Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Intranasal Oxytocin and Maternal Neglect (OT-MOM)

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: NCT02737436
Recruitment Status : Unknown
Verified December 2016 by Robin Kochel, Baylor College of Medicine.
Recruitment status was:  Recruiting
First Posted : April 14, 2016
Last Update Posted : December 13, 2016
Sponsor:
Collaborator:
University of Iowa
Information provided by (Responsible Party):
Robin Kochel, Baylor College of Medicine

Brief Summary:

The investigators plan to conduct functional MRI scanning with a group of mothers who are blindly and randomly assigned either intranasal oxytocin or a placebo. The purpose of this investigation is to explore how oxytocin may modify early maternal brain and behavioral responses to infant cues. This study will examine, for the first time, a potential pharmacological intervention for maternal neglect which targets core neurobiological deficits. This may eventually be used to supplement and augment other psychosocial and behavioral interventions.

In addition, the investigators will examine sex differences in parental brain and behavioral responses to oxytocin by also recruiting the male partner of enrolled mothers to participate in a similar protocol.


Condition or disease Intervention/treatment Phase
Maternal Behavior Drug: Intranasal Oxytocin Drug: Placebo Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Intranasal Oxytocin: A Neuropharmacological Intervention for Maternal Neglect?
Study Start Date : May 2010
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin

Arm Intervention/treatment
Experimental: Oxytocin
Intranasal oxytocin (24IU) given 50 minutes prior to behavior assessment or scanning
Drug: Intranasal Oxytocin
Intranasal oxytocin (24IU) given 50 minutes prior to behavior assessment or scanning
Other Name: Syntocinon

Experimental: Placebo
Intranasal placebo spray given 50 minutes prior to behavior assessment or scanning
Drug: Placebo
Intranasal placebo spray given 50 minutes prior to behavior assessment or scanning




Primary Outcome Measures :
  1. Differences in brain activation of dopamine reward regions and prefrontal cortex after intranasal oxytocin administration in mothers [ Time Frame: 30 minutes after intranasal spray is administered ]
    Compared to placebo, mothers who receive intranasal oxytocin will show greater activation of mesocorticolimbic dopamine reward regions in the brain, including the ventral striatum and the medial prefrontal cortex, when viewing their own vs. unknown infant faces during fMRI scanning.

  2. Differences in brain activation of dopamine reward regions and prefrontal cortex after intranasal oxytocin administration in fathers [ Time Frame: 30 minutes after intranasal spray is administered ]
    Compared to placebo, fathers who receive intranasal oxytocin will show greater activation of social-cognitive circuits, including the dorsal prefrontal cortex (dPFC).



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.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

In order to fulfill enrollment criteria, the women must:

  1. be first-time parent(s)
  2. who have just delivered a term infant >37 weeks gestation, without medical complications.

    She should be:

  3. aged between 20 and 45 years;
  4. and be English speaking from childhood (required for accurate coding of attachment interview).

For male partners:

  1. First-time fathers;
  2. have female partners who just delivered a term infant >37 weeks gestation, without medical complications;
  3. aged between 20 and 45 years;
  4. English speaking from childhood

Exclusion Criteria:

Those who meet the following, will be excluded:

  1. History of head injury resulting in loss of consciousness for >10 minutes;
  2. neurological disease, including stroke, brain tumor, meningitis or encephalitis;
  3. any contraindications to MRI scanning, e.g. pacemakers, aneurysm clips, neurostimulators, fixed hearing devices, metal in eyes, or other implants;
  4. previous inability to tolerate MRI scanning procedure, or claustrophobia; and
  5. a past history of drug addiction or serious psychopathology, other than anxiety or depression.

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): NCT02737436


Contacts
Layout table for location contacts
Contact: Robin` Kochel, PhD 832.824.3390 kochel@bcm.edu

Locations
Layout table for location information
United States, Texas
Children's Nutrition Research Center Recruiting
Houston, Texas, United States, 77030
Contact: Robin Kochel, PhD    832-824-3390    kochel@bcm.edu   
Sponsors and Collaborators
Baylor College of Medicine
University of Iowa
Investigators
Layout table for investigator information
Principal Investigator: Lane Strathearn, MD PhD Baylor College of Medicine

Layout table for additonal information
Responsible Party: Robin Kochel, Associate Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT02737436     History of Changes
Other Study ID Numbers: H-26732
First Posted: April 14, 2016    Key Record Dates
Last Update Posted: December 13, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
Layout table for MeSH terms
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs