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Preventing Postpartum Depression With Intranasal Oxytocin (IN-OXT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02505984
Recruitment Status : Active, not recruiting
First Posted : July 22, 2015
Last Update Posted : April 30, 2021
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Sharon Dekel, PhD, Massachusetts General Hospital

Tracking Information
First Submitted Date  ICMJE July 19, 2015
First Posted Date  ICMJE July 22, 2015
Last Update Posted Date April 30, 2021
Study Start Date  ICMJE October 2015
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 26, 2018)
Treatment effect on mother-infant bonding [ Time Frame: Day 5 postpartum and 2 months postpartum ]
Day 5 postpartum: Self-report assessment of maternal bonding 2 months postpartum: Quantitative observational assessment of mother-infant bonding and repeat of self-reports
Original Primary Outcome Measures  ICMJE
 (submitted: July 21, 2015)
Depression symptoms [ Time Frame: Day 5 postpartum ]
Edinburgh Postnatal Depression Scale (EPDS)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 26, 2018)
  • Change in depression symptoms [ Time Frame: Baseline and day 5 postpartum ]
    Self-reported severity of depression symptoms
  • Change in anxiety symptoms [ Time Frame: Baseline and day 5 postpartum ]
    Self-reported severity of anxiety symptoms
  • Child development [ Time Frame: 2 months postpartum ]
    Quantitative observational assessment of infant socio-emotional, cognitive, and motor development
Original Secondary Outcome Measures  ICMJE
 (submitted: July 21, 2015)
  • Mother-infant bonding [ Time Frame: Day 5 postpartum ]
    Postpartum Bonding Inventory
  • Posttraumatic stress symptoms [ Time Frame: Day 5 postpartum ]
    PTSD checklist for DSM 5
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Preventing Postpartum Depression With Intranasal Oxytocin
Official Title  ICMJE Testing the Efficacy of Intranasal Oxytocin for the Prevention of Postpartum Depression and PTSD
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Depression, Postpartum
  • Anxiety
Intervention  ICMJE
  • Drug: Oxytocin
    Study participants will be randomized to a placebo or drug group.
    Other Name: Syntocinon
  • Drug: Placebo
    Study participants will be randomized to a placebo or drug group.
    Other Name: Salt solution
Study Arms  ICMJE
  • Active Comparator: Oxytocin
    Sub-group of participants receiving oxytocin nasal spray (Syntocinon)
    Intervention: Drug: Oxytocin
  • Placebo Comparator: Placebo
    Sub-group of participants receiving placebo nasal spray
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: July 21, 2015)
110
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2022
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02505984
Other Study ID Numbers  ICMJE 2015P001100
224421 ( Other Grant/Funding Number: Claflin Distinguished Scholar Award )
225686 ( Other Grant/Funding Number: Brain & Behavior Research Foundation )
1R21HD090396-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Sharon Dekel, PhD, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators  ICMJE
Principal Investigator: Sharon Dekel, PhD Massachusetts General Hosptial
PRS Account Massachusetts General Hospital
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP