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Depression Pilot Trial Demonstrates Tolerability, Adherence, and Clinical Remission Following 14-weeks of Remotely Delivered Ketogenic Therapy

Diagnosis

Major Depressive Disorder, Bipolar Depression

Principal Investigator

Elisa Brietzke, MD, PhD

Institution

Queen’s University and Kingston Health Sciences Centre

Location

Kingston, Ontario, Canada

This study is the second-ever published peer-reviewed pilot clinical trial to evaluate a ketogenic diet as a treatment for depression. Conducted in a fully virtual, medically supervised setting, the trial demonstrated high adherence and significant clinical improvements in depression, anxiety, and anhedonia, suggesting that ketogenic therapy is a feasible and impactful adjunctive intervention when delivered with consistent support.

Read the Peer-Reviewed Paper
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Remote Keto Therapy for Depression? Results from New Clinical Evidence

What began as a bold idea, that metabolic dysfunction plays a role in depression, evolved into a fully remote clinical intervention.

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Overall, our findings demonstrate feasibility, with high adherence rates, favorable tolerability, and meaningful clinical improvements. – Dr. Elisa Brietzke

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Medically Supervised Ketogenic Diet as an Adjunctive Treatment for Moderate to Severe Depression: A Pilot Study

This peer-reviewed pilot trial, published in the Journal of Affective Disorders, tested a 14-week ketogenic diet intervention delivered fully virtually to adults living with moderate to severe depression. Participants received individualized support from a registered dietitian, including a 2-week gradual, stepwise induction protocol followed by 12 weeks focused on maintaining ketosis. Diets were individualized to cultural preferences and financial realities, increasing accessibility and adherence.

Of the 11 individuals who began the study, 8 entered and completed the full 12-week maintenance phase. Seven of the eight participants (87.5%) achieved clinical remission, with an average 23-point reduction on a validated depression scale (MADRS).

Of note, 100% of participants who entered the maintenance phase completed the trial. The three non-completers left the trial during the initial two-week induction phase, suggesting that once participants were in a stable state of ketosis, they were motivated to complete the trial.

Participants also showed improvements in anxiety and anhedonia (difficulty experiencing pleasure), with an average reduction of 8.8 points on the GAD-7 anxiety scale and 4.8 points on the SHAPS anhedonia scale. Side effects were generally mild and limited to the early 2-week induction phase of the intervention, and no serious adverse events occurred.

This study is one of the first to demonstrate that a medically supervised ketogenic diet can be safely and effectively implemented in a remote outpatient setting for people living with depression. The results highlight the benefits of a slow introduction to the diet, the importance of consistent diet support, and the need for further investigation through larger, randomized controlled trials.

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