NCT04604938

Brief Summary

This study aims to investigate whether a single dose of losartan (50 mg) can affect learning from positive and negative outcomes and its related 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
17 days until next milestone

First Posted

Study publicly available on registry

October 27, 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 27, 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

LosartanReward reinforcement learning

Outcome Measures

Primary Outcomes (2)

  • BOLD-level activity as assessed by fMRI during the learning phase

    During the paradigm subjects will learn the reward properties of stimuli via the presentation of trial-wise feedback. The neural activation during the prediction of positive and negative outcome feedback will be assessed by functional magnetic resonance imaging (fMRI), particularly in prefrontal and subcortical regions. The effects of treatment will be determined by comparing the losartan- and placebo-treated groups.

    90 minutes to 110 minutes after treatment

  • BOLD-level activity as assessed by fMRI during the learning transfer phase

    Following the initial learning phase subjects learning transfer will be examined by asking subjects to choose between stimuli with high versus low reward probabilities. The neural activation during correct responses will be assessed by functional magnetic resonance imaging (fMRI), particularly in prefrontal and subcortical regions. The effects of treatment will be determined by comparing the losartan- and placebo-treated groups.

    111 minutes to 120 minutes after treatment

Secondary Outcomes (3)

  • Choice accuracy for the stimulus with the high reward probability during the learning phase

    90 minutes to 110 minutes after treatment

  • Learning rate for positive and negative outcomes

    90 minutes to 110 minutes after treatment

  • Choice accuracy during the learning transfer phase

    111 minutes to 120 minutes 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)

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, Kanen JW, Wang L, Li J, Chen Z, Zhang R, Jiao G, Zhou F, Zhao W, Yao S, Becker B. Angiotensin blockade enhances motivational reward learning via enhancing striatal prediction error signaling and frontostriatal communication. Mol Psychiatry. 2023 Apr;28(4):1692-1702. doi: 10.1038/s41380-023-02001-6. Epub 2023 Feb 21.

    PMID: 36810437DERIVED

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 27, 2020

Study Start

October 10, 2020

Primary Completion

December 31, 2021

Study Completion

March 31, 2022

Last Updated

October 27, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)