NCT03763409

Brief Summary

This study explores the effects of single-dose losartan (50mg) versus identical placebo capsule on emotional memory and learning in healthy volunteers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

March 1, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 27, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 4, 2018

Completed
Last Updated

December 6, 2018

Status Verified

November 1, 2018

Enrollment Period

7 months

First QC Date

November 27, 2018

Last Update Submit

December 4, 2018

Conditions

Keywords

anxietylosartanappetitive learningaversive learning

Outcome Measures

Primary Outcomes (1)

  • aversive and appetitive learning

    a learning task wil assess to what degree participants learn from win versus loss outcomes in different environments

    1 hour after capsule intake

Study Arms (2)

losartan

EXPERIMENTAL

50 mg single-dose oral losartan

Drug: Losartan Potassium

placebo

PLACEBO COMPARATOR

microcellulose placebo in identical capsule

Other: placebo

Interventions

active drug

losartan
placeboOTHER

placebo

placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • willing and able to provide informed consent
  • male or Female, aged 18-50
  • body mass index (BMI) of 18-30 kg/m2
  • fluent English skills
  • non- or light-smoker (\< 5 cigarettes a day)

You may not qualify if:

  • Female participant who is pregnant or breast-feeding
  • CNS-active medication during the last 6 weeks
  • Current blood pressure or other heart medication (especially aliskiren or beta blockers)
  • Intravascular fluid depletion
  • Past or present DSM-IV axis-I diagnosis or suspected diagnosis (from SCID results at screening)
  • Alcohol or substance abuse
  • First-degree family member with a history of a severe psychiatric disease
  • Impaired liver or kidney function
  • Lifetime history of epilepsy or other neurological disease, systemic infection, or clinically significant hepatic, cardiac, obstructive respiratory, renal, cerebrovascular, metabolic, endocrine or pulmonary disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
  • Insufficient English skills
  • participated in another study involving CNS-active medication during the last 6 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychiatry, University of Oxford

Oxford, OX37JX, United Kingdom

Location

Related Publications (1)

  • Pulcu E, Shkreli L, Holst CG, Woud ML, Craske MG, Browning M, Reinecke A. The Effects of the Angiotensin II Receptor Antagonist Losartan on Appetitive Versus Aversive Learning: A Randomized Controlled Trial. Biol Psychiatry. 2019 Sep 1;86(5):397-404. doi: 10.1016/j.biopsych.2019.04.010. Epub 2019 Apr 17.

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Losartan

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
double-blind
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Parallel randomised
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2018

First Posted

December 4, 2018

Study Start

March 1, 2018

Primary Completion

September 28, 2018

Study Completion

September 28, 2018

Last Updated

December 6, 2018

Record last verified: 2018-11

Locations