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

Bernaerts 2020.

Study characteristics
Methods 4‐week parallel trial of oxytocin versus placebo
Participants Inclusion criteria:
  • diagnosis of ASD based on DSM‐4‐TR

  • male

  • aged 18‐35 years


Exclusion criteria: any neurological or genetic disorder, or contraindication for MRI
Location/ setting: autism centre at the Leuven University Hospital, Belgium
Sample size: oxytocin 22; placebo 18
Reasons for dropouts/withdrawal: the reason was not provided for the 1 participant from the placebo group who was not included in the analysis.
Mean IQ: approx 103 for both groups
Mean age: 24.5 years
Gender: details not provided
Baseline ABC‐I or other BoC scale: oxytocin: WHO QoL 82.91 (14.04); placebo 85.24 (9.63)
Concomitant medications: 6/22 in oxytocin group were on psychostimulants. Other medications included antidepressants, aripiprazole, unspecified antipsychotics and carbamazepine (Tegretol). 2/18 in placebo group were on psychostimulants. Other medications included antidepressants, and risperidone.
Previous medications ‐ not reported
Interventions Intervention (oxytocin): 4 weeks of intranasal oxytocin (24 IU), once daily in the morning
Comparator (placebo): nasal spray for 4 weeks, once daily in the morning
Timing of outcome assessments: baseline and endpoint (4 weeks)
Outcomes Primary outcomes: AEs
Secondary outcomes: QoL (change from baseline) measured using the WHO QoL scale (WHO 1998)
Notes Study start date: April 2015
Study end date: December 2016
Funding: this research was supported by the Branco Weiss fellowship of the Society in Science ‐ ETH Zurich and by grants from the Flanders Fund for Scientific Research (FWO projects KAN 1506716N, KAN 1521313N, G040112 & G079017N).
Conflicts of interest: S.B. is supported by a fund of the Marguerite‐Marie Delacroix foundation.
Trial registry: European Clinical Trial Registry (Eudract 2014‐000586‐45)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated randomised order
Allocation concealment (selection bias) Unclear risk Details regarding allocation concealment not provided
Blinding of participants and personnel (performance bias)
All outcomes Low risk Except for the manager of randomisation, all research staff conducting the trial, participants, and their parents and/or partners were blinded to treatment allocation.
Blinding of outcome assessment (detection bias)
All outcomes Low risk Except for the manager of randomisation, all research staff conducting the trial, participants, and their parents and/or partners were blinded to treatment allocation.
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Data were analysed using an ITT format with LOCF to replace missing data
Selective reporting (reporting bias) Low risk All primary and secondary outcomes listed on clinical registry were reported.
Other bias Low risk No other obvious sources of bias identified