Neurobiological Bases of Paternal Nurturance

NCT02223429 | Completed Results DMC

• 2 other identifiers: IRB00044782R21HD078778
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 2

Brief Summary

The overall goal of this project is to identify the genetic, hormonal, and neurobiological influences on paternal nurturing behavior and to determine if fathers' neural responses to infants can be modulated by neuropeptides known to play a role in parenting in experimental animal models. The aim is to determine if pharmacological manipulation of central oxytocin (OT) and vasopressin (AVP) levels influences the neural response to viewing pictures of one's own infant or to hearing cry stimuli. In a double-blind procedure, fathers with 1-3 year old children will be scanned on two separate occasions; once under the influence of OT/AVP and once under the influence of placebo. Fathers will be randomized to either OT or AVP, and order of administration of drug and placebo will counterbalanced across subjects. Fathers will be scanned while viewing pictures of their own and an unknown child and while listening to unknown infant cry stimuli. The investigators hypothesize:

• OT will augment the ventral tegmental area (VTA), ventral striatum and medial orbitofrontal cortex (mOFC) response to viewing pictures of one's own child, and will augment the primary auditory cortex (AI) response of fathers to infant cries.
• AVP will augment the lateral septum response to viewing own child pictures.

Conditions

Healthy

Keywords

Paternal nurturance; Oxytocin; Vasopressin; fMRI; Neurobiology

Outcome Measures

Primary Outcomes (6)

• Mean Percent Signal Change in Ventral Tegmental Area (VTA)

  The effect of the drug will be assessed by determining changes in brain activation to own child pictures versus adult pictures (O-A) between OT treatment and placebo treatments (OT-PL) from functional magnetic resonance imaging (fMRI). Changes will be assessed in the OT group only per protocol.

  Baseline, Visit 2 (Up to 10 days)

• Mean Percent Signal Change in Right Ventral Striatum

  The effect of the drug will be assessed by determining changes in brain activation to own child pictures versus adult pictures (O-A) between OT treatment and placebo treatments (OT-PL) from functional magnetic resonance imaging (fMRI). Changes will be assessed in the OT group only per protocol.

  Baseline, Visit 2 (Up to 10 days)

• Mean Percent Signal Change in Right Medial Orbitofrontal Cortex

  The effect of the drug will be assessed by determining changes in brain activation to own child pictures versus adult pictures (O-A) between OT treatment and placebo treatments (OT-PL) from functional magnetic resonance imaging (fMRI). Changes will be assessed in the OT group only per protocol.

  Baseline, Visit 2 (Up to 10 days)

• Mean Percent Signal Change in Caudate Nucleus

  The effect of the drug will be assessed by determining changes in brain activation to own child pictures versus adult pictures (O-A) between OT treatment and placebo treatments (OT-PL) from functional magnetic resonance imaging (fMRI).

  Baseline, Visit 2 (Up to 10 days)

• Mean Percent Signal Change in the Visual Cortex

  The effect of the drug will be assessed by determining changes in brain activation to own child pictures versus adult pictures (O-A) between OT treatment and placebo treatments (OT-PL) from functional magnetic resonance imaging (fMRI).

  Baseline, Visit 2 (Up to 10 days)

• Mean Percent Signal Change in the Anterior Cingulate Cortex

  The effect of the drug will be assessed by determining changes in brain activation to own child pictures versus adult pictures (O-A) between OT treatment and placebo treatments (OT-PL) from functional magnetic resonance imaging (fMRI).

  Baseline, Visit 2 (Up to 10 days)

Secondary Outcomes (6)

• Change in Plasma Levels of Vasopressin (AVP)

  Baseline, Visit 2 (Up to 10 days)

• Change in Plasma Levels of Oxytocin (OT)

  Baseline, Visit 2 (Up to 10 days)

• Difference in Cry Rating Scores Between OT and Placebo

  Baseline, Visit 2 (Up to 10 days)

• Difference in Cry Rating Scores Between AVP and Placebo

  Baseline, Visit 2 (Up to 10 days)

• Mean Percent Signal Change in Primary Auditory Cortex

  Baseline, Visit 2 (Up to 10 days)

Study Arms (2)

OT + placebo

EXPERIMENTAL

The OT + placebo group will self-administer no more than 1 ml solution of oxytocin or placebo in each nostril; five (5) sprays per each nostril, for a total of ten (10) sprays. The order of administration of drug and placebo will counterbalanced across subjects, such that half will receive OT first, and half will receive OT second.

Drug: Oxytocin; Drug: Placebo

AVP + placebo

EXPERIMENTAL

The AVP + placebo group will self-administer no more than 1 ml solution of vasopressin or placebo in each nostril; five (5) sprays per each nostril, for a total of ten (10) sprays. The order of administration of drug and placebo will counterbalanced across subjects, such that half will receive AVP first, and half will receive AVP second.

Drug: Vasopressin; Drug: Placebo

Interventions

Oxytocin DRUG

1 ml solution in each nostril; five (5) sprays per each nostril, for a total of ten (10) sprays

Also known as: Pitocin, Syntocinon, OT

OT + placebo

Vasopressin DRUG

1 ml solution in each nostril; five (5) sprays per each nostril, for a total of ten (10) sprays

Also known as: Argipressin, Arginine vasopressin (AVP), Antidiuretic hormone (ADH)

AVP + placebo

Placebo DRUG

1 ml solution in each nostril; five (5) sprays per each nostril, for a total of ten (10) sprays

AVP + placebo; OT + placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• above 18
• biological fathers of 1-3 year old infants who are currently cohabitating with the child's mother
• normal or corrected-to-normal vision of 20/40

You may not qualify if:

• current or past history of mental illness
• active medical or neurological disorder
• current or past history of alcohol or drug dependence
• claustrophobic (at the discretion of the PI with subject consultation)
• history of seizures or other neurological disorder
• history of hypertension, cardiovascular disease, nephritis, diabetes or other endocrine diseases or malignancy
• ferrous metal in any part of the body
• history of asthma or migraine headaches (can be included at the discretion of the study physician or nurse practitioner if episodes are infrequent and no active problems at time of study, not medicated)

Sponsors & Collaborators

• James K. Rilling, PhD: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (2)

Emory University Hospital

Atlanta, Georgia, 30307, United States

Location

Emory University 1462 Clifton Rd

Atlanta, Georgia, 30322, United States

Location

Related Publications (1)

• Hamann S, Herman RA, Nolan CL, Wallen K. Men and women differ in amygdala response to visual sexual stimuli. Nat Neurosci. 2004 Apr;7(4):411-6. doi: 10.1038/nn1208. Epub 2004 Mar 7.

  PMID: 15004563 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Diabetes Insipidus

Interventions

Oxytocin; Vasopressins; Arginine Vasopressin

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pituitary Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Neuropeptides; Oligopeptides; Nerve Tissue Proteins; Proteins

Limitations and Caveats

Plasma levels of vasopressin (AVP) and peripheral levels of oxytocin (OT) were not assayed due to lack of funding.

Results Point of Contact

• Title: Dr. James Rilling
• Organization: Emory University

jrillin@emory.edu

404-727-3062

Study Officials

• James K Rilling, Ph.D.

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 20, 2014
• First Posted: August 22, 2014
• Study Start: August 1, 2014
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: June 5, 2017
• Results First Posted: June 5, 2017

Record last verified: 2017-04

Locations

US (2)