The Effects of Losartan on Social Reward

Healthy Clinical Trial

Official title:

Losartan Effects on the Social Reward in Humans

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04604756
• Other study ID #: UESTC-neuSCAN-72
• Status: Recruiting
• Phase: N/A
• Start date: October 10, 2020
• Est. completion date: March 31, 2022

Study information

• Verified date: October 2020
• Source: University of Electronic Science and Technology of China
• Contact: Weihua Zhao, PhD
• Phone: 86-28-61830811
• Email: zarazhao.uestc[@]outlook.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: March 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

Inclusion Criteria:

• Healthy subjects without past or current psychiatric or neurological disorders

Exclusion Criteria:

• history of head injury

• medical or psychiatric illness

• hypertension

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Losartan
administration of losartan (50 mg) (oral)
• Placebo Oral Tablet
administration of placebo (oral)

Locations

Country	Name	City	State
China	University of Electronic Science and Technology of China	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
University of Electronic Science and Technology of China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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