Combined Blood Pressure Medication and Activity Scheduling for Low Mood

NCT07017023 | Recruiting Early Phase 1

• 1 other identifier: CUREC reference 660982
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

This study explores the effects of 7-day losartan (50mg) versus placebo with brief behavioural activation on emotional processing in young volunteers low in positive mood

Conditions

Emotional Processing; Mood

Keywords

emotional processing; mood

Outcome Measures

Primary Outcomes (1)

• Change in reinforcement learning

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

  from baseline to post 7-day intervention

Secondary Outcomes (3)

• Change in approach-avoidance-task (AAT) effect score

  from baseline to post 7-day intervention

• Change in social approach decisions

  from baseline to post 7-day intervention

• Change in motivational effort in the Apples Task

  from baseline to post 7-day intervention

Study Arms (2)

Losartan

EXPERIMENTAL

7-day losartan potassium (Cozaar; 50mg; oral tablet) with 7-day BA

Drug: Losartan with BA

Placebo

PLACEBO COMPARATOR

7-day placebo (oral; microcellulose in identical capsules) with 7-day BA

Other: Placebo with BA

Interventions

Losartan with BA DRUG

7-day losartan (Cozaar, 50mg; oral tablet) with 7-day BA

Losartan

Placebo with BA OTHER

7-day placebo (oral; microcellulose in identical capsules) with 7-day BA

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to provide informed consent
• Aged 18-65 years
• Self-reported low levels of positive mood
• Sufficient written and spoken English skills to understand study procedures
• Normal or corrected to normal vision and hearing
• Access to a computer and reliable internet connection

You may not qualify if:

• Antidepressant treatment or medication in last three months
• Currently receiving cognitive-behavioural therapy with behavioural activation
• History of psychosis or bipolar disorder
• History of substance dependence
• Use of illegal drugs in last 3 months
• First-degree relative with history of psychosis or bipolar disorder
• Current or past hospitalisation for mental health reasons
• BDI-II score \>30
• Judged to be currently at clinical risk of suicide
• Past suicide attempt
• CNS-medication last 6 weeks (including in another study)
• Severely underweight or overweight in a manner that renders them unsuitable for the study in the opinion of the study medic
• Current blood pressure or other heart medication
• Diagnosis of intravascular fluid depletion or dehydration
• History of angioedema

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

Warneford Hospital, University of Oxford

Oxford, Oxfordshire, OX37JX, United Kingdom

RECRUITING

MeSH Terms

Interventions

Losartan

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

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

Rowan Haslam, MSc

CONTACT

rowan.haslam@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: May 19, 2025
• First Posted: June 12, 2025
• Study Start: July 8, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 24, 2025

Record last verified: 2025-06

Locations

GB (1)