Major Depressive Disorder study: Ketogenic Diet
Official title Ketogenic Diet and Neuromodulation in Treatment Resistant Depression
ClinicalTrials.gov ID: NCT07376018
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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...
- No rTMS treatment received in the current depressive episode (prior rTMS in a previous episode is permitted)
You likely can't join if
- 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...
- 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...
See the full eligibility 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...
- 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
- 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...
- 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 how well it works
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Toronto, Ontario, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.