- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04604938
The Effects of Losartan on Reward Reinforcement Learning
21. oktober 2020 opdateret af: Benjamin Becker, University of Electronic Science and Technology of China
The Role of the Renin-angiotensin System in Reward Reinforcement Learning
This study aims to investigate whether a single dose of losartan (50 mg) can affect learning from positive and negative outcomes and its related neural mechanisms.
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Emerging evidence suggests that the renin-angiotensin system can impact dopamine (DA) transmission and its modulatory role in reward processing.
For instance, recent animal models have found that the angiotensin antagonist losartan reduces rewarding effects of methamphetamine and nicotine by modulating DA release in the striatum.The present study thus will investigate losartan effects on reward reinforcement learning and the underlying neural mechanisms.
In a double-blind, between-subject, placebo-controlled design, 60 healthy male subjects will be randomly assigned to receive single-dose losartan (50 mg) or placebo, 90 minutes before performing a probabilistic reinforcement learning task during fMRI.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
60
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:
- Weihua Zhao, PhD
- E-mail: zarazhao.uestc@outlook.com
-
-
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
Han
Beskrivelse
Inclusion Criteria:
- Healthy subjects without past or current psychiatric or neurological disorders
- Right-handedness
- Normal or corrected-normal version
Exclusion Criteria:
- History of head injury
- Medical or psychiatric illness
- Hypertension
- General cardio-vascular alteration or diseases
- Allergy against medications
- Visual or motor impairments
- Claustrophobia
- Drug addiction
- Nicotine dependence
- FMRI contradictions
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:
|
|
Placebo komparator: Placebo gruppe
Lægemiddel: Placebo oral tablet
|
administration of placebo (oral)
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
BOLD-level activity as assessed by fMRI during the learning phase
Tidsramme: 90 minutes to 110 minutes after treatment
|
During the paradigm subjects will learn the reward properties of stimuli via the presentation of trial-wise feedback.
The neural activation during the prediction of positive and negative outcome feedback will be assessed by functional magnetic resonance imaging (fMRI), particularly in prefrontal and subcortical regions.
The effects of treatment will be determined by comparing the losartan- and placebo-treated groups.
|
90 minutes to 110 minutes after treatment
|
|
BOLD-level activity as assessed by fMRI during the learning transfer phase
Tidsramme: 111 minutes to 120 minutes after treatment
|
Following the initial learning phase subjects learning transfer will be examined by asking subjects to choose between stimuli with high versus low reward probabilities.
The neural activation during correct responses will be assessed by functional magnetic resonance imaging (fMRI), particularly in prefrontal and subcortical regions.
The effects of treatment will be determined by comparing the losartan- and placebo-treated groups.
|
111 minutes to 120 minutes after treatment
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Choice accuracy for the stimulus with the high reward probability during the learning phase
Tidsramme: 90 minutes to 110 minutes after treatment
|
During the learning phase accuracies (in percent) for choosing the stimulus with the highest reward probability will be computed.
Effects of treatment on choice accuracy in the probabilistic learning task will be examined by comparing accuracies (percent) between the losartan- and placebo-treated group.
|
90 minutes to 110 minutes after treatment
|
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Learning rate for positive and negative outcomes
Tidsramme: 90 minutes to 110 minutes after treatment
|
The learning rate will be determined by performing computational modelling.
The learning rate index for positive and negative outcomes during the learning phase will be compared between the losartan- and placebo-treated group.
|
90 minutes to 110 minutes after treatment
|
|
Choice accuracy during the learning transfer phase
Tidsramme: 111 minutes to 120 minutes after treatment
|
Following the initial learning phase subjects learning transfer will be examined by asking subjects to choose between stimuli with high versus low reward probabilities.
For the transfer phase the choice accuracy for selecting stimuli with the highest reward probability and avoiding stimuli with the lowest reward probability will be computed.
The effects of treatment will be determined by comparing the accuracy between the losartan- and placebo-treated groups.
|
111 minutes to 120 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
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- UESTC-neuSCAN-75
Plan for individuelle deltagerdata (IPD)
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