The Effects of Losartan on Emotion Processing

Healthy Clinical Trial

Official title:

Losartan Effects on the Emotion Processing in Humans

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04606212
• Other study ID #: UESTC-neuSCAN-73
• 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 salience processing

Description:

In a double-blind, between-subject, placebo-controlled design the effects of a single dose of losartan (50mg) on salience processing in healthy participants will be examined. The study will adopt a previously validated visual Oddball fMRI paradigm, starting 90 minutes after subjects receive 50mg losartan or placebo. The task requires participants to respond to emotional and novelty oddballs. 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	Neural activity as measured by BOLD fMRI during processing of emotional and novel stimuli	During the oddball paradigm a series of pictures will be presented in rapid succession. Some of the stimuli are oddballs, with respect to emotional content (highly threatening stimuli) or novelty (novel stimuli). Neural activity will be measured by functional magnetic resonance imaging (fMRI). The fMRI data will be examined using a Generalized Linear Model approach. The analysis will examine neural activity in terms of the blood oxygenation dependent (BOLD) response towards threatening and novel oddballs. Effects of treatment on the BOLD response towards threatening and novel oddballs will be examined by comparing the losartan- and placebo-treated subjects.	105 to 145 minutes after treatment administration
Secondary	Neural activity as measured by BOLD fMRI during processing of different categories of emotional and novel stimuli	The oddball paradigm will include different stimulus categories (animal pictures and human faces). Each category will include oddballs, with respect to emotional content (highly threatening stimuli) or novelty (novel stimuli). Neural activity will be measured by functional magnetic resonance imaging (fMRI). The fMRI data will be examined using a Generalized Linear Model approach. The analysis will examine neural activity differences between the stimulus categories (animal pictures, human face pictures) in terms of the blood oxygenation dependent (BOLD) response. Effects of treatment on the BOLD response towards different stimulus categories will be examined by comparing the losartan- and placebo-treated subjects.	105 to 145 minutes after treatment administration
Secondary	Accuracy for target oddballs	Before the paradigm two stimuli will be designated as 'target' and subjects are required to respond by button press to this target. The accuracy for target detection will be computed. Effects of treatment will be examined by comparing the losartan- and placebo-treated subjects.	105 to 145 minutes after treatment administration
Secondary	Reaction times for target oddballs	Before the paradigm two stimuli will be designated as 'target' and subjects are required to respond by button press to this target. The reaction times for correctly identified targets will be computed. Effects of treatment will be examined by comparing reaction times between the losartan- and placebo-treated subjects.	105 to 145 minutes after treatment administration