Fluoxetine on Emotional Experience (FLEX) Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-24
SponsorUniversity of Oxford
About this trial
The goal of this clinical medicine study is to investigate how does antidepressant fluoxetine modulate anger processing in healthy young people . The main questions it aims is to answer are:
1. How does fluoxetine affect responses to anger-related stimuli such as words, faces, and autobiographical recall? 2. How does fluoxetine influence responses during frustration induction in frustrative non-reward and threat paradigms? 3. Does the effect manifest in physiological markers, including heart rate variability and facial expressions?
Researchers will compare fluoxetine to a placebo to see if drug fluoxetine affects anger processing.
Participants will:
Take 20mg fluoxetine or a placebo every day for 7 days. Visit the university site for questionnaire and tasks assessments. Heart rate variability and facial expressions will be recorded in some of the tasks.
Eligibility criteria
Qualifiers
Be aged 18-24 years (inclusive)
Be resident in the UK for the duration of the study
Have normal or corrected to normal vision
Participant is willing and able to give informed consent for participation in the research
Disqualifiers
Current or past diagnosis of any psychiatric disorder, as determined by the Structured Clinical Interview for the DSM-5 (SCID-5) and self-report. This includes, but is not limited to, depression, anxiety disorders, alcohol or drug dependency, personality disorders, suicidal ideation, and other psychiatric conditions;
First degree relative with a diagnosis of mania;
Heavy smoker or vaper (> 10 cigarettes per day, or >2 mL e-liquid, or >15mg/day from a nicotine patch);
Heavy use of caffeine (drink > 4 of 250ml cups/cans of coffee or energy drinks per day);
Trial design
Treatments tested in this trial
- Fluoxetine
- Placebo
Treatment groups
80 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Oxford
Lead sponsor
Wellcome Trust
Collaborator
National Institute for Health Research, United Kingdom
Collaborator
Source ClinicalTrials.gov