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:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-26 @ 3:20 PM
NCT ID:
NCT07376018
Eligibility Criteria:
Inclusion Criteria:
* Age 18-65 of any sex, gender identity, ethnicity and socioeconomic status
* Currently experiencing a major depressive episode as defined by DSM-5-TR criteria and confirmed by a study physician
* Presenting with at least moderate symptom severity (MADRS ≥ 20)
* Meeting criteria for treatment-resistant depression (TRD), defined as non-response to at least two adequate antidepressant trials
* Neuromodulation-naïve (no past rTMS or electroconvulsive therapy)
* Able to provide informed consent
* Available for the 15-week intervention and willing to follow either a ketogenic or Canadian Food Guide-aligned diet
Exclusion Criteria:
* Medical/psychiatric co-morbidities that prevent participation in the study or where depression is not the primary psychiatric symptom of concern
* History of epilepsy, stroke, or major neurological conditions, psychosis, or substance dependence within the last 6 months
* Physical or cognitive disability interfering with participation
* Females who are pregnant (self-report or via blood work), nursing, or planning a pregnancy during the timespan of the study BMI \< 20 kg/m²
* Suicide attempts in the past 12 months
* Active suicidal intent as confirmed by study psychiatrist
* Active eating disorder in the past 12 months
* Currently following a KD
* Habitual low-carb diet in the past 6 months
* GI disorders or food allergies incompatible with dietary protocols
* Alcohol use \>3 drinks/day or \>14/week
* Use of anticonvulsants (benzodiazepines with a dose of \<2 lorazepam equivalents will be permitted), GABA agonists, or medications reducing TMS efficacy
* Serious medical illness
* Contraindications to MRI
* Unwillingness to perform daily finger-stick testing
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT07376018
Study Brief:
Protocol Section:
NCT07376018