Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2017-05-12
2021-01-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
DOUBLE
Study Groups
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OT administration
All participants will receive a single dose of 24IU OT (40.32µg, Syntocinon) delivered via a nasal spray.
OT administration
OT nasal administration
Placebo administration
All participants will receive a single dose of a placebo delivered via a nasal spray.
Placebo administration
Placebo nasal administration
Interventions
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OT administration
OT nasal administration
Placebo administration
Placebo nasal administration
Eligibility Criteria
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Inclusion Criteria
* Mothers in the clinical group will score above the clinical cut-off point on the EPDS.
* Mothers in the control group will score below the clinical cut-off point on the EPDS.
* Mothers must be able to read and write English at a level sufficient to complete study related assessments.
Exclusion Criteria
* If the pregnancy was a result of fertility treatment
* If the mother is pregnant
* If the mother has history of psychotic illness
* If the mother is at risk of self-harm
* If the mother is involved in other active drug trials
18 Years
FEMALE
Yes
Sponsors
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University College, London
OTHER
Responsible Party
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Locations
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University College London
London, UK, United Kingdom
Countries
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References
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Lindley Baron-Cohen K, Feldman R, Fearon P, Fonagy P. Intranasal oxytocin administration improves mood in new mothers with moderate low mood but not in mothers with elevated symptoms of postnatal depression: A randomised controlled trial. J Affect Disord. 2022 Mar 1;300:358-365. doi: 10.1016/j.jad.2021.11.062. Epub 2021 Nov 26.
Other Identifiers
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16/0679
Identifier Type: -
Identifier Source: org_study_id
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