Info: Ketogenic Therapy Pilot Study Results

CMHRC's Ketogenic Therapy Pilot Study Results

From October 2024 until July 2025 CMHRC conducted a pilot research study on the effects of ketogenic therapy in children living with bipolar disorder. Through a comprehensive program of support and psychoeducation families implemented ketogenic therapy and experienced improvements in symptom intensity and frequency, and found their quality of life improve overall. Below are the preliminary results from this pilot study. Case study papers are forthcoming.

What Is Ketogenic Therapy?

Ketogenic therapy is a way of eating that creates ketones, which the body and brain use as a plentiful energy source to replace glucose. Ketones are an important energy source for the body and your brain can run on both glucose and ketones. In actuality, ketones can be a more efficient fuel source than glucose, reducing inflammation, and reducing oxidative stress in the brain. While the brain and body do also need glucose, it doesn’t actually have to come from the food you eat. The body can make the glucose it needs by converting the protein and fat you consume.

It’s not a diet, its purpose is not for weight loss, weight gain, or muscle building or any of the other things that you may have seen online with the popularity of high protein/ low-carb diets. Ketogenic therapy is a high fat food plan that is balanced with protein and has limited carbohydrates to create those ketones. The purpose of ketogenic therapy is to achieve and maintain a state of medical and or nutritional ketosis in order to reduce the presence, frequency, and severity of symptoms of mental or physical illness.

Ketogenic Therapy's Beginnings

In 1921, Dr. Russell Wilder at the Mayo Clinic, developed what he called the ketogenic diet as a nutritional treatment for epilepsy that would mimic fasting by producing ketones to be used for energy in the brain. This new therapeutic model wound up reducing seizure frequency by about 50% or more in epilepsy patients, 30% or more of whom went on to have no additional seizures for the remainder of their life, even after stopping the therapy.

Applications of ketogenic therapy evolved and in the past 15 years research has begun to focus on its use in treating mental illness. Disorders that have been studied include schizophrenia and schizoaffective disorder, bipolar disorders, major depression, and anxiety.

In 2024, the publication of a landmark study by Dr. Shebani Sethi at Stanford Medical School examined the use of ketogenic therapy as a metabolic treatment for adult patients with schizophrenia and bipolar disorder. This study has caused quite a stir because of the significant findings that the therapy meaningfully reduces symptoms.

The Study's Goals

Our ketogenic therapy study had two different purposes. The first was to examine the impact of ketogenic therapy on symptoms of pediatric bipolar disorder and related quality of life issues. The second was to identify what support a family needs in order to successfully adopt and maintain ketogenic therapy. Families living with mental illness need additional supports to implement lifestyle interventions in part because of the 10- year treatment onset delay, in part because they often live with social isolation stemming from stigma associated with mental illness, and in part because they live in a system where juvenile onset bipolar disorder is under-recognized and undertreated.

Why Pediatric Bipolar?

More than 1 million children in adolescents are diagnosed with pediatric bipolar disorder in the United States. However, National Institute of Mental Health research estimates report that nearly ⅓ of the 3.4 million children and adolescents who are diagnosed with major depression in the US are actually misdiagnosed, and that they actually have early onset bipolar disorder, which means that that is another million plus children and teens who do not have an accurate diagnosis.

The pervasive and pernicious misconception that children can not have or be diagnosed with bipolar disorder means that millions of children don’t get accurately diagnosed until they’re 18, 19, 20 years old or even further into adulthood. This has dire consequences for this community. Estimates suggest that as many as 60% of people with bipolar disorder, at some point, attempt to end their lives, which makes polar disorder a threat to their very survival.

Additionally, up to 38.9% of the entire pediatric population have metabolic dysfunction. This is especially concerning for children with mental health conditions because the antipsychotic medications they are frequently prescribed can cause metabolic dysfunction. Unfortunately, these antipsychotics are often given to pediatric patients instead of gold standard treatment medications like mood stabilizers.

Study Design

The subjects in our study who met the completion criteria, spent four weeks transitioning into a ketogenic food plan and spent 20 weeks adhering to that food plan. Their individual macro ratios ranged from a low as .75:1 to 2:1. Each day they tracked what they ate, their ketone and glucose levels as well as details on their symptom severity. Each month they completed assessments evaluating the presence of depressive symptoms, manic symptoms, aggressive symptoms, sleep disruptions, and obsessive compulsive symptoms. With them we created a virtual community, moderated by professionals, but providing a space for peer-to-peer support. We also provided ongoing weekly group virtual face-to-face sessions with psychoeducation about ketogenic therapy and group support. It was in this context that we carried out our study.

Results

On validated measures of five symptoms common in pediatric bipolar 100% of subjects who met the completion criteria showed meaningful improvement. I’m going to say that again so that we all appreciate how remarkable this is. 100% of the subjects who followed the protocol saw improvement.

The two main symptom categories in bipolar are of course, depression and mania. And as rated on the Beck Depression Inventory and the Young Mania Rating Scale, both sets of symptoms dropped an average of 76% averages in aggression dropped by 58%. Sleep disruptions decreased by an average 51% and obsessive compulsive scores decreased by 42%. Importantly, all five measures showed statistical, what we call statistical significance with the Beck and obsessive compulsive scales, both having p values less than 0.05, meaning that there is less than a 5% chance that these results happened by chance. The overt aggression scale, Pittsburgh Sleep Quality Index, and Young Mania Rating Scale had p values less than 0.01, meaning that there is a less than 1% chance the results were a fluke, suggesting strong evidence that the observed effect is real. This is incredibly compelling evidence for researchers for families.

Preliminary qualitative data showed us that ketogenic therapy is, in fact, feasible for families to follow when they are given the right amount of support. Part of what made ketogenic therapy sustainable through our specific study was the community aspect that was so heavily woven into the process.

Ketogenic therapy adoption and adherence is eased with frequent and sustained contact with, and support from, experts as well as having a strong peer community.

Case Study

This child’s symptoms onset at age four and was diagnosed with bipolar disorder cyclothymia. This child was denied access to the gold standard bipolar disorder treatment, which is lithium or another mood stabilizer. They had to endure two failed ADHD medication trials. Worse, the only medications that family were given as options from their prescriber were those ADHD medications and SSRI antidepressants, both of which are contraindicated in bipolar disorder treatment, and antipsychotic medications which can have devastating metabolic effects. The prognosis for a child in these circumstances is, generally speaking, not good. But after adopting ketogenic therapy, the changes were staggering.

This subject experienced a

complete elimination of both depressive and obsessive compulsive symptoms. They had a 90% reduction in both manic symptoms and chronic sleep disruptions. 84% reductions in parent reported symptom intensity and frequency, and 62% reductions in aggression (which is a common feature in pediatric bipolar disorder).

We found that the younger the child, the more easily they adapted to the food plan and the lower the macro ratios were that were required to reach higher ketone levels. But regardless of age, the children connected ketogenic therapy to feeling better. So once in ketosis, they had intrinsic motivation to stay on plan. This subject continued with ketogenic therapy after the study ended and at bedtime asks for the “good dreams” fat bomb, which is the only thing that has ever stopped this child’s nightmares.

Ketosis and Community

We’ve seen that therapeutic levels of ketosis ease symptoms and improve quality of life for children with bipolar.

But achieving and maintaining therapeutic levels of ketosis requires more than just being given information on keto guidelines.

Success requires frequent and sustained contact with both the experts guiding them, and with a strong peer community to help families navigate the unexpected and unavoidable obstacles that occur along the way, and to break down their isolation, caused by persistent stigma against mental illness.

The most powerful tool we have to ensure positive long term outcomes in mental illness is early intervention, and ketogenic therapy is one of the most promising early intervention tools we have, helping children avoid traumatic hospitalizations, unnecessary or contraindicated medication trials and their side effects. What we’ve seen, is that it is the combination of ketosis and community that has brought hope to families who’ve had nowhere else to turn for far too long.

Participant Testimonials

“This study has changed the quality of life available for my child and our family. We have seen a significant decrease in symptoms, but more we have seen the light come back to our child’s eyes and we have seen them begin to actually play again. This study has unlocked the cage that has been holding my child hostage and allowed them to be free again.”

“My child’s improvements have been significant and while they’re not ‘cured’ per se, the impacts of those improvements are far-reaching. For example, it has allowed us to plan things like a family vacation where everyone gets to come. That seems like a little thing that is huge for our family.”

“The community and psychoeducation were crucial to our success, but it took me a while to realize how valuable it was. I was too confident about our ability to catch on and be successful. I thought we wouldn’t need to rely on the group because we would understand the guidelines and apply them in a way that fit our life. But, it actually requires a lot of diligence, I couldn’t just ‘wing it.’ Thank goodness the team and the other participants were there to help us get on track and stay there.”

“Having designated time each week to focus and connect with my keto cohort has been the fuel that keeps me successful in engaging my child in ketogenic therapy. The dedicated support and psychoeducation was tailored perfectly to funnel us the information in bite-size chunks that did not feel overwhelming. Now that we are more acclimated, the sessions are tailored to our needs, not only feeding us the education for continued success, but building our confidence for life-long skills. Doing this in a vacuum, without the incredible knowledge of our team would be difficult, but without the encouragement and connection of the others in the cohort feels nearly impossible at this point.”

“Day to day life was sneaked conversations away from earshot, hiding knives, covering our ears, utter exhaustion, angry attacks: a hostage situation for me, siblings, and our pets. Thankfully, we hit ketosis early and stayed in it for 99% of the study. Our lives have changed dramatically. The child I mourned is not in fact dead after all. Who my child was before the onset is still all there, and with each passing day returns. They are self aware and can express their mental state accurately and are able to help themself as much as a young person can. My child asks about the research and trusts/appreciates that mental health is a team effort for now, but that they will ultimately be in charge of their own health and that choices are important.”

“CMHRC is a phenomenal resource for parents like me, and their support throughout this study has been irreplaceable. The return on this investment in the life of my child, my family’s lives, and the lives of the other families supported by CMHRC is, in my opinion, several magnitudes greater than the equivalent in the field of conventional (pharmaceutical-based) pediatric psychiatry. CMHRC even supported our families by educating our circles of support (extended family and friends) as well.”

Our Sponsor

We are grateful to Baszucki Group for their support and commitment to championing the potential of metabolic therapies. We also deeply appreciate their recognition of CMHRC’s as an organization that can carry out this study while providing resources, support, and guidance to families. This significant funding allows us to further our mission to provide vital support and resources to children and families facing mental illness.