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OpenTrials
Completed

NCT Number: NCT04745494

Studies of Mothers With Postnatal Depression

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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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University College London

London, UK, WC1E 7HB, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OT administration

Other

OT nasal administration

Placebo Administration

Other

Placebo nasal administration

Primary outcomes

  1. Change in maternal mood

    Time frame: Baseline, 35-45 minutes after intervention administration

    Change in maternal mood will be assessed using the PANAS questionnaire

Secondary outcomes

  1. Change in maternal mindmindedness

    Time frame: Baseline, 35-45 minutes after intervention administration

    Change in maternal mindmindedness will be assessed using Meins' Mindmindedness Manual

  2. Change in mother-infant interactional style

    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

  3. Change in maternal OT

    Time frame: Baseline, 35-45 minutes after intervention administration

    Change in maternal salivary and breast milk OT will be assayed

  4. Change in infant OT

    Time frame: Baseline, 35-45 minutes after intervention administration

    Change in infant salivary OT will be assayed

  5. Maternal gaze during interaction with her infant

    Time frame: 35-45 minutes after intervention administration

    Maternal gaze will be assessed using a Tobii X2-30 eye tracker

Sponsors and collaborators

Lead sponsor

University College, London

Other

Registry information

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
Feb 9, 2021
Registry last updated
Feb 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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