Anxiety Clinical Trial
— IN-OXTOfficial title:
Testing the Efficacy of Intranasal Oxytocin for the Prevention of Postpartum Depression and PTSD
Verified date | May 2023 |
Source | Massachusetts General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to test a new treatment for preventing childbirth-related mental illness in postpartum mothers. The treatment is aimed at enhancing maternal bonding, reducing postpartum depression (PPD) and anxiety in mothers at risk, and promoting child development. To this end, the investigators will test the clinical utility of intranasal (IN) oxytocin (OXT) administered to mothers during the first postpartum days.
Status | Completed |
Enrollment | 56 |
Est. completion date | May 2023 |
Est. primary completion date | May 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 50 Years |
Eligibility | Inclusion Criteria: - Third-trimester pregnant women being followed at the MGH Obstetrics Program - At risk of postpartum depression (PPD) Exclusion Criteria: - Failure to participate in regular prenatal check-ups - Current diagnosis DSM-5 mental disorder pertaining to psychosis or substance abuse - Suicidality - Obstetric complication (e.g., preeclampsia, excessive hemorrhaging) - Use of potentially confounding or interacting medications - Complicating pediatric medical condition in the newborn |
Country | Name | City | State |
---|---|---|---|
United States | Massachusetts General Hosptial | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
United States,
Fewtrell MS, Loh KL, Blake A, Ridout DA, Hawdon J. Randomised, double blind trial of oxytocin nasal spray in mothers expressing breast milk for preterm infants. Arch Dis Child Fetal Neonatal Ed. 2006 May;91(3):F169-74. doi: 10.1136/adc.2005.081265. Epub 2005 Oct 13. — View Citation
Jobst A, Krause D, Maiwald C, Hartl K, Myint AM, Kastner R, Obermeier M, Padberg F, Brucklmeier B, Weidinger E, Kieper S, Schwarz M, Zill P, Muller N. Oxytocin course over pregnancy and postpartum period and the association with postpartum depressive symptoms. Arch Womens Ment Health. 2016 Aug;19(4):571-9. doi: 10.1007/s00737-016-0644-2. Epub 2016 Jun 20. — View Citation
Mah BL, Bakermans-Kranenburg MJ, Van IJzendoorn MH, Smith R. Oxytocin promotes protective behavior in depressed mothers: a pilot study with the enthusiastic stranger paradigm. Depress Anxiety. 2015 Feb;32(2):76-81. doi: 10.1002/da.22245. Epub 2014 Feb 12. — View Citation
Riem MM, Bakermans-Kranenburg MJ, Pieper S, Tops M, Boksem MA, Vermeiren RR, van Ijzendoorn MH, Rombouts SA. Oxytocin modulates amygdala, insula, and inferior frontal gyrus responses to infant crying: a randomized controlled trial. Biol Psychiatry. 2011 Aug 1;70(3):291-7. doi: 10.1016/j.biopsych.2011.02.006. Epub 2011 Apr 5. Erratum In: Biol Psychiatry. 2012 Apr 1;71(7):660. — View Citation
Skrundz M, Bolten M, Nast I, Hellhammer DH, Meinlschmidt G. Plasma oxytocin concentration during pregnancy is associated with development of postpartum depression. Neuropsychopharmacology. 2011 Aug;36(9):1886-93. doi: 10.1038/npp.2011.74. Epub 2011 May 11. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Treatment effect on mother-infant bonding | Day 5 postpartum:
Self-report assessment of maternal bonding 2 months postpartum: Quantitative observational assessment of mother-infant bonding and repeat of self-reports |
Day 5 postpartum and 2 months postpartum | |
Secondary | Change in depression symptoms | Self-reported severity of depression symptoms | Baseline and day 5 postpartum | |
Secondary | Change in anxiety symptoms | Self-reported severity of anxiety symptoms | Baseline and day 5 postpartum | |
Secondary | Child development | Quantitative observational assessment of infant socio-emotional, cognitive, and motor development | 2 months postpartum |
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