The Effects of Losartan on Social Reward
21. oktober 2020 oppdatert av: 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
Studieoversikt
Status
Ukjent
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Forventet)
90
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
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Sichuan
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Chengdu, Sichuan, Kina, 611731
- Rekruttering
- University of Electronic Science and Technology of China
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Ta kontakt med:
- Weihua Zhao, PhD
- E-post: zarazhao.uestc@outlook.com
-
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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 30 år (Voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
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
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: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Losartan-gruppen
Legemiddel: Losartan
|
administration of losartan (50 mg) (oral)
Andre navn:
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Placebo komparator: Placebo gruppe
Legemiddel: Placebo oral tablett
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administrering av placebo (oral)
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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
|
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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 |
Tiltaksbeskrivelse |
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.
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150 minutes to 160 minutes after treatment
|
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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.
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150 minutes to 160 minutes after treatment
|
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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.
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150 minutes to 160 minutes after treatment
|
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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.
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150 minutes to 160 minutes after treatment
|
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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.
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150 minutes to 160 minutes after treatment
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Benjamin Becker, PhD, University of Electronic Science and Technology of China
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)
10. oktober 2020
Primær fullføring (Forventet)
31. desember 2021
Studiet fullført (Forventet)
31. mars 2022
Datoer for studieregistrering
Først innsendt
9. oktober 2020
Først innsendt som oppfylte QC-kriteriene
21. oktober 2020
Først lagt ut (Faktiske)
27. oktober 2020
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
27. oktober 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
21. oktober 2020
Sist bekreftet
1. oktober 2020
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- UESTC-neuSCAN-72
Plan for individuelle deltakerdata (IPD)
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NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
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Nei
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