Bernaerts 2020.
Study characteristics | ||
Methods | 4‐week parallel trial of oxytocin versus placebo | |
Participants | Inclusion criteria:
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 |
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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) |
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Outcomes | Primary outcomes: AEs Secondary outcomes: QoL (change from baseline) measured using the WHO QoL scale (WHO 1998) |
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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) |
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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 |