Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-25 @ 2:00 AM
NCT ID:
NCT05957094
Eligibility Criteria:
Inclusion Criteria:
* 15 healthy participants - mix of male and female - between 18 and 35 years of age will be recruited.
The maximum age of 35 was chosen so as to confine this study to "young adults", there is sufficient evidence to suggest that there is great variation of vascular responses to various stimuli across lifetime. As such, including participants from a larger range of ages would inevitably increase the physiological variability of the measures collected and thereby dilute the potential findings. Before assessing the effects of SSRI on CBF and ventilatory responses across the lifetime, we must first assess it in a single age-range cohort, to determine "young healthy normative" data.
Exclusion Criteria:
* Participants will be excluded from the study if they are:
* taking any medications,
* are or have recently (within the previous 6 months) been pregnant (self-reported - or pregnancy test result),
* currently smoke or smoked within the previous year,
* have had, or currently have cardiovascular, metabolic, respiratory, or neurological disease,
* are obese (BMI\>30kg/m2),
* have had any invasive cerebral surgical procedures,
* have a cardiac pacemaker,
* we are unable to attain reliable ultrasound images of their neck arteries,
* currently or within the previous year have been prescribed SSRIs or other serotonergic drugs (tryptophan, triptans, lithium, fentanyl and its analogues, dextromethorphan, tramadol, tapentadol, meperidine, methadone and pentazocine or St. John's Wort),
* currently or within the previous year been prescribed monoamine oxidase inhibitors (another kind of anti-depressant),
* have recently (within the previous two weeks) used drugs including lysergic acid diethylamide (LSD), psilocybin (magic mushrooms), cocaine, or 3,4-Methylenedioxymethamphetamine (MDMA, ecstasy) (these drugs work via serotonin related mechanisms).
Both females and males will be tested. Contraceptive use will be noted but will not be part of any exclusion criteria. Phase of menstrual cycle will be noted but will not be part of any exclusion criteria, though females will be tested within the early follicular phase of menstruation, or the placebo phase of contraceptive use, and tested in the same (self-reported) phase of the next menstrual cycle.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
35 Years
Study:
NCT05957094
Study Brief:
Protocol Section:
NCT05957094