Postnatal Depression
Conditions
Keywords
Oxytocin
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.
Interventions
OTHEROT administration
OT nasal administration
OTHERPlacebo administration
Placebo nasal administration
Sponsors
University College, London
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Double-blind, placebo-controlled, case-controlled, randomised controlled-trial, within-subjects, cross-over design.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in maternal mood | Baseline, 35-45 minutes after intervention administration | Change in maternal mood will be assessed using the PANAS questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in maternal mindmindedness | Baseline, 35-45 minutes after intervention administration | Change in maternal mindmindedness will be assessed using Meins' Mindmindedness Manual |
| Change in mother-infant interactional style | Baseline, 35-45 minutes after intervention administration | Change in mother-infant interactional style will be coded using Feldman's Coding Interactive Behaviour Manual |
| Change in maternal OT | Baseline, 35-45 minutes after intervention administration | Change in maternal salivary and breast milk OT will be assayed |
| Change in infant OT | Baseline, 35-45 minutes after intervention administration | Change in infant salivary OT will be assayed |
| Maternal gaze during interaction with her infant | 35-45 minutes after intervention administration | Maternal gaze will be assessed using a Tobii X2-30 eye tracker |
Countries
United Kingdom
Outcome results
None listed