Losartan and Emotional Processing in Young People
ConditionEmotional Processing
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age16-20
SponsorUniversity of Oxford
About this trial
This study explores the effects of single-dose losartan (50mg) versus placebo on emotional processing in young healthy volunteers.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Willing and able to provide informed consent (for 16 and 17 year olds: assent and parental/ legal guardian consent)
Non- or light-smoker (< 5 cigarettes a day)
Ability to attend appointments in Oxford with reasonable travel costs
Ability/ willingness to provide GP contact details
Disqualifiers
Past or present DSM-5 axis-I diagnosis (based on SCID results at screening), especially severe psychiatric illness or alcohol or substance dependence
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Losartan potassium
DrugSingle dose losartan (25mg or 50 mg, weight-adjusted), encapsulated identically to placebo
Placebo
Other interventionSingle tablet encapsulated identically to placebo
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: losartanExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Fear Extinction
fear extinction score, computed as a 5-point Likert scale valence rating (1=unpleasant-5=pleasant) of the CS+ stimulus at the end of extinction minus at the end of acquisition, with larger scores indicating better fear extinction
Time frame
1 hour after capsule intakeSecondary outcomes
1
Pattern Separation
Lure discrimination index (LDI), calculated as the rate of 'similar' responses to lures minus 'similar' responses to foils, with higher scores indicating better mnemonic discrimination
Time frame
1 hour after capsule intake2
Cognitive Flexibility
switch cost, calculated by rank-ordering the differences between each switch trial RT and each participants average RT for all non-switch trials from 1 - 10 (with better and worse bins having values closer to 1 and 10, respectively), and then summing the bin values to compute a total bin score for each participant. Inaccurate responses are penalized by being assigned a score of 20. Smaller bin scores indicate greater accuracy and lower RT.
Time frame
1 hour after capsule intake3
Reinforcement Learning
reinforcement learning, calculated as the learning rate from aversive and appetitive decision outcomes. Larger scores indicate better learning from an outcome.
Time frame
1 hour after capsule intake4
Faces Dot Probe Task
extradecisional threat bias, calculated by subtracting the extradecisional time parameter for congruent trials from the extradecisional time parameter for incongruent trials. Larger scores indicate a greater degree of vigilance to threat.
Time frame
1 hour after capsule intakeSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Oxford
Lead sponsor
National Institute for Health Research, United Kingdom
Collaborator
Source ClinicalTrials.gov