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Foundational
Clinical Trials

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.

First European Trial Shows Promise of Keto as a New Treatment for Bipolar

Clinical Trial

First European Trial Shows Promise of Keto as a New Treatment for Bipolar

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.

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Stanford Study Shows Keto Improves Symptoms of Serious Mental Illness

Clinical Trial

Stanford Study Shows Keto Improves Symptoms of Serious Mental Illness

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.

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Case Series and Pilot Projects

Retroactive 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.

Ketogenic Diet for Refractory Mental Illness: A Retrospective Analysis of 31 Inpatients

Retrospective Analysis

Ketogenic Diet for Refractory Mental Illness: A Retrospective Analysis of 31 Inpatients

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.

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Modified Ketogenic Diet and Ketamine for Anorexia Nervosa

Modified Ketogenic Diet and Ketamine for Anorexia Nervosa

A 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.)

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Animal-Based Ketogenic Diet Puts Severe Anorexia Nervosa into Multi-Year Remission: A Case Series

Animal-Based Ketogenic Diet Puts Severe Anorexia Nervosa into Multi-Year Remission: A Case Series

Researchers 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.)

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Complete Remission of Depression and Anxiety Using a Ketogenic Diet: Case Series

Complete Remission of Depression and Anxiety Using a Ketogenic Diet: Case Series

A 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.)

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Remission of OCD and Ulcerative Colitis With A Ketogenic Diet: Case Report

Remission of OCD and Ulcerative Colitis With A Ketogenic Diet: Case Report

A 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)

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Ketogenic Metabolic Therapy For Schizoaffective Disorder: A Retrospective Case Series of Psychotic Symptom Remission and Mood Recovery

Ketogenic Metabolic Therapy For Schizoaffective Disorder: A Retrospective Case Series of Psychotic Symptom Remission and Mood Recovery

A case series of two individuals who experienced full remission of psychotic and mood symptoms after implementing ketogenic metabolic therapy. (Nicole Laurent, LMHC, et al.)

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Retrospective Case Study: Ketogenic Metabolic Therapy in the Effective Management of Treatment-Resistant Depressive Symptoms in Bipolar Disorder

Retrospective Case Study: Ketogenic Metabolic Therapy in the Effective Management of Treatment-Resistant Depressive Symptoms in Bipolar Disorder

A 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)

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Ketogenic Diet as a Therapeutic Intervention for Obsessive-Compulsive Disorder: A Case Series of Three Patients

Ketogenic Diet as a Therapeutic Intervention for Obsessive-Compulsive Disorder: A Case Series of Three Patients

A 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)

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Ketogenic Diet in the Treatment of Schizoaffective Disorder: Two Case Studies

Ketogenic Diet in the Treatment of Schizoaffective Disorder: Two Case Studies

A 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)

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The Ketogenic Diet and Remission of Psychotic Symptoms in Schizophrenia: Two Case Studies

The Ketogenic Diet and Remission of Psychotic Symptoms in Schizophrenia: Two Case Studies

A 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.)

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Clinical Trials

Results of the first completed clinical trials of a ketogenic diet in serious mental illness since the 1960’s are now emerging.

More than a dozen clinical trials of ketogenic therapy for serious mental illness are now completed or underway for conditions that include major depression, schizophrenia spectrum disorder, bipolar disorder, and anorexia.

Additional trials not listed here are in process for many other brain-based disorders, including anxiety, Alzheimer’s disease, autism, post-traumatic stress disorder, and alcohol use disorder.

By diagnosis

Active

Ketogenic Diet Intervention in Schizophrenia, Bipolar Disorder, Major Depressive Disorder: Deep Omic Profiling

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
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Active

Child Bipolar Network Ketogenic Diet Approach to Bipolar Disorder in Adolescents (CBN Keto)

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
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Active

Ketogenic Diet for Depression (KETO-MOOD)

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
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Completed

Ketogenic Diet for Treatment-Resistant Depression: Dietary Interventions for Mental Health Study

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
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Active

Examining Neurobiological Mechanisms Underlying the Therapeutic Effect of the Ketogenic Diet in Bipolar Disorder (BD)

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
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Active

Therapeutic Ketogenic Diet in Anorexia Nervosa

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
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Completed

Ketogenic Intervention in Depression (KIND)

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
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Active

Ketogenic Diet Therapy Major Depressive Disorder (KETOMDD)

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
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Active

The Effects of Diet on Metabolic and Mental Health Outcome Measures in Bipolar Disorder and Schizophrenia: A Randomized Controlled Clinical Trial

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
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Active

Ketogenic Diet in People With Schizophrenia

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
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Active

Ketogenic Diet for Psychotic Disorders (PsyDiet)

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
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Completed

Impact of a Ketogenic Diet on Metabolic and Psychiatric Health in Bipolar or Schizophrenia Illness

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
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Completed

Pilot Study for Phase 2 Clinical Trial and Mechanistic Study of Ketogenic Diet in Bipolar Disorder

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
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Completed

Modified Ketogenic Diet and Ketamine for Anorexia Nervosa

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
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Active

Ketogenic and Nutritional Interventions for First Episode Bipolar Disorder

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
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Active

Can Neural Network Instability in Schizophrenia be Improved With a Very Low Carbohydrate Ketogenic Diet?

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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Research Videos

33:49

Metabolic Therapies for Psychiatry: State of the Evidence