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The Effects of Losartan on Social Reward

21. oktober 2020 opdateret af: Benjamin Becker, University of Electronic Science and Technology of China

Losartan Effects on the Social Reward in Humans

The aim of the study is to investigate the effect of losartan (50mg, single dose) on social reward

Studieoversigt

Status

Ukendt

Betingelser

Detaljeret beskrivelse

In a double-blind, between-subject, placebo-controlled design the effects of a single dose of losartan (50mg) on social reward in healthy participants will be examined. 90 minutes after subjects administrate 50mg losartan or placebo, participants will undergo a social incentive delay task. Neural activity will be assessed by the acquisition of functional magnetic resonance imaging (fMRI) data.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

90

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

    • Sichuan
      • Chengdu, Sichuan, Kina, 611731
        • Rekruttering
        • University of Electronic Science and Technology of China
        • Kontakt:

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 30 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Healthy subjects without past or current psychiatric or neurological disorders

Exclusion Criteria:

  • history of head injury
  • medical or psychiatric illness
  • hypertension

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: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Losartan gruppe
Lægemiddel: Losartan
administration of losartan (50 mg) (oral)
Andre navne:
  • Cozaar Oral Tablet
Placebo komparator: Placebo gruppe
Lægemiddel: Placebo oral tablet
administration af placebo (oral)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Losartan effects on neural activity as assessed by blood oxygenation dependent (BOLD) fMRI during the anticipation of social feedback.
Tidsramme: 90 minutes to 105 minutes after treatment
The social incentive delay task provides subjects with trial-wise feedback on their performance (as assessed by reaction time). Neural activity will be measured by functional magnetic resonance imaging (fMRI). To examine effects of treatment during the anticipation of social feedback fMRI-based neural indices during the anticipation period will be compared between the losartan and the placebo treated group using a Generalized Linear Model approach. The analysis will focus on brain systems that play an important role in the anticipation of reward and punishment (prefrontal cortex and subcortical regions, including the striatum)
90 minutes to 105 minutes after treatment
Losartan effects on neural activity as assessed by blood oxygenation dependent (BOLD) fMRI during the consummation of social feedback.
Tidsramme: 90 minutes to 105 minutes after treatment
The social incentive delay task provides subjects with trial-wise feedback on their performance (as assessed by reaction time). Following each trial the feedback will be indicated by positive and negative social stimuli. Neural activity will be measured by functional magnetic resonance imaging (fMRI). To examine effects of treatment during the consummation of social feedback fMRI-based neural indices during the presentation of the feedback will be compared between the losartan and the placebo treated group using a Generalized Linear Model approach. The analysis will focus on brain systems that play an important role in reward and punishment (prefrontal cortex and subcortical regions, including the striatum)
90 minutes to 105 minutes after treatment

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Effects of Losartan on arousal ratings of the stimuli presented during the fMRI-paradigm as assessed by 1-9 Likert scales
Tidsramme: 150 minutes to 160 minutes after treatment
Following the fMRI assessment participants will be asked to rate the arousal of the stimuli presented during fMRI. Arousal will be assessed on 1-9 Likert rating scales. To examine effects of treatment on arousal ratings the losartan and placebo groups will be compared using Generalized Linear Model approach.
150 minutes to 160 minutes after treatment
Effects of Losartan on valence ratings of the stimuli presented during the fMRI-paradigm as assessed by 1-9 Likert scales
Tidsramme: 150 minutes to 160 minutes after treatment
Following the fMRI assessment participants will be asked to rate the valence of the stimuli presented during fMRI. Valence will be assessed on 1-9 Likert rating scales. To examine effects of treatment on valence ratings the losartan and placebo groups will be compared using Generalized Linear Model approach.
150 minutes to 160 minutes after treatment
Effects of Losartan on intensity ratings of the stimuli presented during the fMRI-paradigm as assessed by 1-9 Likert scales
Tidsramme: 150 minutes to 160 minutes after treatment
Following the fMRI assessment participants will be asked to rate the intensity of the stimuli presented during fMRI. Intensity will be assessed on 1-9 Likert rating scales. To examine effects of treatment on intensity ratings the losartan and placebo groups will be compared using Generalized Linear Model approach.
150 minutes to 160 minutes after treatment
Effects of Losartan on likeability ratings of the stimuli presented during the fMRI-paradigm as assessed by 1-9 Likert scales
Tidsramme: 150 minutes to 160 minutes after treatment
Following the fMRI assessment participants will be asked to rate the likeability of the stimuli presented during fMRI. Likeability will be assessed on 1-9 Likert rating scales. To examine effects of treatment on likeability ratings the losartan and placebo groups will be compared using Generalized Linear Model approach.
150 minutes to 160 minutes after treatment
Effects of Losartan on dislikeability ratings of the stimuli presented during the fMRI-paradigm as assessed by 1-9 Likert scales
Tidsramme: 150 minutes to 160 minutes after treatment
Following the fMRI assessment participants will be asked to rate the dislikeability of the stimuli presented during fMRI. Dislikeability will be assessed on 1-9 Likert rating scales. To examine effects of treatment on dislikeability ratings the losartan and placebo groups will be compared using Generalized Linear Model approach.
150 minutes to 160 minutes after treatment

Samarbejdspartnere og efterforskere

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

Efterforskere

  • Ledende efterforsker: Benjamin Becker, PhD, University of Electronic Science and Technology of China

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)

10. oktober 2020

Primær færdiggørelse (Forventet)

31. december 2021

Studieafslutning (Forventet)

31. marts 2022

Datoer for studieregistrering

Først indsendt

9. oktober 2020

Først indsendt, der opfyldte QC-kriterier

21. oktober 2020

Først opslået (Faktiske)

27. oktober 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

27. oktober 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. oktober 2020

Sidst verificeret

1. oktober 2020

Mere information

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Kliniske forsøg med Placebo oral tablet

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