Ketogenic therapy for mental health conditions

When countless people are suffering and lives are at stake, why invest time and money in Randomized Controlled Trials?

Updated 10/5/2023

During a question and answer session with panelists at the Metabolic Psychiatry: Lived Experience and Patient-Centered Research Dinner hosted by the Baszucki Group at the 8th Global Symposium on Ketogenic Therapies, a neurologist and laboratory scientist who works on metabolism posed a provocative question. Perhaps purposefully playing devil’s advocate, he chuckled and admitted that he was “causing problems.” While suggesting that he believes in ketogenic therapy for mental illness, he questioned the need for Randomized Controlled Trials (RCTs) when pilot trials and numerous patient testimonials already indicate efficacy. RCTs are considered a gold standard in research methodology; they are rigorously designed and utilize randomization and control groups to determine the causal relationship between an intervention and its effects. 

As an early adopter of ketogenic therapies who put my bipolar 1 disorder into remission, I had to ponder the question for a moment. I started before RCTs, before pilot trials—before I could even find a competent clinician to help me. I am so glad I did not wait. It is impossible to say how many years or even decades it might take for metabolic therapies to become mainstream. When I started with almost no support and very few resources in the summer of 2021, I was desperate and simply unwilling to lose even one more year of my precious life to the crippling side effects of antipsychotics. Looking around the room, I thought how novel it was to be at an event where I was one of five individuals in recovery following a devastating bipolar diagnosis, currently living a happy, healthy life thanks to metabolic therapies. 

Undoubtedly, our current treatments are failing far too many people. The outcomes for those diagnosed with bipolar disorder are particularly dismal. Panelist Dr. Iain Campbell, Baszucki Brain Research Fellow in Metabolic Psychiatry at the University of Edinburgh, has a viewpoint that is enriched through his lived experience as someone in remission from bipolar 2 disorder. He referenced a troubling statistic: up to 60% of people with a bipolar diagnosis attempt suicide at least once in their lives. During the depths of his depression, it was a “serious mental task,” he said, just to stop himself from jumping off of the balcony of his fifth-floor flat. After experiencing ketosis for the first time, he felt like the “lights went on” in his head: “It was the first time I ever experienced what it is was like to be normal or functional. And this was a complete revelation to me, and I knew I would spend the rest of my life trying to understand this.”

MJ Leman, an entrepreneur, also shared his lived experience with bipolar 1 disorder as a panelist, describing how traditional treatments helped him control mania, but left him feeling depressed at least 25% of the time. He said the impact of ketogenic therapy was “truly extraordinary” and “really did eradicate the symptoms of bipolar disorder” for him. 

The panel, moderated by Dr. Bret Scher, director of Metabolic Mind, also included Dr. Shebani Sethi, founding director of the first academic Metabolic Psychiatry clinical program at Stanford University, and Nicole Laurent, a licensed mental health counselor who helps clients transition to a ketogenic diet. I leaned forward, listening closely. Knowing firsthand the urgency many people feel in the face of treatments that are often ineffective and wrought with unwanted, life-diminishing side effects, I was curious to see how the panelists would respond to such a challenging question.

The Global Symposium on Ketogenic Therapies, a biennial event traditionally centered on the therapeutic use of the ketogenic diet for epilepsy, spotlighted the emerging field of Metabolic Psychiatry for the first time this year. Many of the clinicians in attendance expressed enthusiasm for the burgeoning expansion of ketogenic therapy into the mental health field. Sethi and Campbell recently finished pilot trials to measure the efficacy of ketogenic therapy for severe mental illness; both showed extremely promising results. The rapidly growing number of case reports and anecdotal success stories also strongly indicate that metabolic therapies can be game-changing for numerous patients.

Surprisingly, the first reply came from Laurent, who humbly interjected that she should not be the one answering as a non-researcher. Her compassion as a counselor shone through in her insightful answer, “I see people suffer for decades unnecessarily because this (ketogenic therapy) is not standard of care. If these brilliant researchers need to jump through all the hoops to make this available to people as a first option, then I think, whatever it takes.” Standard of care options are treatments that are recognized and recommended as safe, effective, evidence-based approaches according to research and clinical guidelines. Sethi agreed with Laurent, adding that RCTs will also play a critical role in ensuring these treatments can be reimbursed by payers, making them an economically viable option for clinicians and patients. 

Campbell shared that RCTs have historically helped guide us out of the “dark ages of psychiatry,” citing horrific treatments including insulin shock therapy and lobotomies that scientific evidence eventually ousted. RCTs provide evidence that patients and families can point to as they fight for more humane treatments with better outcomes. 

It is not surprising that it is often the patients and families proactively driving scientific innovation in the fight for better care. David Baszucki and Jan Ellison Baszucki were inspired after helping their son Matt implement metabolic therapies to put his bipolar 1 disorder into remission. They are catalyzing change by funding science, including RCTs, through the Baszucki Group and, simultaneously, providing immediate support through grassroots advocacy. They founded Metabolic Mind, an incredible nonprofit initiative that provides invaluable resources to patients and families exploring the option of metabolic therapies.

The number of ketogenic therapy success stories is growing exponentially. I am grateful to be enjoying life and thriving again; the almond slivers on my salad, to use a lifestyle-appropriate idiom for someone on a vegetarian keto diet, is belonging to a community of others with lived experience, working hand-in-hand with researchers and clinicians at the forefront of a movement to make these comprehensive and effective treatments more accessible. While not a panacea, ketogenic therapy can be a cornerstone intervention that allows many people with severe mental illness to treat the root cause of their condition and experience an astonishing, almost unbelievable transformation.

In addition to the grassroots efforts fueling a growing number of patient testimonials and case studies, RCTs are absolutely critical if we want to create systemic change and establish these treatments as a standard of care, first-line option in the future. Supporting RCTs and providing patient and family advocacy and resources are not mutually exclusive tactics: they are complementary and will promote a positive feedback loop when done in tandem. While we need more evidence-based science supporting metabolic therapies, we must simultaneously acknowledge that many individuals can’t afford to wait for it. Time is of the essence.