NCT01337687.
Study characteristics | ||
Methods | 6‐week parallel trial of oxytocin versus placebo | |
Participants | Inclusion criteria:
Exclusion criteria:
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 |
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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 |
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Outcomes | Primary outcomes: AEs Secondary outcomes: none reported Timing of outcome assessments: baseline and 6 weeks (endpoint) |
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Notes | Study start date: April 2011 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 | 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 |