Studies of Mothers With Postnatal Depression

Study Overview
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Brief Summary
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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
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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.

Official Title
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Studies of Mothers With Postnatal Depression

Conditions
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Postnatal Depression

Intervention / Treatment
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* Other: OT administration
* Other: Placebo administration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Double-blind, placebo-controlled, case-controlled, randomised controlled-trial, within-subjects, cross-over design.
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oxytocin