Preventing Postpartum Depression With Intranasal Oxytocin

NCT ID: NCT02505984

Last Updated: 2025-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2023-05-31

Brief 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.

Detailed 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.

Conditions

Depression, Postpartum; Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Oxytocin

Sub-group of participants receiving oxytocin nasal spray (Syntocinon)

Group Type: ACTIVE_COMPARATOR

Oxytocin

Intervention Type: DRUG

Study participants will be randomized to a placebo or drug group.

Placebo

Sub-group of participants receiving placebo nasal spray

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Study participants will be randomized to a placebo or drug group.

Interventions

Oxytocin

Study participants will be randomized to a placebo or drug group.

Intervention Type: DRUG

Placebo

Study participants will be randomized to a placebo or drug group.

Intervention Type: DRUG

Other Intervention Names

Syntocinon; Salt solution

Eligibility Criteria

Inclusion Criteria

• Third-trimester pregnant women being followed at the Massachusetts General Hospital (MGH) Obstetrics Program
• At risk of postpartum depression (PPD)

Exclusion Criteria

• Failure to participate in regular prenatal check-ups
• Current diagnosis Diagnostic and Statistical Manual of Mental Disorders (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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sharon Dekel, PhD

Assistant Professor in Psychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sharon Dekel, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hosptial

Locations

Massachusetts General Hosptial

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 24523054 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21562482 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16223754 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21470595 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27320943 (View on PubMed)

Bertolini F, Robertson L, Bisson JI, Meader N, Churchill R, Ostuzzi G, Stein DJ, Williams T, Barbui C. Early pharmacological interventions for prevention of post-traumatic stress disorder (PTSD) in individuals experiencing acute traumatic stress symptoms. Cochrane Database Syst Rev. 2024 May 20;5(5):CD013613. doi: 10.1002/14651858.CD013613.pub2.

Reference Type: DERIVED

PMID: 38767196 (View on PubMed)

Bertolini F, Robertson L, Bisson JI, Meader N, Churchill R, Ostuzzi G, Stein DJ, Williams T, Barbui C. Early pharmacological interventions for universal prevention of post-traumatic stress disorder (PTSD). Cochrane Database Syst Rev. 2022 Feb 10;2(2):CD013443. doi: 10.1002/14651858.CD013443.pub2.

Reference Type: DERIVED

PMID: 35141873 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

224421

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

225686

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

1R21HD090396-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2015P001100

Identifier Type: -

Identifier Source: org_study_id