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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04745494
Other study ID # 16/0679
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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