Ketogenic Diet and Neuromodulation for Depression
(ALIGN Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The goal of this clinical trial is to test whether combining a ketogenic diet (KD) with personalized, accelerated intermittent theta burst stimulation (iTBS) produces greater reductions in depressive symptoms than iTBS combined with a standard healthy diet in adults with treatment-resistant depression. The trial also aims to determine whether participants can feasibly follow a ketogenic diet during an accelerated iTBS treatment course and whether the diet produces measurable changes in ketone levels.
Specifically, the study aims to determine whether the combined intervention:
1. Reduces depressive symptoms
2. Increases circulating ketone levels
3. Is feasible and tolerable during accelerated iTBS treatment
Participants will begin either a KD or a Canadian Food Guide-aligned diet (CFGD) with a 3-week dietary lead-in period, after which they will undergo a course of personalized, accelerated iTBS while continuing their assigned diet. Before and after the iTBS treatment course, participants will complete clinical assessments, provide blood samples for metabolic testing, and undergo MRI scans to assess brain connectivity. Ketone levels will be measured daily throughout the 12-week dietary intervention. Within-group and between-group differences will be compared to characterize changes in clinical outcomes, metabolism, and brain functioning.
Are You a Good Fit for This Trial?
Adults aged 18-65 with treatment-resistant depression, who haven't responded to at least two antidepressant trials and have never had rTMS or electroconvulsive therapy. Participants must be able to consent, follow a specific diet for 15 weeks, and are currently experiencing a major depressive episode with moderate severity.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dietary Lead-in
Participants begin either a ketogenic diet or a Canadian Food Guide-aligned diet for a 3-week dietary lead-in period
Treatment
Participants undergo a course of personalized, accelerated iTBS while continuing their assigned diet. Clinical assessments, blood samples, and MRI scans are conducted.
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Accelerated Intermittent Theta Burst Stimulation (iTBS)
- Ketogenic Diet
Trial Overview
The trial is testing if a ketogenic diet combined with personalized accelerated iTBS can reduce symptoms of depression more effectively than iTBS with a standard healthy diet. It includes dietary adjustments, iTBS sessions, clinical assessments, blood tests for metabolism, and MRI scans over the course of the study.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants in this arm will begin a well-formulated ketogenic diet (low carbohydrate, moderate protein, high fat) for a 3-week dietary lead-in period prior to neuromodulation, and will continue the diet for a total of 12 weeks. The diet is designed to achieve and maintain nutritional ketosis (blood ketone levels of 0.5 to 3 mmol/L). Dietitian support will be provided through scheduled counseling and ongoing monitoring using daily finger-stick ketone and glucose testing.
Participants in this arm will begin a Canadian Food Guide-aligned diet for a 3-week dietary lead-in period prior to neuromodulation and will continue the diet for a total of 12 weeks. The diet will emphasize balanced intake of vegetables, fruits, whole grains, and protein foods, without specific macronutrient restrictions. Dietitian counseling will be matched in frequency and duration to the ketogenic diet arm. Nutritional monitoring will include dietary logs and metabolic assessments without targeted induction of ketosis. Participants will perform daily finger-stick glucose testing.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sunnybrook Health Sciences Centre
Lead Sponsor
Baszucki Group
Collaborator
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