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Completed

NCT Number: NCT02223429

Neurobiological Bases of Paternal Nurturance

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.

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Key information

Conditions

Healthy Diabetes Insipidus Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pituitary Diseases Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emory University 1462 Clifton Rd, Atlanta, Georgia, United States

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About this study

30 fathers of children aged 1-3 will participate in two functional imaging sequence (fMRI) sessions, once under the influence of OT/AVP, and once under the influence of placebo. Fathers will be restricted to men who are living with their biological child and an adult partner (male or female) that they are in a committed relationship with. All fathers will receive two fMRI scans on two different occasions, separated by 2-10 days. 15 fathers will be randomized to intranasal OT, the other 15 will be randomized to intranasal AVP. Within each drug group, the order of administration of drug and placebo will counterbalanced across subjects, such that 15 will receive OT/AVP first, and 15 will receive OT/AVP second. During the fMRI scans, fathers will view pictures of their own and unknown children, as well as unknown adults. Afterwards, while still in the scanner, they will listen to infant cry and control stimuli. After exiting the scanner, fathers will again listen to the cry stimuli and will rate their emotional reaction to the cry stimuli on the following dimensions using a 7 point likert scale: irritated, sympathetic, alarmed, angry, upset, compassionate, distressed, annoyed, and tender.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)
  • history of head trauma or psychiatric illness, as well as those who are receiving or have received over the past year, medication with known psychoactive effects (included at the discretion of the PI as these are exclusion criteria due to data quality concerns and not safety concerns; head trauma should be minimal enough deemed by the PI)

Treatment and study plan

Oxytocin

Drug

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

Other names: Pitocin, Syntocinon, OT

Vasopressin

Drug

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

Other names: Argipressin, Arginine vasopressin (AVP), Antidiuretic hormone (ADH)

Placebo

Drug

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

Primary outcomes

  1. Mean Percent Signal Change in Ventral Tegmental Area (VTA)

    Time frame: Baseline, Visit 2 (Up to 10 days)

    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.

  2. Mean Percent Signal Change in Right Ventral Striatum

    Time frame: Baseline, Visit 2 (Up to 10 days)

    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.

  3. Mean Percent Signal Change in Right Medial Orbitofrontal Cortex

    Time frame: Baseline, Visit 2 (Up to 10 days)

    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.

  4. Mean Percent Signal Change in Caudate Nucleus

    Time frame: Baseline, Visit 2 (Up to 10 days)

    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).

  5. Mean Percent Signal Change in the Visual Cortex

    Time frame: Baseline, Visit 2 (Up to 10 days)

    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).

  6. Mean Percent Signal Change in the Anterior Cingulate Cortex

    Time frame: Baseline, Visit 2 (Up to 10 days)

    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).

Secondary outcomes

  1. Change in Plasma Levels of Vasopressin (AVP)

    Time frame: Baseline, Visit 2 (Up to 10 days)

    Peripheral levels of AVP will be assessed via assay of plasma collected.

  2. Change in Plasma Levels of Oxytocin (OT)

    Time frame: Baseline, Visit 2 (Up to 10 days)

    Peripheral levels of OT will be assessed via assay of plasma collected.

  3. Difference in Cry Rating Scores Between OT and Placebo

    Time frame: Baseline, Visit 2 (Up to 10 days)

    The effect of the drug will be assessed by analyzing the differences between ratings of infant cries under OT and placebo treatment on a 7-point likert scale. Sixteen adjectives will be used to describe two different cries. Participants will rate each cry from 1-7 where one represents "not at all" and 7 represents "extremely". Difference is defined as OT minus placebo scores.

  4. Difference in Cry Rating Scores Between AVP and Placebo

    Time frame: Baseline, Visit 2 (Up to 10 days)

    The effect of the drug will be assessed by analyzing the differences between ratings of infant cries under AVP and placebo treatment on a 7-point likert scale. Sixteen adjectives will be used to describe two different cries. Participants will rate each cry from 1-7 where one represents "not at all" and 7 represents "extremely". Difference is defined as AVP minus placebo scores.

  5. Mean Percent Signal Change in Primary Auditory Cortex

    Time frame: Baseline, Visit 2 (Up to 10 days)

    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.

  6. Mean Percent Signal Change in Right Lateral Septum

    Time frame: Baseline, Visit 2 (Up to 10 days)

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

Sponsors and collaborators

Lead sponsor

James K. Rilling, PhD

Other

Collaborators

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

Registry information

Official study title

Biological Bases of Individual Variation in Paternal Nurturance

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Aug 22, 2014
Registry last updated
Jun 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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