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Studies of Mothers With Postnatal Depression

Primary Purpose

Postnatal Depression

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
OT administration
Placebo administration
Sponsored by
University College, London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Postnatal Depression focused on measuring Oxytocin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University College London

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

OT administration

Placebo administration

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in maternal mood
Change in maternal mood will be assessed using the PANAS questionnaire

Secondary Outcome Measures

Change in maternal mindmindedness
Change in maternal mindmindedness will be assessed using Meins' Mindmindedness Manual
Change in mother-infant interactional style
Change in mother-infant interactional style will be coded using Feldman's Coding Interactive Behaviour Manual
Change in maternal OT
Change in maternal salivary and breast milk OT will be assayed
Change in infant OT
Change in infant salivary OT will be assayed
Maternal gaze during interaction with her infant
Maternal gaze will be assessed using a Tobii X2-30 eye tracker

Full Information

First Posted
March 25, 2020
Last Updated
February 8, 2021
Sponsor
University College, London
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1. Study Identification

Unique Protocol Identification Number
NCT04745494
Brief Title
Studies of Mothers With Postnatal Depression
Official Title
Studies of Mothers With Postnatal Depression
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
May 12, 2017 (Actual)
Primary Completion Date
March 15, 2020 (Actual)
Study Completion Date
January 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University College, London

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postnatal Depression
Keywords
Oxytocin

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Double-blind, placebo-controlled, case-controlled, randomised controlled-trial, within-subjects, cross-over design.
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OT administration
Arm Type
Active Comparator
Arm Description
All participants will receive a single dose of 24IU OT (40.32µg, Syntocinon) delivered via a nasal spray.
Arm Title
Placebo administration
Arm Type
Placebo Comparator
Arm Description
All participants will receive a single dose of a placebo delivered via a nasal spray.
Intervention Type
Other
Intervention Name(s)
OT administration
Intervention Description
OT nasal administration
Intervention Type
Other
Intervention Name(s)
Placebo administration
Intervention Description
Placebo nasal administration
Primary Outcome Measure Information:
Title
Change in maternal mood
Description
Change in maternal mood will be assessed using the PANAS questionnaire
Time Frame
Baseline, 35-45 minutes after intervention administration
Secondary Outcome Measure Information:
Title
Change in maternal mindmindedness
Description
Change in maternal mindmindedness will be assessed using Meins' Mindmindedness Manual
Time Frame
Baseline, 35-45 minutes after intervention administration
Title
Change in mother-infant interactional style
Description
Change in mother-infant interactional style will be coded using Feldman's Coding Interactive Behaviour Manual
Time Frame
Baseline, 35-45 minutes after intervention administration
Title
Change in maternal OT
Description
Change in maternal salivary and breast milk OT will be assayed
Time Frame
Baseline, 35-45 minutes after intervention administration
Title
Change in infant OT
Description
Change in infant salivary OT will be assayed
Time Frame
Baseline, 35-45 minutes after intervention administration
Title
Maternal gaze during interaction with her infant
Description
Maternal gaze will be assessed using a Tobii X2-30 eye tracker
Time Frame
35-45 minutes after intervention administration

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
University College London
City
London
State/Province
UK
ZIP/Postal Code
WC1E 7HB
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
34843839
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.
Results Reference
derived

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Studies of Mothers With Postnatal Depression

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