Ketogenic Diet and Neuromodulation in Treatment Resistant Depression (NCT07376018) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Ketogenic Diet and Neuromodulation in Treatment Resistant Depression
Canada60 participantsStarted 2026-08
Plain-language summary
The goal of this clinical trial is to learn if combining a ketogenic diet with a personalized, accelerated brain stimulation treatment (iTBS) works better than iTBS with a standard healthy diet to reduce depression symptoms in adults with treatment-resistant depression. The main questions it aims to answer are:
* Does iTBS combined with a ketogenic diet improve depression symptoms more than iTBS combined with a standard healthy diet?
* Does the ketogenic diet change ketone levels over time?
* Is it safe, tolerable, and feasible to follow a ketogenic diet during accelerated iTBS treatment?
We will compare a ketogenic diet to a Canadian Food Guide-aligned diet, both combined with iTBS, measuring depression severity using standard clinician-rated and self-report scales.
Participants will:
* Follow either a ketogenic diet or a standard healthy diet for 12 weeks, starting with a 3-week lead-in period before iTBS begins
* Undergo a course of personalized, imaging-guided accelerated iTBS while continuing their assigned diet
* Complete clinical and cognitive assessments, blood tests, and brain MRI scans before and after treatment
* Have their ketone levels checked regularly throughout the 12-week period
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 (PHQ ≥ 10)
* Meeting criteria for treatment-resistant depression (TRD), defined as either: (1) failure to achieve a clinical response to ≥2 adequate antidepressant treatment trials for unipolar depression, OR (2) inability to tolerate ≥2 separate antidepressant treatment trials for unipolar depression, as assessed using the Antidepressant Treatment History Form (ATHF), with a score of ≥3 in the current episode
* No rTMS treatment received in the current depressive episode (prior rTMS in a previous episode is permitted); no failure to respond to a course of electroconvulsive therapy (ECT) in the current depressive episode
* Able to provide informed consent
* Available for the 12-week intervention and willing to follow either a ketogenic or Canadian Food Guide-aligned diet
* No increase or initiation of any antidepressant or antipsychotic medication in the 4 weeks prior to screening
Exclusion Criteria:
* Concomitant major unstable medical illness as determined by a study physician
* Lifetime diagnosis of bipolar I or bipolar II disorder, or a primary psychotic disorder, as confirmed by a structured psychiatric interview
* Current psychotic symptoms
* Diagnosis of obsessive-compulsive disorder, post-traumatic str…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Depression Score on the Montgomery-Asberg Depression Rating Scale (MADRS)