NCT03396523

Brief Summary

The aim of the study is to investigate the effect of losartan (50mg, single dose) on the extinction of conditioned fear

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
70

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Jan 2018

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

January 4, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

January 4, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 11, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

June 6, 2018

Status Verified

June 1, 2018

Enrollment Period

10 months

First QC Date

January 4, 2018

Last Update Submit

June 4, 2018

Conditions

Keywords

LosartanFear extinction

Outcome Measures

Primary Outcomes (1)

  • Losartan effects on neural activity during fear extinction

    Neural activity will be measured by functional magnetic resonance imaging (fMRI). Effects of treatment will be evaluated by comparing extinction-related neural activity in the core extinction network (prefrontal cortex, limbic regions) between the active treatment and the placebo group.

    1 hour

Secondary Outcomes (1)

  • Losartan effects on skin conductance responses during fear extinction

    1 hour

Study Arms (2)

Losartan group

EXPERIMENTAL
Drug: Losartan

Placebo group

PLACEBO COMPARATOR
Drug: Placebo Oral Tablet

Interventions

administration of losartan (50 mg) (oral)

Also known as: Cozaar Oral Tablet
Losartan group

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

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

Related Publications (1)

  • Zhou F, Geng Y, Xin F, Li J, Feng P, Liu C, Zhao W, Feng T, Guastella AJ, Ebstein RP, Kendrick KM, Becker B. Human Extinction Learning Is Accelerated by an Angiotensin Antagonist via Ventromedial Prefrontal Cortex and Its Connections With Basolateral Amygdala. Biol Psychiatry. 2019 Dec 15;86(12):910-920. doi: 10.1016/j.biopsych.2019.07.007. Epub 2019 Jul 25.

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

January 4, 2018

First Posted

January 11, 2018

Study Start

January 4, 2018

Primary Completion

October 31, 2018

Study Completion

December 31, 2018

Last Updated

June 6, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations