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New treatment option for Depression - Major Depressive Disorder
Official title Fluoxetine on Emotional Experience (FLEX) Study
ClinicalTrials.gov ID: NCT07424781
What this study is testing
What is Fluoxetine?
Fluoxetine is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for depression - major depressive disorder.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 24. Healthy volunteers may be eligible.
You may be able to join if
- 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
- Sufficiently fluent English to understand and complete the study
You likely can't join if
- The participant may not enter the study if ANY of the following apply: Psychiatric History:
- Current or past diagnosis of any psychiatric disorder, as determined by the Structured Clinical Interview for the DSM-5 (SCID-5) and self-report...
- First degree relative with a diagnosis of mania; Lifestyle:
- 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);
- Heavy drinker (drink \>14 standard alcoholic drinks per week);
See the full eligibility criteria
- 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
- Sufficiently fluent English to understand and complete the study
- The participant may not enter the study if ANY of the following apply: Psychiatric History:
- 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...
- First degree relative with a diagnosis of mania; Lifestyle:
- 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);
- Heavy drinker (drink \>14 standard alcoholic drinks per week);
- Current or recent use (in the last 3 months) of any psychoactive substance according to self-report and a urine drug test screening for recent use of 10 common recreational substances; Physical Health:
- Severely underweight or overweight in a manner that renders them unsuitable for the study in the opinion of the study medical advisor;
- Known contraindication to fluoxetine, such as hypersensitivity to fluoxetine or any component in its formulation;
- Pregnancy, as determined by a urine pregnancy test or plans to become pregnant within the next 3 months;
- Breastfeeding;
- Not able to consume gelatine; Medical History:
- Past or ongoing health issue which, in the opinion of the study medical advisor, may interfere with the safety of the participant or the scientific integrity of the study, including but not limited to: seizures or...
- Diagnosis of a significant neurological condition (e.g., epilepsy, multiple sclerosis, traumatic brain injury).
- Diagnosis of a neurodevelopmental condition, such as autism spectrum disorder (ASD) or attention-deficit/hyperactivity disorder (ADHD);
- Current or recent use of medication that might interfere or interact with the effects of fluoxetine, in the opinion of the study medical advisor, including but not limited to: monoamine oxidase inhibitors (MAOIs)...
- Participation in any other psychological or medical experiment involving taking any kind of drug/medication/vaccine, within the last 3 months;
- Participation in any other study involving the current or similar tasks, within the last 6 months; Others Any other significant finding which may arise during the screening process and which, in the opinion of the...
The study team makes the final eligibility decision.
Where it's taking place
- Oxford, Oxfordshire, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 24 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Oxford, Oxfordshire, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.