NCT04606225

Brief Summary

The purpose of this study is to investigate whether a single dose of losartan (50 mg) can affect emotion-memory interaction in healthy humans and its underlying neural mechanisms.

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
60

participants targeted

Target at P50-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

Healthy

Keywords

LosartanEmotion-memory interaction

Outcome Measures

Primary Outcomes (2)

  • fMRI-based indices of neural activity during processing of emotional stimuli will be compared between the treatment groups

    Neural activation during processing of emotional pictures will be assessed by functional magnetic resonance imaging (fMRI). The fMRI data will be analyzed by a Generalized Linear Model approach. Effects of treatment will be determined by comparing the losartan-treated group with the placebo-treated group.

    120 to 150 minutes after treatment

  • fMRI-based indices of neural activity for subsequently successfully remembered as compared to non-remembered stimuli will be compared between the treatment groups

    Neural activation for stimuli that are successfully remembered after an interval of 24hours will be compared to stimuli that are not successfully remembered. Neural activity between the subsequently remembered and non-remembered stimuli will be assessed by functional magnetic resonance imaging (fMRI) acquired during the initial encoding of the stimuli. The fMRI data will be analyzed by a Generalized Linear Model approach. Effects of treatment will be determined by comparing the losartan-treated group with the placebo-treated group.

    120 to 150 minutes after treatment

Secondary Outcomes (3)

  • Self-Assessment Manikin (SAM) ratings of arousal of the stimuli will be compared between the treatment groups

    120 to 150 minutes after treatment

  • Self-Assessment Manikin (SAM) ratings of valence of the stimuli will be compared between the treatment groups

    120 to 150 minutes after treatment

  • Memory performance in terms of correctly recognized stimuli will be compared between the treatment groups

    24 hours after treatment

Study Arms (2)

Losartan group

EXPERIMENTAL

Drug: Losartan

Drug: Losartan

Placebo group

PLACEBO COMPARATOR

Drug: Placebo Oral Tablet

Drug: Placebo Oral Tablet

Interventions

LosartanDRUG

administration of losartan (50 mg) (oral) Cozaar Oral Tablet

Also known as: Cozaar Oral Tablet
Losartan group
Placebo Oral TabletDRUG

administration of placebo (oral)

Placebo group

Eligibility Criteria

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

You may qualify if:

  • Healthy subjects without past or current psychiatric or neurological disorders
  • Right-handedness
  • Normal or corrected-normal version

You may not qualify if:

  • History of head injury
  • Medical or psychiatric illness
  • Hypertension
  • General cardio-vascular alteration or diseases
  • Allergy against medications
  • Visual or motor impairments
  • Claustrophobia
  • Drug addiction
  • Nicotine dependence
  • FMRI contradictions

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

Related Publications (1)

  • Xu T, Zhou X, Jiao G, Zeng Y, Zhao W, Li J, Yu F, Zhou F, Yao S, Becker B. Angiotensin Antagonist Inhibits Preferential Negative Memory Encoding via Decreasing Hippocampus Activation and Its Coupling With the Amygdala. Biol Psychiatry Cogn Neurosci Neuroimaging. 2022 Oct;7(10):970-978. doi: 10.1016/j.bpsc.2022.05.007. Epub 2022 May 30.

    PMID: 35654318DERIVED

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

Weihua Zhao, PhD

CONTACT

86-28-61830811zarazhao.uestc@outlook.com

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

CN(1)