The Effects of Losartan on Social Reward

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

Study Overview

• Status: Unknown
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo Oral Tablet; Drug: Losartan

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 Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 611731
      • Recruiting
      • University of Electronic Science and Technology of China
      • Contact: Weihua Zhao, PhD; Email: zarazhao.uestc@outlook.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy subjects without past or current psychiatric or neurological disorders

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Losartan effects on neural activity as assessed by blood oxygenation dependent (BOLD) fMRI during the anticipation of social feedback.	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.	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effects of Losartan on arousal ratings of the stimuli presented during the fMRI-paradigm as assessed by 1-9 Likert scales	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	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	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	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	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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2020
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): March 31, 2022

Study Registration Dates

• First Submitted: October 9, 2020
• First Submitted That Met QC Criteria: October 21, 2020
• First Posted (Actual): October 27, 2020

Study Record Updates

• Last Update Posted (Actual): October 27, 2020
• Last Update Submitted That Met QC Criteria: October 21, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Losartan; Social reward
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Losartan
• Other Study ID Numbers: UESTC-neuSCAN-72

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No