N/A
N=32
Neurobiological Bases of Paternal Nurturance
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT02223429 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcome: Primary: Mean Percent Signal Change in Ventral Tegmental Area (VTA) — 0.54; 0.27 Percent signal change
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Oxytocin (Drug); Vasopressin (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- James K. Rilling, PhD
- Primary completion
- Feb 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Percent Signal Change in Ventral Tegmental Area (VTA) |
0.54; 0.27 | — |
| PRIMARY Mean Percent Signal Change in Right Ventral Striatum |
-1.28; -0.81 | — |
| PRIMARY Mean Percent Signal Change in Right Medial Orbitofrontal Cortex |
-0.22; -0.53 | — |
| PRIMARY Mean Percent Signal Change in Caudate Nucleus |
0.85; -0.27 | — |
| PRIMARY Mean Percent Signal Change in the Visual Cortex |
0.83; 0.10 | — |
| PRIMARY Mean Percent Signal Change in the Anterior Cingulate Cortex |
0.27; -0.39 | — |
| SECONDARY Change in Plasma Levels of Vasopressin (AVP) |
— | — |
| SECONDARY Change in Plasma Levels of Oxytocin (OT) |
— | — |
| SECONDARY Difference in Cry Rating Scores Between OT and Placebo |
3.71; 4.64; 4.29; 4.86; 4.29; 4.36 | — |
| SECONDARY Difference in Cry Rating Scores Between AVP and Placebo |
4.69; 4.06; 5.44; 5.31; 4.81; 4.19 | — |
| SECONDARY Mean Percent Signal Change in Primary Auditory Cortex |
0.10; 0.10 | — |
| SECONDARY Mean Percent Signal Change in Right Lateral Septum |
0.19; 0.36 | — |
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.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT02223429). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.