The Effects of Losartan on Social Reward

Sponsor
University of Electronic Science and Technology of China (Other)
Overall Status
Recruiting
CT.gov ID
NCT04604756
Collaborator
(none)
90
1
2
17.6
5.1

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Basic Science
Official Title:
Losartan Effects on the Social Reward in Humans
Actual Study Start Date :
Oct 10, 2020
Anticipated Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
Mar 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Losartan group

Drug: Losartan

Drug: Losartan
administration of losartan (50 mg) (oral)
Other Names:
  • Cozaar Oral Tablet
  • Placebo Comparator: Placebo group

    Drug: Placebo Oral Tablet

    Drug: Placebo Oral Tablet
    administration of placebo (oral)

    Outcome Measures

    Primary Outcome Measures

    1. Losartan effects on neural activity as assessed by blood oxygenation dependent (BOLD) fMRI during the anticipation of social feedback. [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)

    2. Losartan effects on neural activity as assessed by blood oxygenation dependent (BOLD) fMRI during the consummation of social feedback. [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)

    Secondary Outcome Measures

    1. Effects of Losartan on arousal ratings of the stimuli presented during the fMRI-paradigm as assessed by 1-9 Likert scales [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.

    2. Effects of Losartan on valence ratings of the stimuli presented during the fMRI-paradigm as assessed by 1-9 Likert scales [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.

    3. Effects of Losartan on intensity ratings of the stimuli presented during the fMRI-paradigm as assessed by 1-9 Likert scales [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.

    4. Effects of Losartan on likeability ratings of the stimuli presented during the fMRI-paradigm as assessed by 1-9 Likert scales [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.

    5. Effects of Losartan on dislikeability ratings of the stimuli presented during the fMRI-paradigm as assessed by 1-9 Likert scales [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 30 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Healthy subjects without past or current psychiatric or neurological disorders
    Exclusion Criteria:
    • history of head injury

    • medical or psychiatric illness

    • hypertension

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Electronic Science and Technology of China Chengdu Sichuan China 611731

    Sponsors and Collaborators

    • University of Electronic Science and Technology of China

    Investigators

    • Principal Investigator: Benjamin Becker, PhD, University of Electronic Science and Technology of China

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Benjamin Becker, Professor, University of Electronic Science and Technology of China
    ClinicalTrials.gov Identifier:
    NCT04604756
    Other Study ID Numbers:
    • UESTC-neuSCAN-72
    First Posted:
    Oct 27, 2020
    Last Update Posted:
    Oct 27, 2020
    Last Verified:
    Oct 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Benjamin Becker, Professor, University of Electronic Science and Technology of China
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 27, 2020