Ketogenic Diet and Neuromodulation in Treatment Resistant Depression
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSunnybrook Health Sciences Centre
About this trial
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
Eligibility criteria
Qualifiers
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
Disqualifiers
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 stress disorder (current or within the last year), anxiety disorder (generalised anxiety disorder, social anxiety disorder, panic disorder), or dysthymia, assessed by a study investigator to be primary and causing greater impairment than MDD
Trial design
Treatments tested in this trial
- Accelerated Intermittent Theta Burst Stimulation (iTBS)
- Ketogenic Diet
- Canadian Food Guide-Aligned Diet
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Sunnybrook Health Sciences Centre
Lead sponsor
Baszucki Group
Collaborator
Source ClinicalTrials.gov