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).

Study Overview

• Status: Completed
• Conditions: Postnatal Depression
• Intervention / Treatment: Other: OT administration; Other: Placebo administration

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • UK
    • London, UK, United Kingdom, WC1E 7HB
      • University College London

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: OT administration; All participants will receive a single dose of 24IU OT (40.32µg, Syntocinon) delivered via a nasal spray.	Other: OT administration; OT nasal administration
Placebo Comparator: Placebo administration; All participants will receive a single dose of a placebo delivered via a nasal spray.	Other: Placebo administration; Placebo nasal administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in maternal mood	Change in maternal mood will be assessed using the PANAS questionnaire	Baseline, 35-45 minutes after intervention administration

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University College, London

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2017
• Primary Completion (Actual): March 15, 2020
• Study Completion (Actual): January 30, 2021

Study Registration Dates

• First Submitted: March 25, 2020
• First Submitted That Met QC Criteria: February 8, 2021
• First Posted (Actual): February 9, 2021

Study Record Updates

• Last Update Posted (Actual): February 9, 2021
• Last Update Submitted That Met QC Criteria: February 8, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Oxytocin
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Pregnancy Complications; Puerperal Disorders; Depression; Depressive Disorder; Depression, Postpartum
• Other Study ID Numbers: 16/0679

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No