Studies of Mothers With Postnatal Depression

Postnatal Depression Clinical Trial

Official title:

Studies of Mothers With Postnatal Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04745494
• Other study ID #: 16/0679
• Status: Completed
• Phase: N/A
• Start date: May 12, 2017
• Est. completion date: January 30, 2021

Study information

• Verified date: February 2021
• Source: University College, London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 30, 2021
• Est. primary completion date: March 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Depressive Disorder
• Postnatal Depression

Intervention

Other:
• OT administration
OT nasal administration
• Placebo administration
Placebo nasal administration

Locations

Country	Name	City	State
United Kingdom	University College London	London	UK

Sponsors (1)

Lead Sponsor	Collaborator
University College, London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in maternal mood	Change in maternal mood will be assessed using the PANAS questionnaire	Baseline, 35-45 minutes after intervention administration
Secondary	Change in maternal mindmindedness	Change in maternal mindmindedness will be assessed using Meins' Mindmindedness Manual	Baseline, 35-45 minutes after intervention administration
Secondary	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
Secondary	Change in maternal OT	Change in maternal salivary and breast milk OT will be assayed	Baseline, 35-45 minutes after intervention administration
Secondary	Change in infant OT	Change in infant salivary OT will be assayed	Baseline, 35-45 minutes after intervention administration
Secondary	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