Clinical trial NCT04745494: Studies of Mothers With Postnatal Depression
Official title: Studies of Mothers With Postnatal Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postnatal Depression
Keywords: Oxytocin
Lead sponsor: University College, London
Sponsor class: OTHER
First posted: 2021-02-09
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Double-blind, placebo-controlled, case-controlled, randomised controlled-trial, within-subjects, cross-over design.
Primary purpose: BASIC_SCIENCE

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* All mothers will be aged ≥18 years old.
* 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 mother is younger than 18 or post-menopausal
* 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

Primary outcomes:
measure: Change in maternal mood
timeFrame: Baseline, 35-45 minutes after intervention administration
Secondary outcomes:
measure: Change in maternal mindmindedness
timeFrame: Baseline, 35-45 minutes after intervention administration
measure: Change in mother-infant interactional style
timeFrame: Baseline, 35-45 minutes after intervention administration
measure: Change in maternal OT
timeFrame: Baseline, 35-45 minutes after intervention administration
measure: Change in infant OT
timeFrame: Baseline, 35-45 minutes after intervention administration
measure: Maternal gaze during interaction with her infant
timeFrame: 35-45 minutes after intervention administration
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: University College London
state: UK
Study officials:
References:
citation: 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.