ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 68 of 256 for:    postpartum | "Depression"

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02505984
Recruitment Status : Recruiting
First Posted : July 22, 2015
Last Update Posted : July 27, 2018
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

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.

Condition or disease Intervention/treatment Phase
Depression, Postpartum Anxiety Drug: Oxytocin Drug: Placebo Phase 2

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Testing the Efficacy of Intranasal Oxytocin for the Prevention of Postpartum Depression and PTSD
Study Start Date : October 2015
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin

Arm Intervention/treatment
Active Comparator: Oxytocin
Sub-group of participants receiving oxytocin nasal spray (Syntocinon)
Drug: Oxytocin
Study participants will be randomized to a placebo or drug group.
Other Name: Syntocinon

Placebo Comparator: Placebo
Sub-group of participants receiving placebo nasal spray
Drug: Placebo
Study participants will be randomized to a placebo or drug group.
Other Name: Salt solution




Primary Outcome Measures :
  1. 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



Secondary Outcome Measures :
  1. Change in depression symptoms [ Time Frame: Baseline and day 5 postpartum ]
    Self-reported severity of depression symptoms

  2. Change in anxiety symptoms [ Time Frame: Baseline and day 5 postpartum ]
    Self-reported severity of anxiety symptoms

  3. Child development [ Time Frame: 2 months postpartum ]
    Quantitative observational assessment of infant socio-emotional, cognitive, and motor development



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02505984


Contacts
Contact: Sharon Dekel, PhD 617-726-1352 sdekel@mgh.harvard.edu

Locations
United States, Massachusetts
Massachusetts General Hosptial Recruiting
Boston, Massachusetts, United States, 02114
Contact: Sharon Dekel, PhD    617-726-1352    sdekel@mgh.harvard.edu   
Sponsors and Collaborators
Massachusetts General Hospital
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Sharon Dekel, PhD Massachusetts General Hosptial

Publications:
Responsible Party: Sharon Dekel, PhD, Assistant Professor in Psychology, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02505984     History of Changes
Other Study ID Numbers: 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 )
First Posted: July 22, 2015    Key Record Dates
Last Update Posted: July 27, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Sharon Dekel, PhD, Massachusetts General Hospital:
oxytocin, bonding
child development

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depression, Postpartum
Puerperal Disorders
Behavioral Symptoms
Mood Disorders
Mental Disorders
Pregnancy Complications
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs