McLean Hospital Launches Clinical Trial of Ketogenic Therapy for Bipolar Disorder

February 15, 2024 — Today, Baszucki Group announced the launch of a new partnership with McLean Hospital in Belmont, MA, on a clinical trial of a therapeutic ketogenic diet for bipolar disorder. A cross-disciplinary team at McLean’s early psychosis program will investigate nutritional ketosis as both a novel treatment strategy and a critical tool for understanding the underlying mechanisms of bipolar disorder. The new effort builds on decades of groundbreaking science implicating disordered metabolism as a key driver of psychiatric illnesses like bipolar disorder. The grant provides support to pioneering McLean scientists with a track record of studying neurometabolism in psychiatric illness, and aims to provide additional scientific rationale for a recent breakthrough in clinical care that is already saving lives worldwide. Ranked as the #1 Psychiatry Hospital by US News in 2024, McLean is a teaching hospital of Harvard Medical School and a member of Mass General Brigham.

“We are thrilled to partner with one of the leading psychiatric hospitals in the world on this important new therapeutic approach to treating bipolar disorder that gave our son his life back,” said Jan Ellison Baszucki, co-founder and President of Baszucki Group. “These grants will not only foster an understanding of the metabolic roots of bipolar disorder, but will generate new evidence and clinical perspectives on ketogenic therapy, the intervention our family first learned about from McLean psychiatrist and author of Brain Energy, Dr. Chris Palmer.”

The clinical trial will be led by Dr. Virginie-Anne Chouinard, staff psychiatrist and director of research at McLean OnTrack™, a program for first episode psychosis at McLean Hospital, and an instructor in psychiatry at Harvard Medical School. The study will enroll fifty participants with early bipolar disorder in an outpatient, randomized controlled trial to assess various multimodal neuroimaging markers and metabolic measures. It will assess the impact of a ketogenic diet on energy metabolism, oxidative stress, neurometabolic markers, insulin resistance, and psychotic and mood symptoms with the goal of improving the treatment trajectory of individuals with early phase bipolar disorder. Patient recruitment information can be found on ClinicalTrials.gov.

“Our group has spent over a decade studying the metabolic pathways implicated in psychiatric disorders, especially in the context of early intervention for psychotic illness,” said Dr. Dost Öngür, William P. and Henry B. Test Professor of Psychiatry, Chief of the Division of Psychotic Disorders, and Director of the Schizophrenia and Bipolar Disorder Research Program at McLean Hospital. “This study is deeply synergistic with our increasing focus on the intersection of metabolic and mental health here at McLean Hospital. Groundbreaking research is leading to advancements in clinical care for psychiatric conditions.”  

The $2 million gift to McLean Hospital is the first grant in Baszucki Group’s new research program: ReThink Bipolar: Researching Therapeutic Integration of Nutritional Ketosis in Bipolar Disorder. ReThink Bipolar builds on Baszucki Group’s prior investments in bipolar disorder therapeutic research, as well as six pilot trials of ketogenic therapy for serious mental illness, including bipolar disorder, schizophrenia, major depression and anorexia nervosa.