💬In plain words
What the trial is, and whether it could suit you
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 le
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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 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
* Diagnosis of any personality disorder assessed by a study investigator to be primary and/or causing greater impairment than MDD
* History of epilepsy, stroke, or major neurological conditions, or a history of a primary seizure disorder or a seizure associated with an intracranial lesion
* Physical or cognitive disability interfering with participation
* Pregnancy, nursing, or intent to become pregnant during 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 Ketogenic diet
* 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
* Contraindications to MRI
* Unwillingness to perform daily finger-stick testing
* Inability to access or prepare KD-compliant foods if assigned
* Unable to provide informed consent on their own
HealthTeky