- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03265899
Oxytocin and the Processing of Social Stress-Associated Chemosignals
25. august 2017 opdateret af: Rene Hurlemann, University Hospital, Bonn
Double-blind, Placebo-controlled, Randomized Study: Oxytocin Modulation of Stress-Associated Chemosignals Processing
The purpose of this study is to determine whether oxytocin modulates the processing of stress-associated chemosignals and which substrates are involved.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Social transmission of stress and fear is not restricted to visual or auditory cues, but extends to the olfactory domain, a phylogenetically more ancient sense.
Exposure to axillary sweat from healthy volunteers undergoing an emotional stressor task evokes a strong vicarious stress response on the behavioral and neural level.Particularly, anxious individuals have been shown to exhibit a heightened sensitivity to social chemosensory stress cues (axillary sweat).
The neuropeptide oxytocin (OXT) exerts anxiolytic and anti-stress effects in visual and auditory modalities, however, it still elusive whether OXT also modulates the processing of stress-associated chemosignals.
Axillary sweat were obtained from an unrelated sample of 30 healthy men undergoing the Trier Social Stress Test and ergometer training as control.Subsequently, subjects completed a forced-choice emotional face recognition task composed of stimuli with varying intensities (neutral to fearful), while they were exposed to both sweat stimuli and a non-social control odor (raspberry) after OXT or placebo administration, respectively.
The investigators expect that OXT selectively diminishes chemosensory-induced behavioral biases and neural responses to stress-related odors.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
60
Fase
- Fase 1
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 til 40 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Healthy volunteers
- Right-handed
Exclusion Criteria:
- Current or past psychiatric disease
- Current or past physical illness
- Psychoactive medication
- Tobacco smokers
- MRI contraindications (e.g. metal in body, claustrophobia)
- Anosmia
- Medication known to interfere with olfactory processing
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: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Oxytocin
40 IU Oxytocin, intranasal application 30 min prior to the experiment
|
40 IU; 5 puffs balanced across nostrils, at an inter-puff interval of 30 seconds
Andre navne:
|
Placebo komparator: Placebo
sodium chloride solution, intranasal application 30 min prior to the experiment
|
Placebo nasal spray, 5 puffs balanced across nostrils, at an inter-puff interval of 30 seconds
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Forced-choice ratings of morphed emotional faces with varying intensities (neutral to fearful).
Tidsramme: 30 min after nasal spray administration
|
After each trial, subjects were asked to use a button response grip to indicate whether they perceived the depicted face as neutral or fearful.
|
30 min after nasal spray administration
|
Response time for facial stimuli ratings.
Tidsramme: 30 min after nasal spray administration
|
30 min after nasal spray administration
|
|
Blood-oxygen-level dependent signal in response to chemosensory cues.
Tidsramme: 30 minutes after nasal spray administration
|
The modulatory effect of oxytocin on neural correlates Using functional magnetic resonance imaging, signal changes in the amygdala, hippocampus and the anterior cingulate cortex in response to olfactory cues of stress and sport (axillary sweat obtained from an unrelated sample of 30 healthy men undergoing the Trier Social Stress Test and ergometer training as control).
|
30 minutes after nasal spray administration
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Questionnaire measurement of mood (PANAS).
Tidsramme: 15 minutes before the nasal spray administration and (on average) 10 minutes after the fMRI experiment
|
15 minutes before the nasal spray administration and (on average) 10 minutes after the fMRI experiment
|
Saliva oxytocin concentrations
Tidsramme: immediately before the nasal spray administration and (on average) 10 minutes after the fMRI experiment
|
immediately before the nasal spray administration and (on average) 10 minutes after the fMRI experiment
|
Questionnaire measurement of anxiety (STAI).
Tidsramme: 15 minutes after nasal spray administration and (on average) 10 minutes after the fMRI experiment
|
15 minutes after nasal spray administration and (on average) 10 minutes after the fMRI experiment
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Rene Hurlemann, MSc MD PhD, Department of Psychiatry, University of Bonn, Germany
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 (Faktiske)
1. juli 2015
Primær færdiggørelse (Faktiske)
30. november 2016
Studieafslutning (Faktiske)
30. november 2016
Datoer for studieregistrering
Først indsendt
18. august 2017
Først indsendt, der opfyldte QC-kriterier
25. august 2017
Først opslået (Faktiske)
29. august 2017
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
29. august 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
25. august 2017
Sidst verificeret
1. august 2017
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- OXT_OLF_2017
Plan for individuelle deltagerdata (IPD)
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