assessor)"
Incomplete outcome data (attrition bias)
All outcomes Low risk No dropout reported
Selective reporting (reporting bias) Unclear risk No peer‐reviewed paper
Other bias Low risk No other sources of bias identified