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:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-24 @ 11:54 PM
NCT ID:
NCT06805851
Eligibility Criteria:
Inclusion Criteria:
* Non-depressed adults aged 18-40 years;
* OR adults aged 18-40 years with clinically diagnosed major depressive disorder according to DSM-V criteria not currently receiving antidepressant treatment;
* OR adults aged 18-40 years with clinically diagnosed major depressive disorder with at least 2 weeks of treatment with a selective serotonin reuptake inhibitor;
* OR aged 18-40 years adults with clinically diagnosed major depressive disorder with at least 2 weeks of treatment with a serotonin norepinephrine reuptake inhibitor;
* All participants will be asymptomatic and no signs/symptoms of disease according to the American College of Sports Medicine 10th edition Guidelines for Exercise Testing and Prescription (chest pain or pressure, dizziness, joint pain, and signs of cardiovascular disease);
* Systolic blood pressure 140 mmHg and diastolic pressure 90 mmHg at screening;
* Non-diabetic
* Not taking any other medications that might affect the physiological variables of interest (beta blockers, tricyclic antidepressants, antipyretics, diuretics, etc.);;
* Between the 20th and 80th percentiles for sex- and age-appropriate VO2max according to the American College of Sports Medicine 10th edition Guidelines for Exercise Testing and Prescription;
* English proficiency;
* Capable of providing informed consent.
Exclusion Criteria:
* BMI \> 35
* Are pregnant or planning to become pregnant in the next 12 months;
* Concurrently participate in another study involving physical activity or weight loss;
* Plan to have surgery or relocate outside the area within the next year;
* Medications that could alter cardiovascular or thermoregulatory responses to exercise (beta blockers, antipyretics, tricyclic antidepressants, diuretics, etc.);
* Allergy to latex or adhesive;
* Tobacco use;
* Illegal/recreational drug use;
* Exertional chest pain or musculoskeletal pain;
* Contraindications to a maximal exercise test or an indication for early termination of the exercise test according to the American College of Sports Medicine 10th edition Guidelines for Exercise Testing and Prescription;
* Abnormal resting or exercise electrocardiogram (ECG);
* Any bleeding disorders, gastric ulcers, allergies to NSAIDS, asthma, kidney/liver disorders, and taking any other anticoagulants;
* History of Crohn's disease, diverticulitis, or similar gastrointestinal disease;
* Co-morbid psychiatric disorders (psychosis, schizophrenia, bipolar disorder, panic disorder, obsessive compulsive disorder, etc.);
* Active suicidal ideation (moderate or high suicidality);
* Use of psychoactive or psychopharmacological drugs other than SSRI and SNRIs within one year of participating.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT06805851
Study Brief:
Protocol Section:
NCT06805851