Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Neurobiological Bases of Paternal Nurturance

27. april 2017 opdateret af: James K. Rilling, PhD

Biological Bases of Individual Variation in 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

35

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30307
        • Emory University Hospital
      • Atlanta, Georgia, Forenede Stater, 30322
        • Emory University 1462 Clifton Rd

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: OT + placebo
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.
Medicin: Oxytocin
1 ml solution in each nostril; five (5) sprays per each nostril, for a total of ten (10) sprays
Andre navne:
  • Pitocin
  • Syntocinon
  • OT
Medicin: Placebo
1 ml solution in each nostril; five (5) sprays per each nostril, for a total of ten (10) sprays
Eksperimentel: AVP + placebo
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.
Medicin: Placebo
1 ml solution in each nostril; five (5) sprays per each nostril, for a total of ten (10) sprays
Medicin: Vasopressin
1 ml solution in each nostril; five (5) sprays per each nostril, for a total of ten (10) sprays
Andre navne:
  • Argipressin
  • Arginine vasopressin (AVP)
  • Antidiuretic hormone (ADH)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mean Percent Signal Change in Ventral Tegmental Area (VTA)
Tidsramme: 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.
Baseline, Visit 2 (Up to 10 days)
Mean Percent Signal Change in Right Ventral Striatum
Tidsramme: 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.
Baseline, Visit 2 (Up to 10 days)
Mean Percent Signal Change in Right Medial Orbitofrontal Cortex
Tidsramme: 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.
Baseline, Visit 2 (Up to 10 days)
Mean Percent Signal Change in Caudate Nucleus
Tidsramme: 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).
Baseline, Visit 2 (Up to 10 days)
Mean Percent Signal Change in the Visual Cortex
Tidsramme: 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).
Baseline, Visit 2 (Up to 10 days)
Mean Percent Signal Change in the Anterior Cingulate Cortex
Tidsramme: 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).
Baseline, Visit 2 (Up to 10 days)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Plasma Levels of Vasopressin (AVP)
Tidsramme: Baseline, Visit 2 (Up to 10 days)
Peripheral levels of AVP will be assessed via assay of plasma collected.
Baseline, Visit 2 (Up to 10 days)
Change in Plasma Levels of Oxytocin (OT)
Tidsramme: Baseline, Visit 2 (Up to 10 days)
Peripheral levels of OT will be assessed via assay of plasma collected.
Baseline, Visit 2 (Up to 10 days)
Difference in Cry Rating Scores Between OT and Placebo
Tidsramme: 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.
Baseline, Visit 2 (Up to 10 days)
Difference in Cry Rating Scores Between AVP and Placebo
Tidsramme: 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.
Baseline, Visit 2 (Up to 10 days)
Mean Percent Signal Change in Primary Auditory Cortex
Tidsramme: 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.
Baseline, Visit 2 (Up to 10 days)
Mean Percent Signal Change in Right Lateral Septum
Tidsramme: 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.
Baseline, Visit 2 (Up to 10 days)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

James K. Rilling, PhD

Samarbejdspartnere

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

Efterforskere

  • Ledende efterforsker: James K Rilling, Ph.D., Emory University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. august 2014

Primær færdiggørelse (Faktiske)

1. februar 2016

Studieafslutning (Faktiske)

1. februar 2016

Datoer for studieregistrering

Først indsendt

20. august 2014

Først indsendt, der opfyldte QC-kriterier

20. august 2014

Først opslået (Skøn)

22. august 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. juni 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. april 2017

Sidst verificeret

1. april 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IRB00044782
  • R21HD078778 (U.S. NIH-bevilling/kontrakt)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Oxytocin

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Iran

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner