NCT02940574.
Study characteristics | ||
Methods | 4‐week trial of oxytocin versus placebo | |
Participants | Inclusion criteria:
Exclusion criteria:
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 |
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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. |
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Outcomes | Primary outcomes: AEs Secondary outcomes:
Timing of outcome assessments: baseline and 4 weeks (endpoint) |
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Notes | Study start date: October 2016 Study end date: February 2020 Funding: details not provided Conflicts of interest: details not provided |
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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 |