Health TrialsbyHealthPanel

Fluoxetine on Emotional Experience (FLEX) Study

ConditionsDepression - Major Depressive DisorderIrritabilityDepression
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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Fluoxetine

    Drug

    Participants will receive 20mg of fluoxetine daily for 7 days. Tablets encapsulated to aid blinding.

  • Placebo

    Drug

    Participants will receive one dose placebo (sucrose) daily for 7 days. Tablets encapsulated to aid blinding.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: fluoxetineActive comparator 1 intervention
Group B: placeboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Behavioral Measure: Facial Expression Recognition Task (FERT)

Recognition of angry faces in the Facial Expression Recognition Task

Time frame
On the last day of the 7-day treatment

Secondary outcomes

1

Behavioural Measure: The Affordances Task

Performance on an affordances task in which participants have to decide to fight or escape under threatening situations with different environmental affordance conditions.

Time frame
On the last day of the 7-day treatment
2

Behavioural Measure: Emotional Categorization Task (ECAT)

Performance on recognising and memorising anger related words in the Emotional Categorization Task (ECAT)

Time frame
On the last day of the 7-day treatment.
3

Performance on Carnival Task

Performance on an anger induction task in which the study's rigged design creates frustrating non-reward responses.

Time frame
On the last day of the 7-day treatment.
4

Subjective Measure: Rest Task

Participants' rating of anger-related emotions during a resting task.

Time frame
On the last day of the 7-day treatment.

Other outcomes

Sponsors and contacts

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

University of Oxford

Lead sponsor

Wellcome Trust

Collaborator

National Institute for Health Research, United Kingdom

Collaborator

Source ClinicalTrials.gov
Apply now