Studies of Mothers With Postnatal Depression

Not Applicable

Completed

• Conditions: Postnatal Depression
• Interventions: Other: OT administration; Other: Placebo administration

• Registration Number: NCT04745494
• Lead Sponsor: University College, London

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.

Study Timeline

• Study Start: 2017-05-12
• Primary Completion: 2020-03-15
• Study First Submitted: 2020-03-25
• Study Completion: 2021-01-30
• Status Verified: 2021-02
• Study First Submitted QC: 2021-02-08
• Last Update Submitted: 2021-02-08
• Study First Posted: 2021-02-09
• Last Update Posted: 2021-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
OT administration	OT administration	All participants will receive a single dose of 24IU OT (40.32µg, Syntocinon) delivered via a nasal spray.
Placebo administration	Placebo administration	All participants will receive a single dose of a placebo delivered via a nasal spray.

Primary Outcome Measures

Name	Time	Method
Change in maternal mood	Baseline, 35-45 minutes after intervention administration	Change in maternal mood will be assessed using the PANAS questionnaire

Secondary Outcome Measures

Name	Time	Method
Change in mother-infant interactional style	Baseline, 35-45 minutes after intervention administration	Change in mother-infant interactional style will be coded using Feldman's Coding Interactive Behaviour Manual
Change in maternal OT	Baseline, 35-45 minutes after intervention administration	Change in maternal salivary and breast milk OT will be assayed
Change in infant OT	Baseline, 35-45 minutes after intervention administration	Change in infant salivary OT will be assayed
Change in maternal mindmindedness	Baseline, 35-45 minutes after intervention administration	Change in maternal mindmindedness will be assessed using Meins' Mindmindedness Manual
Maternal gaze during interaction with her infant	35-45 minutes after intervention administration	Maternal gaze will be assessed using a Tobii X2-30 eye tracker

Trial Locations

Locations (1)

University College London; 🇬🇧 London, UK, United Kingdom