Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Effects of Intranasal Oxytocin and Stress on Belief Updating

22. juli 2018 oppdatert av: ma, yina, Beijing Normal University

Effects of Intranasal Oxytocin and Induced Stress on People's Belief Updating

To investigate the effect of 24IU intranasal oxytocin on belief updating when people in stress or non-stress condition.

Studieoversikt

Status

Fullført

Forhold

Detaljert beskrivelse

In a randomized, double-blind, placebo controlled between-subjects design, healthy male volunteers receive intranasal oxytocin or placebo under stress or non-stress group prior belief updating task.

The Trier Social Stress Test (TSST) was used to induce psychosocial stress - this standardized technique enables a naturalistic exposure to a psychosocially stressful situation. This method consists primarily of a public speaking in second language (English) and a mental arithmetic task performed in front of a panel. Participants were not informed of the tasks prior to their recruitment. At the start of the TSST, they were told to prepare a 5-min speech to an unknown panel on personal suitability for their ideal job; the job description was matched to each participant, taking into consideration his personal aspirations. After the instructions, subjects were given 10 minutes of solitary preparation for this task. Then, they entered the TSST room and were told to start the presentation in front of a panel of two formally-dressed judges (one male and one female) and a conspicuous video camera. Any pause during the speech prompted a reminder from the judges of the remaining time. The interview was followed by 5 minutes of mental arithmetic performed out loud. Subjects were instructed to serially subtract 13 from 1022 as quickly and accurately as possible in front of the panel. If a mistake was made, the subject was told to start over from the beginning. After the mental arithmetic task, the TSST was concluded - subjects were confronted with the psychosocially stressful situation for a total of 10 minutes.

Non-stress groups first underwent a 5-minute session of travel magazine reading with two casually-dressed people (one male and one female), then did as many easy arithmetic questions within 5 minutes on paper. Participants were told that none of their answers would be marked.

All participants completed two sessions of self life event estimations, each with the same set of 40 adverse life events. The subjects were first presented with the events, then were instructed to estimate their likelihood (0-99%) of experiencing each event in the future (first Estimate, E1) and rate their confidence in their estimate. They were then presented with the actual probability of each event occurring to an average person in a similar environment (Feedback, F) and asked to rate their acceptance of the presented feedback. Five minutes after the first session, participants were instructed to perform the same task and provide their second estimate (E2) for the same 40 events in a randomized order and were, again, instructed to rate their confidence in their estimate. This time, however, no feedback was given. This process was repeated for a friend life event estimation session. After the second session, participants were given a surprise memory test for the presented feedback.

Studietype

Intervensjonell

Registrering (Faktiske)

131

Fase

  • Ikke aktuelt

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 40 år (Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Mann

Beskrivelse

Inclusion Criteria:

  • healthy subjects without past or current psychiatric or neurological disorders

Exclusion Criteria:

  • subjects with past or current psychiatric or neurological disorders

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Grunnvitenskap
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Oxytocin
Oxytocin (OXT), a neuropeptide produced in the hypothalamus, is a key modulator of complex socioaffective responses including affiliation, social approach and attachment, stress and anxiety. Subjects receiving an intranasal spray of OXT (24 IU or 40.32 mg; Syntocinon-spray; Novartis, Switzerland) .
administrert intranasalt
Placebo komparator: Placebo
Placebo contains all ingredients except for the peptide in three puffs of 3.99 IU per 6.72mg nostril.
intranasally administrated
Andre navn:
  • Saltvann

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
The updated probability estimation for negative events in the four experimental groups
Tidsramme: 40~125 minutes after drug administration
Using the second estimation value to minus the first estimation value to get the update value, as well as calculating the update value in desirable condition (first estimation < feedback) and undesirable condition (first estimation < feedback). Then investigated the general belief updating (gBU) and optimistic belief updating (using desirableBU-undesirableBU) in the four experimental condition (i.e., oxytocin-stress, oxytocin-nonstress, placebo-stress, placebo-nonstress).
40~125 minutes after drug administration
The salivary cortisol level in four experimental groups
Tidsramme: 40~125 minutes after drug administration
Conducted ANOVA to test salivary cortisol level in the four experimental groups
40~125 minutes after drug administration
The correlation between personality traits and belief updating value in four experimental groups
Tidsramme: 40~125 minutes after drug administration
Conducted correlation analysis to explore which personality traits would modulate the oxytocin effect or stress effect.
40~125 minutes after drug administration

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

27. desember 2016

Primær fullføring (Faktiske)

15. august 2017

Studiet fullført (Faktiske)

30. juni 2018

Datoer for studieregistrering

Først innsendt

2. juli 2018

Først innsendt som oppfylte QC-kriteriene

22. juli 2018

Først lagt ut (Faktiske)

24. juli 2018

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

24. juli 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

22. juli 2018

Sist bekreftet

1. juli 2018

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • OB-OT and stress

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Sunn

Kliniske studier på Oksytocin

3
Abonnere