The Effects of Losartan on Emotion Processing

Sponsor

University of Electronic Science and Technology of China (Other)

Overall Status

Recruiting

CT.gov ID

NCT04606212

Collaborator

(none)

Enrollment

Location

Arms

17.6

Anticipated Duration (Months)

5.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Losartan Drug: Placebo Oral Tablet	N/A

Detailed 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.

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 Emotion Processing 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 administration of losartan (50 mg) (oral)
Placebo Comparator: Placebo group	Drug: Placebo Oral Tablet administration of placebo (oral)

Arm

Intervention/Treatment

Experimental: Losartan group

Drug: Losartan

administration of losartan (50 mg) (oral)

Placebo Comparator: Placebo group

Drug: Placebo Oral Tablet

administration of placebo (oral)

Outcome Measures

Primary Outcome Measures

Neural activity as measured by BOLD fMRI during processing of emotional and novel stimuli [105 to 145 minutes after treatment administration]
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.

Secondary Outcome Measures

Neural activity as measured by BOLD fMRI during processing of different categories of emotional and novel stimuli [105 to 145 minutes after treatment administration]
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.
Accuracy for target oddballs [105 to 145 minutes after treatment administration]
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.
Reaction times for target oddballs [105 to 145 minutes after treatment administration]
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.

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:

NCT04606212

Other Study ID Numbers:

UESTC-neuSCAN-73

First Posted:

Oct 28, 2020

Last Update Posted:

Oct 28, 2020

Last Verified:

Oct 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Benjamin Becker, Professor, University of Electronic Science and Technology of China

Losartan

emotion processing

Additional relevant MeSH terms:

Losartan

Study Results

No Results Posted as of Oct 28, 2020