Losartan and Emotional Learning

NCT06628154 | Recruiting Early Phase 1

• 1 other identifier: R80447
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study explores the effects of single-dose losartan (50mg) versus placebo on emotional processing in healthy volunteers.

Conditions

Emotional Processing

Keywords

emotional processing; reward; anxiety; depression

Outcome Measures

Primary Outcomes (1)

• Reinforcement Learning

  reinforcement learning, calculated as the learning rate from aversive and appetitive decision outcomes. Larger scores indicate better learning from an outcome.

  1 hour after capsule intake

Secondary Outcomes (3)

• Cognitive Flexibility

  1 hour after capsule intake

• AAT effect score

  1hour after capsule intake

• Motivational effort in the Apples Task

  1hour after capsule intake

Study Arms (2)

losartan

EXPERIMENTAL

oral single-dose losartan potassium (Cozaar; 50mg)

Drug: Losartan potassium 50mg

placebo

PLACEBO COMPARATOR

Microcellulose placebo in identical capsule

Other: Placebo

Interventions

Losartan potassium 50mg DRUG

Single dose losartan (50 mg, weight-adjusted), encapsulated identically to placebo

losartan

Placebo OTHER

Single tablet encapsulated identically to losartan

placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Willing and able to provide informed consent
• Aged 18-50 years
• Score of or below 45 on the Dimensional Anhedonia Rating Scale (DARS; Rizvi et al., 2015)
• Sufficient written and spoken English skills to understand what the study involves, and to complete the questionnaires
• Non- or light-smoker (5 cigarettes a day)

You may not qualify if:

• Past or present DSM-5 axis-I diagnosis (based on SCID results at screening) other than anxiety disorder, dysthymia or unipolar depression
• First-degree family member with severe psychiatric illness
• CNS-medication last 6 weeks (including as part of another study)
• Current blood pressure or other heart medication (especially aliskiren or beta blockers)
• Diagnosis of intravascular fluid depletion or dehydration
• History of angioedema
• Impaired kidney function (based on self-report)
• Very low blood pressure (defined as repeated (at least three consecutive measurements) measures of blood pressure under standardised conditions where either the systolic or the diastolic blood pressure or both are below 90/50 mmHg (in accordance with established standard definitions: DOI 10.1186/s12887-016-0633-7))
• Lifetime history of epilepsy or other neurological disease (e.g. autism, ADHD)
• Lifetime history of 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
• Significant loss of hearing that is not corrected with a hearing device
• Women: pregnancy, breast-feeding

Sponsors & Collaborators

• University of Oxford: lead
• Oxford Health Biomedical Research Centre (OH BRC) support scheme: collaborator

Study Sites (1)

Warneford Hospital, University of Oxford

Oxford, Oxfordshire, OX37JX, United Kingdom

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Depression

Interventions

Losartan

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles

Study Officials

• Andrea Reinecke, PhD

  University of Oxford

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Reinecke, PhD

CONTACT

+44 01865 618320; andrea.reinecke@psych.ox.ac.uk

Sanika Kulkarni, MSc

CONTACT

sanika.kulkarni@psych.ox.ac.uk

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double-blind
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel randomised experimental medicine trial

Study Record Dates

• First Submitted: September 30, 2024
• First Posted: October 4, 2024
• Study Start: August 14, 2024
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: October 4, 2024

Record last verified: 2024-09

Locations

GB (1)