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The first prospective clinical pilot trials of ketogenic diet for serious mental illness since 1965 have recently been published in peer-reviewed scientific journals. The results demonstrate the safety and feasibility of ketogenic interventions in this population, along with promising improvements in both metabolic and mental health. The early pilot data provide a strong foundation for larger randomized controlled trials for a variety of diagnoses. Several additional trials have been completed and are nearing publication.
Clinical Trial
European pilot trial at the University of Edinburgh proved a ketogenic diet was safe and effective for bipolar disorder, leading to improvements in mood, energy, and anxiety, along with weight loss and lower blood pressure. The landmark keto study fuels hope for a new treatment for bipolar disorder.
Learn MoreClinical Trial
April, 2024. New findings of a pioneering Stanford pilot study published in Psychiatry Research show dramatic improvements in psychiatric and metabolic outcomes in bipolar disorder and schizophrenia.
Learn MoreRetroactive analyses of inpatient and outpatient cases in which ketogenic therapy was used for serious mental illnesses are accumulating in the scientific literature, including thirty-one patients with refractory illness in France. This form of evidence is critical for encouraging investment in additional research trials across psychiatric diagnoses.
Retrospective Analysis
Dr. Albert Danan showed that in a French cohort of treatment-resistant inpatients, all experienced weight loss and psychiatric symptom reduction, with nearly half no longer meeting criteria for mental illness after treatment.
Learn MoreA small pilot trial of five patients demonstrated safety and efficacy for adults with chronic anorexia nervosa psychopathology and supports specific neurobiological mechanisms that can be normalized using therapeutic ketogenic diet and ketamine. (Lori Calabrese, MD, et al.)
Learn MoreResearchers at Harvard published this case series, suggesting a ketogenic diet may be useful for some patients with anorexia nervosa. (Nick Norwitz, MD, PhD, et al.)
Learn MoreA case series of three adults who achieve complete remission of major depression and generalized anxiety disorder with a ketogenic dietary intervention. (Lori Calabrese, MD, et al.)
Learn MoreA case study describing the first clinical application of a ketogenic diet in adult OCD with ulcerative colitis (UC) resulting in complete remission of OCD, clinical remission of UC, and improved metabolic health. (Lori Calabrese, MD)
Learn MoreA case series of two individuals who experienced full remission of psychotic and mood symptoms after implementing ketogenic metabolic therapy. (Nicole Laurent, LMHC, et al.)
Learn MoreA case study about how ketogenic therapy improved treatment-resistant depressive symptoms in a patient with bipolar disorder, leading to a stabilized mood, enhanced quality of life, and reduced medication dependence. (Nicole Laurent, LMHC)
Learn MoreA case series of three individuals with obsessive-compulsive disorder (OCD) who achieve medication-free remission and a 90.5% reduction in symptoms after adopting a ketogenic diet. (Aaron MacDonald & Chris Palmer, MD)
Learn MoreA case series of two individuals with schizoaffective disorder who experienced significant reductions in symptoms during ketosis, with symptoms returning when out of ketosis and resolving again upon re-entering ketosis. (Chris Palmer, MD)
Learn MoreA case series of two individuals with schizophrenia who achieved long-term, medication-free remission of psychotic symptoms after adopting a ketogenic diet. (Chris Palmer, MD, et al.)
Learn MoreResults of the first completed clinical trials of a ketogenic diet in serious mental illness since the 1960’s are now emerging.
By diagnosis
Serious mental illnesses like schizophrenia, bipolar disorder, and major depression affect hundreds of millions of people and are often linked to metabolic issues, reducing life expectancy. This randomized clinical trial (RCT) will study whether a ketogenic diet, which improves brain energy use and metabolism, can enhance quality of life and mental health outcomes for individuals with these conditions.
Diagnosis | Bipolar Disorder, Schizophrenia, Depression |
Principal Investigator | Shebani Sethi, MD |
Institution | Stanford University |
Location | Palo Alto, California |
This trial investigates the use of keto diets for adolescents and young adults (ages 12-21 yrs) in the depressive or mixed phases of bipolar disorder (BD). Investigators across four study sites (UCLA, U Cincinnati, U Colorado and U Pittsburgh) aim to determine if combining standard of care pharmacological treatment for bipolar disorder with a 16-week keto diet is well-tolerated and associated with improvements in depression, inflammatory and metabolic indicators, and executive functioning.
Diagnosis | Bipolar Disorder |
Principal Investigator | David J. Miklowitz, Ph.D. |
Institution | University of California, Los Angeles |
Location | Los Angeles, California |
With depression affecting 300 million people globally and long-term recovery proving difficult, this study explores whether a ketogenic diet can alleviate depressive symptoms compared to a standard diet.
Diagnosis | Bipolar Disorder, Depression |
Principal Investigator | Timur Liwinski, MD |
Institution | University Psychiatric Clinics Basel |
Location | Basel, Switzerland |
1 in 6 adults in the UK live with depression, and current treatments and medications aren’t working for everyone. This study investigates the use of a ketogenic diet as an additional intervention for individuals with treatment-resistant depression.
Diagnosis | Depression |
Principal Investigator | Megan Kirk Chang, PhD, Min Gao, PhD |
Institution | University of Oxford |
Location | Oxford, United Kingdom |
People with bipolar disorder often experience mania/hypomania. This study examines the impact of a ketogenic diet on periods of mania/hypomania in individuals with bipolar disorder.
Diagnosis | Bipolar Disorder |
Principal Investigator | Mary Phillips, MD |
Institution | University of Pittsburgh |
Location | Pittsburgh, Pennsylvania |
In a previous study, patients with anorexia nervosa showed improvements on a ketogenic diet. This study investigates the impact of a therapeutic ketogenic diet on individuals with anorexia nervosa who have been weight normalized.
Diagnosis | Anorexia Nervosa |
Principal Investigator | Guido Frank, MD |
Institution | University of California at San Diego (UCSD) |
Location | San Diego, California |
In recent years, there has been an increase in major depression in young adults, particularly on college campuses. This study aims to examine if a ketogenic diet can be implemented in a university counseling setting and its impact on affected individuals.
Diagnosis | Depression |
Principal Investigator | Jeff Volek, PhD |
Institution | The Ohio State University |
Location | Columbus, Ohio |
Some people do not respond to first-line medications for depression such as SSRIs. This study investigates the effectiveness and feasibility of a ketogenic diet for individuals with depression.
Diagnosis | Depression |
Principal Investigator | Elisa Brietzke, MD, PhD |
Institution | Queen's University |
Location | Ontario, Canada |
This study looks at the impact of dietary intervention alongside treatment in patients with a diagnosis of bipolar disorder, schizophrenia or schizoaffective disorder.
Diagnosis | Schizophrenia, Bipolar Disorder |
Principal Investigator | Calogero Longhitano, MD & Zoltan Sarnyai, MD, PhD |
Institution | James Cook University |
Location | Queensland, Australia |
A ketogenic diet shows promise for treating schizophrenia and schizoaffective disorder. This study will evaluate the effects of a ketogenic diet on schizophrenia and schizoaffective disorder in an inpatient setting.
Diagnosis | Schizophrenia, Schizoaffective disorder |
Principal Investigator | Deanna Kelly, PharmD |
Institution | University of Maryland, Baltimore |
Location | Cantonsville, Maryland |
Some people diagnosed with psychotic disorders have trouble using sugar as energy for their brain. This study investigates the impact of a ketogenic diet on depression and anxiety and psychotic symptoms such as delusions. Additionally, the study investigates the feasibility of a ketogenic diet in an inpatient setting.
Diagnosis | Psychotic Symptoms |
Principal Investigator | Anu Ruusunen, PhD |
Institution | Kuopio University Hospital |
Location | Kuopio, Finland |
Dr. Shebani Sethi’s 4-month clinical trial at Stanford of ketogenic diet for serious mental illness showed promising preliminary results indicating remission of bipolar disorder and schizophrenia in participants who adhered to the diet, as well as reversal of metabolic syndrome for those with the diagnosis
Diagnosis | Bipolar Disorder, Schizophrenia |
Principal Investigator | Shebani Sethi, MD |
Institution | Stanford University |
Location | Stanford, California |
In this study, Drs. Daniel Smith, Nicole Needham, Iain Campbell and colleagues at University of Edinburgh demonstrated the safety and efficacy of using ketogenic therapy in bipolar disorder.
Diagnosis | Bipolar Disorder |
Principal Investigator | Daniel Smith, MD |
Institution | University of Edinburgh |
Location | Scotland |
A small pilot trial demonstrated safety and efficacy for adults with chronic psychopathology and supports specific neurobiological mechanisms that can be normalized using therapeutic ketogenic diet and ketamine.
Diagnosis | Anorexia Nervosa |
Principal Investigator | Lori Calabrese, MD |
Location | South Windsor, Connecticut |
Early intervention is important in the recovery process after the first episode of psychosis. This study examines the effects of a ketogenic intervention on energy metabolism and psychiatric symptoms in individuals with first episode bipolar disorder or schizoaffective disorder.
Diagnosis | Bipolar Disorder, Schizoaffective disorder |
Principal Investigator | Virginie-Anne Chouinard, MD & Dost Öngür, MD, PhD |
Institution | McLean Hospital |
Location | Belmont, Massachusetts |
Those with schizophrenia, schizoaffective disorder and/or bipolar disorder may have a harder time using glucose for brain energy. This study investigates if a ketogenic diet improves neural network stability and cognitive functioning.
Diagnosis | Bipolar Disorder, Schizophrenia, Schizoaffective disorder |
Principal Investigator | Judith Ford, PhD |
Institution | University of California at San Francisco (UCSF) |
Location | San Francisco, California |
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Metabolic Therapies for Psychiatry: State of the Evidence