Accelerated Intermittent Theta Burst Stimulation (iTBS) / Canadian Food Guide-Aligned Diet / Treatment Resistant Depression (TRD) · Interventional Study

Ketogenic Diet and Neuromodulation in Treatment Resistant Depression

ClinicalTrials.gov · August 7, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a planned interventional study comparing ketogenic diet combined with accelerated iTBS against standard diet combined with iTBS in adults with treatment-resistant depression. No results have been posted to the registry; the trial is not yet recruiting. The study is designed to assess depression symptom improvement, ketone level changes, and safety/tolerability over 12 weeks.

What was studied

Interventional, Randomized, Parallel, Single masking, Treatment purpose. Major Depressive Disorder (MDD), Treatment Resistant Depression (TRD); age from 18 Years; to 65 Years. Intervention: Ketogenic Diet. Compared with: Canadian Food Guide-Aligned Diet — Active Comparator. n = 60. 1 site: Canada.

Key findings

Safety

This is a registry record only; no results, efficacy data, or safety outcomes are reported.

Who this may help

This trial is not yet enrolling and has reported no results. Clinicians should monitor for completion and results publication to determine whether combined ketogenic diet and iTBS offers advantage over iTBS with standard diet in TRD populations.

Plain-language summary

This is a planned interventional trial with no results reported; it addresses a novel combination (ketogenic diet + iTBS for TRD) in a small estimated sample, making it preliminary in nature pending enrollment and outcome reporting.

Study design

As stated by the source record.

MethodsPrimary outcome measures: Change in Depression Score on the Montgomery-Asberg Depression Rating Scale (MADRS) (assessed at Baseline, Week 5 (post-iTBS), Week 8 (post-iTBS), Week 12 (post-iTBS)); Changes in Ketone Levels (assessed at Baseline through week 12); Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (assessed at Baseline through week 12)

DesignInterventional, Randomized, Parallel, Single masking, Treatment purpose

PopulationMajor Depressive Disorder (MDD), Treatment Resistant Depression (TRD); age from 18 Years; to 65 Years

Sample size60

InterventionKetogenic Diet

ComparatorCanadian Food Guide-Aligned Diet — Active Comparator

Setting1 site: Canada

Reported figures

Quoted from the source exactly as published.

Planned sample size60

Primary outcome measure 1Change in Depression Score on the Montgomery-Asberg Depression Rating Scale (MADRS), measured at Baseline, Week 5, Week 8, Week 12

Primary outcome measure 2Changes in Ketone Levels, Baseline through week 12

Primary outcome measure 3Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability], Baseline through week 12

Study duration12 weeks active intervention (including 3-week diet lead-in before iTBS)

Clinical bottom line

Caveats

This is a registry record only; no results, efficacy data, or safety outcomes are reported.
Recruitment status is NOT_YET_RECRUITING; enrollment has not begun.
Registry does not specify randomization method, blinding procedures, or allocation concealment.
Phase is listed as NA; unclear whether this is Phase 2, Phase 3, or proof-of-concept.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Interventional, comparative design with two diet arms plus iTBS; phase not specified.

Directness

strong

Directly addresses treatment-resistant depression in adults; combines device and behavioral interventions.

Consistency

insufficient

No results yet reported; no comparison to prior evidence possible.

Risk of bias

insufficient

Registry record does not describe blinding, randomization method, or allocation concealment.

Sample adequacy

limited

Estimated 60 participants total; small sample for a comparative effectiveness trial.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07376018). This is a study registration, not published results. Lead sponsor: Sunnybrook Health Sciences Centre. Recruitment status: NOT_YET_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 60 participants (ESTIMATED). Conditions: Major Depressive Disorder (MDD), Treatment Resistant Depression (TRD). Interventions: DEVICE: Accelerated Intermittent Theta Burst Stimulation (iTBS); BEHAVIORAL: Ketogenic Diet; BEHAVIORAL: Canadian Food Guide-Aligned Diet. Primary outcome measures: Change in Depression Score on the Montgomery-Asberg Depression Rating Scale (MADRS) , Baseline, Week 5 (post-iTBS), Week 8 (post-iTBS), Week 12 (post-iTBS); Changes in Ketone Levels , Baseline through week 12; Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] , Baseline through week 12. Brief 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

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Accelerated Intermittent Theta Burst Stimulation (iTBS)Canadian Food Guide-Aligned DietNCT07376018Sunnybrook Health Sciences CentreTreatment Resistant Depression (TRD)Major Depressive Disorder (MDD)Ketogenic Diet