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Neurobiological Bases of Paternal Nurturance

27. April 2017 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

35

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • Georgia
      • Atlanta, Georgia, Vereinigte Staaten, 30307
        • Emory University Hospital
      • Atlanta, Georgia, Vereinigte Staaten, 30322
        • Emory University 1462 Clifton Rd

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Alle

Beschreibung

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)

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Grundlegende Wissenschaft
  • Zuteilung: Zufällig
  • Interventionsmodell: Crossover-Aufgabe
  • Maskierung: Verdreifachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Arzneimittel: Oxytocin
1 ml solution in each nostril; five (5) sprays per each nostril, for a total of ten (10) sprays
Andere Namen:
  • Pitocin
  • Syntocinon
  • OT
Arzneimittel: Placebo
1 ml solution in each nostril; five (5) sprays per each nostril, for a total of ten (10) sprays
Experimental: 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.
Arzneimittel: Placebo
1 ml solution in each nostril; five (5) sprays per each nostril, for a total of ten (10) sprays
Arzneimittel: Vasopressin
1 ml solution in each nostril; five (5) sprays per each nostril, for a total of ten (10) sprays
Andere Namen:
  • Argipressin
  • Arginine vasopressin (AVP)
  • Antidiuretic hormone (ADH)

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Mean Percent Signal Change in Ventral Tegmental Area (VTA)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Plasma Levels of Vasopressin (AVP)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

James K. Rilling, PhD

Mitarbeiter

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

Ermittler

  • Hauptermittler: James K Rilling, Ph.D., Emory University

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. August 2014

Primärer Abschluss (Tatsächlich)

1. Februar 2016

Studienabschluss (Tatsächlich)

1. Februar 2016

Studienanmeldedaten

Zuerst eingereicht

20. August 2014

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

20. August 2014

Zuerst gepostet (Schätzen)

22. August 2014

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

5. Juni 2017

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

27. April 2017

Zuletzt verifiziert

1. April 2017

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • IRB00044782
  • R21HD078778 (US NIH Stipendium/Vertrag)

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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