Combined Blood Pressure Medication and Activity Scheduling for Low Mood

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Oxford

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Losartan with BA

    Drug

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

  • Placebo with BA

    Other intervention

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

Treatment groups

76 Participants
are divided into 2 treatment groups
Group A: LosartanExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

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.

Time frame
from baseline to post 7-day intervention

Secondary outcomes

1

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

mean reaction time of the pull trials of a valence category subtracted from the push trials of the same category, yielding a single indicator of approach/avoidance, with positive scores indicating relatively stronger approach and negative scores indicating relatively stronger avoidance

Time frame
from baseline to post 7-day intervention
2

Change in social approach decisions

% approach vs avoid decisions

Time frame
from baseline to post 7-day intervention
3

Change in motivational effort in the Apples Task

The task weighs effort costs against reward value. It involves a hand dynamometer to record effort. On each trial, participants receive an offer showing a reward (number of apples shown on a tree) and an effort level (height of marking on the tree trunk), which they can accept or reject (Yes/No response). On a subset of accepted trials, participants have to exert physical effort on the hand dynamometer to earn the reward (number of apples in the respective trial). Participants receive monetary reward for the number of apples collected. Key outcome marker is effort-reward valuation, i.e. % accepted trials based on combinations of effort and reward levels. Other outcomes: Force exerted relative to Maximum Voluntary Contraction (MVC), Reaction times of Yes/No.

Time frame
from baseline to post 7-day intervention

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.