Peer-reviewed clinical pilot trial reports dramatic improvements in psychiatric and metabolic outcomes in bipolar disorder and schizophrenia

SAN MATEO, Calif., April 1, 2024  — The field of psychiatry may have a new ally in the form of a medical ketogenic diet, according to the findings of a pioneering pilot study published in Psychiatry Research and announced today by Stanford Medicine. The study, supported by funding from Baszucki Group and others, is the first U.S.-based clinical trial to examine the therapeutic impact of a ketogenic dietary intervention for serious mental illness since 1965.

Led by Stanford University School of Medicine’s Shebani Sethi, MD, ABOM, Founding Director of the Stanford Metabolic Psychiatry Clinic and Clinical Associate Professor of Psychiatry, the study represents a significant step forward in exploring the connection between metabolism and psychiatry, and in driving toward new treatment approaches in the growing epidemic of mental illness worldwide. The study trialed a 4-month intervention of a low carbohydrate ketogenic diet with individuals diagnosed with bipolar disorder or schizophrenia who also were either overweight or met criteria for metabolic abnormalities such as insulin resistance or impaired glucose tolerance.

The results offer compelling evidence of the potential benefits of ketogenic dietary therapy in this population. The dual improvements in both metabolic function and psychiatric symptoms are rare in mental healthcare, where treatments often lead to significant comorbidities, including weight gain, obesity, dyslipidemia, and cardiometabolic disease.

Can a keto diet treat mental illness? | 90 Seconds w/ Lisa Kim (courtesy of Stanford Medicine)

Key findings of the single-arm pilot trial include:

• 79% of participants showed clinically meaningful psychiatric improvement – 1 point change or more on the Clinical Global Impression scale (CGI).
• 75% of participants were in recovery or a recovered state at the study’s conclusion (on a Clinical Mood Monitoring Scale (CMM)).
• 100% of participants who met the criteria for metabolic syndrome were in remission by the end of the study.
• 100% of fully adherent participants achieved a recovered state at the study’s conclusion, demonstrating a correlation between the frequency of achieving nutritional ketosis and the level of symptom improvement.
• Reductions were seen in weight, body mass index (BMI), waist circumference, and visceral adipose tissue.
• Improvements were seen in insulin sensitivity, quality of life, and sleep.
• Improvements were identified across all psychiatric measures.
• A ketogenic nutritional intervention was safe and feasible with a high adherence rate.

Dr. Sethi shared: “These results are encouraging and suggest that a ketogenic diet intervention could serve as a valuable adjunctive treatment for individuals living with serious mental illness. The dual metabolic and psychiatric improvements observed in our study represent novel findings in psychiatry, warranting further investigation.”

Participants in the trial expressed enthusiasm about the 4-month intervention, as reported in the published paper:

• “My opportunity to participate in the metabolic psychiatry study transformed my life. I gained knowledge, became able-bodied again and my mood disorder and eating disorder symptoms lessened dramatically.”
• “It can honestly save a lot of lives. It saved mine. I would not be here today if it wasn’t for keto.”
• “I can tell you that I have never felt better than I have since using ketosis.”

“After we witnessed ketogenic therapy send our son’s ‘treatment resistant’ bipolar disorder into complete and lasting remission, we immediately started funding metabolic psychiatry studies like Dr. Sethi’s,” said Jan Ellison Baszucki, co-founder and President of Baszucki Group. “This pilot study, the first of its kind, offers hope to those living with bipolar illness, and has successfully paved the way for larger trials that could establish ketogenic therapy as a safe and effective adjunctive or even first-line treatment for bipolar disorder and other serious mental illnesses.”

Based on the results of Dr. Sethi’s study, along with preliminary data from a University of Edinburgh trial, Baszucki Group has followed its pilot trial grants with the establishment of a new global funding program: ReThink Bipolar: Researching Therapeutic Integration of Nutritional Ketosis in Bipolar Disorder. To date, the program has announced $8M in funding to McLean Hospital and the University of Pittsburgh for randomized controlled trials combining mechanistic explorations with a clinical ketogenic intervention. In addition, Baszucki Group’s initiative, MetabolicMind.org, amplifies research and personal stories and provides free resources for patients, families and clinicians adopting metabolic therapies to improve mental health.