Preventing Postpartum Depression With Intranasal Oxytocin

Anxiety Clinical Trial

— IN-OXT  

Official title:

Testing the Efficacy of Intranasal Oxytocin for the Prevention of Postpartum Depression and PTSD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02505984
• Other study ID #: 2015P001100
• Secondary ID: 2244212256861R21
• Status: Completed
• Phase: Phase 2
• Start date: October 2015
• Est. completion date: May 2023

Study information

• Verified date: May 2023
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Postpartum depression (PPD) is a debilitating disorder which imposes a threat to mother and infant health. An estimated 600,000 American women suffer from PPD annually, making it one of the most frequent complications of pregnancy. Available secondary preventive interventions are often ineffective, which calls for identifying novel means for prevention. Impaired mother-infant bonding is a hallmark of PPD. Depressed mothers may have difficulties developing maternal feelings and providing sensitive care. In turn, impaired bonding may worsen mother's depression. Conventional pharmacotherapy does not help with bonding impairment.

This study will attempt to fill in the current gap in effective preventive interventions for pregnant mothers at risk. Evidence in postpartum mothers indicates that high peripartum OXT levels are associated with enhanced maternal behavior and low levels with depression. Data also indicates that in depressed mothers, OXT levels may decrease during the first days following childbirth rather than increase as is the norm. Therefore, the investigators will test the therapeutic effects of OXT in women at risk for PPD. It is hypothesized that administration of IN-OXT (total daily dose 48 IU) over the course of four days from as early as day one postpartum in comparison to placebo will 1) enhance mother-infant bonding, 2) reduce depressive and anxiety symptoms at 5 days postpartum, and 3) facilitate child development.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Anxiety
• Depression
• Depression, Postpartum
• Depressive Disorder

Intervention

Drug:
• Oxytocin
Study participants will be randomized to a placebo or drug group.
• Placebo
Study participants will be randomized to a placebo or drug group.

Locations

Country	Name	City	State
United States	Massachusetts General Hosptial	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

References & Publications (5)

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

Outcome

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