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Effects of Oxytocin Dose Frequency on Behavioral and Neural Responses

26 ottobre 2018 aggiornato da: Keith Kendrick, University of Electronic Science and Technology of China

Effects of Oxytocin Dose Frequency on Behavioral and Neural Responses, and Modulation by Trait Autism and Genotype

The main aim of the study is to examine effects of different dose frequencies of repeated oxytocin administration on neural and behavioral markers of oxytocin in healthy male subjects. In addition modulatory effects of autism traits and oxytocin receptor genotype (OXTR) will be explored.

Panoramica dello studio

Stato

Sconosciuto

Condizioni

Intervento / Trattamento

Descrizione dettagliata

In the present study, healthy male subjects will be screened according to the study inclusion criteria. After enrollment buccal swaps will be collected for genotyping and subjects will be randomly assigned to three experimental groups that will receive treatment for 5 subsequent days: (1) placebo for five days, (2) oxytocin on days 1, 3 and 5, or (3) oxytocin for five days. Behavioral measures, task-based and resting fMRI will be assessed after the first treatment (acute effects) and the last treatment (chronic effects). The task-based fMRI will employ an implicit emotional face processing paradigm and ratings of the facial emotions will be collected after the fMRI.

Moreover, to control for potential confounding effects of relevant traits all participants will complete the following questionnaires: Interpersonal Reactivity Index (IRI),Beck depression inventory (BDI), State-Trait Anxiety Inventory (STAI). To explore potential modulatory effects of trait autism, all subjects will be administered the Autism Spectrum Quotient (ASQ) scale to assess pre-treatment autism traits.

Tipo di studio

Interventistico

Iscrizione (Anticipato)

150

Fase

  • Fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Cina
    • Sichuan
      • Chengdu, Sichuan, Cina, 610054
        • Reclutamento
        • School of Life Science and Technology, University of Electronic Science and Technology of China

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 17 anni a 30 anni (Bambino, Adulto)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Maschio

Descrizione

Inclusion Criteria:

  • healthy adult males

Exclusion Criteria:

  • past or current psychiatric or neurological disorder head trauma substance abuse medication fMRI contraindications (e.g. metal implants)

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Scienza basilare
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Oxytocin nasal spray(5 doses)
Oxytocin nasal spray for 5 days, 24 IU per day
Droga: Nasal Sprays
Intranasal administration of 24 international units per dose.
Sperimentale: Oxytocin nasal spray(3 doses)
Oxytocin nasal spray or placebo nasal spray interleaved during the 5 days( on the 1st,3rd and 5th day),24 IU per day.
Droga: Nasal Sprays
Intranasal administration of 24 international units per dose.
Comparatore placebo: Placebo nasal spray(control group)
Placebo nasal spray for 5 days,24 IU per day.
Droga: Nasal Sprays
Intranasal administration of 24 international units per dose.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Between group differences in the changes between acute and chronic administration effects of oxytocin on amygdala reactivity towards fearful faces as assessed by fMRI.
Lasso di tempo: 45 minutes after treatment (day 1 vs day 5)
Differences between the treatment groups will be determined by examining differential changes of acute treatment (day 1) vs chronic treatment (day 5) on amygdala activity towards fearful faces. Amygdala activity will be assessed using task-based BOLD fMRI analyses.
45 minutes after treatment (day 1 vs day 5)
Between group differences in the changes between acute and chronic administration effects of oxytocin on amygdala resting state connectivity as assessed by fMRI.
Lasso di tempo: 45 minutes after treatment (day 1 vs day 5)
Differences between the treatment groups will be determined by examining differential changes of acute treatment (day 1) vs chronic treatment (day 5) on amygdala resting state fMRI connectivity. Amygdala functional connectivity will be examined using a seed to whole brain approach.
45 minutes after treatment (day 1 vs day 5)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Association between trait autism with acute and chronic treatment effects on amygdala activity in response to fearful faces
Lasso di tempo: 45 minutes after treatment (day 1 vs day 5)
Associations between autism traits and amygdala response to fearful faces during acute effects (single dose, day 1) and chronic effects (over the course of 5 days) will be examined by means of correlation analyses. Pre-treatment autism trait scores will be assessed using the Autism Spectrum Quotient (ASQ)
45 minutes after treatment (day 1 vs day 5)
Association between trait autism with acute and chronic treatment effects on amygdala resting state connectivity
Lasso di tempo: 45 minutes after treatment (day 1 vs day 5)
Associations between autism traits and amygdala resting state connectivity during acute effects (single dose, day 1) and chronic effects (over the course of 5 days) will be examined by means of correlation analyses. Pre-treatment autism trait scores will be assessed using the Autism Spectrum Quotient (ASQ)
45 minutes after treatment (day 1 vs day 5)
Interaction of acute and chronic treatment effects on amygdala activity with oxytocin receptor genotype.
Lasso di tempo: 45 minutes after treatment (day 1 vs day 5)
Participants will be divided in sub-groups according to their oxytocin receptor (OXTR) genetic profile. Modulatory effects of the OXTR on acute and chronic effects will be explored by comparing effects of treatment on amygdala activity in response to fearful faces as assessed by fMRI between the genotype groups.
45 minutes after treatment (day 1 vs day 5)
Interaction of acute and chronic treatment effects on amygdala connectivity with oxytocin receptor genotype.
Lasso di tempo: 45 minutes after treatment (day 1 vs day 5)
Participants will be divided in sub-groups according to their oxytocin receptor (OXTR) genetic profile. Modulatory effects of the OXTR on acute and chronic effects will be explored by comparing effects of treatment on amygdala resting state connectivity as assessed by fMRI between the genotype groups.
45 minutes after treatment (day 1 vs day 5)
Treatment effects on arousal will be assessed by subjects rating their arousal on a 9-point Likert scale in response to the face pictures presented again after their fMRI scans on day 1 and day 5
Lasso di tempo: 45 minutes after treatment (day 1 vs day 5)
After assessment of the implicit fMRI emotional face paradigm participants will rate the emotional arousal of the stimuli using Likert scales (9 point). Acute and chronic effects will be assessed using repeated measures ANOVAs (day 1 vs day 5) to compare differential changes between the groups.
45 minutes after treatment (day 1 vs day 5)
Treatment effects on valence will be assessed by subjects rating their valence on a 9 point Likert scale in response to the face pictures presented again after their fMRI scans on day 1 and day 5
Lasso di tempo: 45 minutes after treatment (day 1 vs day 5)
After assessment of the implicit fMRI emotional face paradigm participants will rate the emotional valence of the stimuli using Likert scales (9 point). Acute and chronic effects will be assessed using repeated measures ANOVAs (day 1 vs day 5) to compare differential changes between the groups.
45 minutes after treatment (day 1 vs day 5)
Treatment effects on intensity will be assessed by subjects rating their intensity on a 9 point Likert scale in response to the face pictures presented again after their fMRI scans on day 1 and day 5
Lasso di tempo: 45 minutes after treatment (day 1 vs day 5)
After assessment of the implicit fMRI emotional face paradigm participants will rate the emotional intensity of the stimuli using Likert scales (9 point). Acute and chronic effects will be assessed using repeated measures ANOVAs (day 1 vs day 5) to compare differential changes between the groups.
45 minutes after treatment (day 1 vs day 5)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Electronic Science and Technology of China

Investigatori

  • Investigatore principale: Keith Kendrick, PhD, University of Electronic Science and Technology of China

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 marzo 2018

Completamento primario (Effettivo)

1 settembre 2018

Completamento dello studio (Anticipato)

1 dicembre 2018

Date di iscrizione allo studio

Primo inviato

16 luglio 2018

Primo inviato che soddisfa i criteri di controllo qualità

25 luglio 2018

Primo Inserito (Effettivo)

1 agosto 2018

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

29 ottobre 2018

Ultimo aggiornamento inviato che soddisfa i criteri QC

26 ottobre 2018

Ultimo verificato

1 ottobre 2018

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • UESTC-neuSCAN-57

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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