University College London
London, UK, WC1E 7HB, United Kingdom
NCT Number: NCT04745494
This study investigates the effects of a single dose of oxytocin (OT) delivered via a nasal spray in women with and without traits of postnatal depression (PND).
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Notify Me18 year and older
Female
Interventional
Not applicable
London, UK, WC1E 7HB, United Kingdom
A double-blind, placebo-controlled, case-controlled, randomised controlled-trial, within-subjects, cross-over design will be conducted.
Participants will include mothers and their infant in the postnatal period. All participants will be screened for symptoms of low mood on the Edinburgh Postnatal Depression Scale (EPDS) and then assigned into 2 groups comprising probable PND cases and controls.
All participants will take part in 3 conditions at Baseline (before nasal spray administration), Condition 1 (after first OT/Placebo administration) and Condition 2 (after second OT/Placebo administration), and will complete the same order of tasks.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
OT nasal administration
Placebo nasal administration
Time frame: Baseline, 35-45 minutes after intervention administration
Change in maternal mood will be assessed using the PANAS questionnaire
Time frame: Baseline, 35-45 minutes after intervention administration
Change in maternal mindmindedness will be assessed using Meins' Mindmindedness Manual
Time frame: Baseline, 35-45 minutes after intervention administration
Change in mother-infant interactional style will be coded using Feldman's Coding Interactive Behaviour Manual
Time frame: Baseline, 35-45 minutes after intervention administration
Change in maternal salivary and breast milk OT will be assayed
Time frame: Baseline, 35-45 minutes after intervention administration
Change in infant salivary OT will be assayed
Time frame: 35-45 minutes after intervention administration
Maternal gaze will be assessed using a Tobii X2-30 eye tracker
University College, London
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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