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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OT administration | Active Comparator | All participants will receive a single dose of 24IU OT (40.32µg, Syntocinon) delivered via a nasal spray. |
|
| Placebo administration | Placebo Comparator | All participants will receive a single dose of a placebo delivered via a nasal spray. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OT administration | Other | OT nasal administration |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University College London | London | UK | WC1E 7HB | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34843839 | Derived | 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. |
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| ID | Term |
|---|---|
| D019052 | Depression, Postpartum |
| ID | Term |
|---|---|
| D011644 | Puerperal Disorders |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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Double-blind, placebo-controlled, case-controlled, randomised controlled-trial, within-subjects, cross-over design.
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| Placebo administration |
| Other |
Placebo nasal administration |
|
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 |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |