NCT04606212

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Oct 2020

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 9, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

October 10, 2020

Completed
18 days until next milestone

First Posted

Study publicly available on registry

October 28, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
Last Updated

October 28, 2020

Status Verified

October 1, 2020

Enrollment Period

1.2 years

First QC Date

October 9, 2020

Last Update Submit

October 21, 2020

Conditions

Keywords

Losartanemotion processing

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Neural activity as measured by BOLD fMRI during processing of different categories of emotional and novel stimuli

    105 to 145 minutes after treatment administration

  • Accuracy for target oddballs

    105 to 145 minutes after treatment administration

  • Reaction times for target oddballs

    105 to 145 minutes after treatment administration

Study Arms (2)

Losartan group

EXPERIMENTAL
Drug: Losartan

Placebo group

PLACEBO COMPARATOR
Drug: Placebo Oral Tablet

Interventions

administration of losartan (50 mg) (oral)

Losartan group

administration of placebo (oral)

Placebo group

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy subjects without past or current psychiatric or neurological disorders

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Electronic Science and Technology of China

Chengdu, Sichuan, 611731, China

RECRUITING

MeSH Terms

Interventions

Losartan

Intervention Hierarchy (Ancestors)

Biphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTetrazoles

Study Officials

  • Benjamin Becker, PhD

    University of Electronic Science and Technology of China

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 9, 2020

First Posted

October 28, 2020

Study Start

October 10, 2020

Primary Completion

December 31, 2021

Study Completion

March 31, 2022

Last Updated

October 28, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations