Ketogenic diet for treating major depressive disorder

Effects and Mechanistic Aspects of Ketogenic Diet in Individuals With Major Depressive Disorder: A Pilot Study

This study is testing if a ketogenic diet can help people with major depressive disorder who haven't found relief from regular antidepressants.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Queen's University (Academic / other)
• Locations: 1 site (Kingston, Ontario)
• Trial ID: NCT05558995 on ClinicalTrials.gov

What this trial studies

This program investigates the feasibility, safety, and tolerability of a ketogenic diet as an adjunctive treatment for individuals with Major Depressive Disorder (MDD) who have not fully responded to standard antidepressants. The study involves a 12-week open-label design, including a 2-week induction phase followed by a 10-week maintenance phase. A total of 15 participants will be enrolled, and their adherence to the diet, tolerability, and safety will be assessed. Additionally, biomarkers related to neuroplasticity will be evaluated to explore the potential mechanisms of action of the ketogenic diet in the brain.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 50 with a confirmed diagnosis of major depressive disorder who have not responded adequately to SSRIs.

Not a fit: Patients with psychotic features, bipolar disorder, or significant vitamin and mineral deficiencies may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide an alternative treatment option for patients with MDD who do not achieve remission with conventional antidepressants.

How similar studies have performed: While the ketogenic diet has shown promise in other conditions like epilepsy, its application in treating major depressive disorder is still novel and largely untested.

Eligibility criteria

Inclusion Criteria:

* Diagnostic criteria for single episode or recurrent MDD, without psychotic features, according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), and confirmed by the Mini International Neuropsychiatric Interview (MINI).

  -- Moderate or severe depressive syndrome, as defined by a Montgomery-Asberg Depression Rating Scale (MADRS) total score greater than or equal to (\>=) 20 at baseline.
* Treatment with SSRIs for at least 6 weeks, with no changes in dosing for the past 3 weeks.
* Must be capable of providing informed consent, based on the opinion of the participating physician.
* No vitamin and mineral deficiencies, specifically: vitamin B (B1, B3, B6, B9, and B12), vitamin D, iron, zinc, electrolytes (Na, K), calcium, and magnesium.

Exclusion Criteria:

* Has a current or prior diagnosis of schizophrenia spectrum disorders or bipolar disorder or related disorders, or intellectual disability, according to DSM-5.
* Has current or prior diagnosis of epilepsy
* Has homicidal ideation/intent or is at imminent risk of suicide per the physician's clinical judgment and/or based on the Columbia-Suicide Severity Rating Scale (C-SSRS) corresponding to a response of "Yes" on Item 4 (active suicidal ideation with some intent to act, without specific plan) or Item 5 (active suicidal ideation with specific plan and intent)
* Has received electroconvulsive therapy in the past 6 months. - Made use of caloric restriction, intermittent fasting, and carbohydrates restriction in the 4 weeks prior the inclusion.
* Adoption of specific dietetic habits: vegan, gluten-free, lactose-free diets or currently doing fasting for religious purposes.
* Has evidence of alcohol or drug dependence (except for nicotine and caffeine) according to DSM-5 or within 6 months prior to enrolment
* Has participated in or is currently enrolled in any clinical trial or observational study within the current episode.
* Has a medical contra-indication for ketogenic diet (e.g. metabolic disorder, cardiac arrhythmia, pregnancy or breastfeeding).

Where this trial is running

Kingston, Ontario

• Queen's University - Kingston General Hospital — Kingston, Ontario, Canada (Recruiting)

Study contacts

• Principal investigator: Elisa Brietzke, MD,PhD — Queen's University
• Study coordinator: Elisa Brietzke, MD,Ph.D

Conditions Major Depressive Disorder; Ketogenic Diet; Major depressive disorder