Could a keto diet boost brain zaps for depression?
NCT ID NCT07376018
First seen Jun 24, 2026 · Last updated Aug 07, 2026 · Updated 2 times
Summary
This study tests whether adding a ketogenic (low-carb) diet to a non-invasive brain stimulation treatment called iTBS helps people with treatment-resistant depression feel better. Sixty adults will follow either a keto diet or a standard healthy diet for three weeks, then receive personalized brain stimulation while staying on their diet. Researchers will measure changes in depression scores, ketone levels, and brain scans to see if the combination is safe and effective.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ketogenic diet
- What this could lead to
- If it works, this could point toward a new way to boost the effects of brain stimulation for people with hard-to-treat depression.
- What could go wrong
- This is a small early-stage trial with only 60 people. The diet is hard to follow, and the added benefit over brain stimulation alone is unproven. Side effects like low blood sugar or stomach issues are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Jan 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
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Other studies related to the condition(s) this trial covers.
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