Ignite Creation Date:
2024-05-06 @ 3:12 AM
Last Modification Date:
2024-10-26 @ 11:29 AM
Study NCT ID:
NCT02223429
Status:
COMPLETED
Last Update Posted:
2017-06-05
First Post:
2014-08-20
Brief Title:
Neurobiological Bases of Paternal Nurturance
Sponsor:
James K Rilling PhD
Organization:
Emory University
Study Overview
Official Title:
Biological Bases of Individual Variation in Paternal Nurturance
Status:
COMPLETED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ones 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 OTAVP 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 ones 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
The aim is to determine if pharmacological manipulation of central oxytocin OT and vasopressin AVP levels influences the neural response to viewing pictures of ones 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 OTAVP 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 ones 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
Detailed Description:
30 fathers of children aged 1-3 will participate in two functional imaging sequence fMRI sessions once under the influence of OTAVP 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 OTAVP first and 15 will receive OTAVP 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R21HD078778 | NIH | None | httpsreporternihgovquickSearchR21HD078778 |