Studies of Mothers With Postnatal Depression

NCT04745494 | Completed

• 1 other identifier: 16/0679
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Postnatal Depression

Keywords

Oxytocin

Outcome Measures

Primary Outcomes (1)

• Change in maternal mood

  Change in maternal mood will be assessed using the PANAS questionnaire

  Baseline, 35-45 minutes after intervention administration

Secondary Outcomes (5)

• Change in maternal mindmindedness

  Baseline, 35-45 minutes after intervention administration

• Change in mother-infant interactional style

  Baseline, 35-45 minutes after intervention administration

• Change in maternal OT

  Baseline, 35-45 minutes after intervention administration

• Change in infant OT

  Baseline, 35-45 minutes after intervention administration

• Maternal gaze during interaction with her infant

  35-45 minutes after intervention administration

Study Arms (2)

OT administration

ACTIVE COMPARATOR

All participants will receive a single dose of 24IU OT (40.32µg, Syntocinon) delivered via a nasal spray.

Other: OT administration

Placebo administration

PLACEBO COMPARATOR

All participants will receive a single dose of a placebo delivered via a nasal spray.

Other: Placebo administration

Interventions

OT administration OTHER

OT nasal administration

OT administration

Placebo administration OTHER

Placebo nasal administration

Placebo administration

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University College, London: lead

Study Sites (1)

University College London

London, UK, WC1E 7HB, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 34843839 DERIVED

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double-blind, placebo-controlled, case-controlled, randomised controlled-trial, within-subjects, cross-over design.

Study Record Dates

• First Submitted: March 25, 2020
• First Posted: February 9, 2021
• Study Start: May 12, 2017
• Primary Completion: March 15, 2020
• Study Completion: January 30, 2021
• Last Updated: February 9, 2021

Record last verified: 2021-02

Locations

GB (1)