New Results: First RCT for Schizophrenia & Bipolar Disorder. Learn more.
Trials of ketogenic therapy for serious mental illness are being conducted around the world for a variety of diagnoses, including major depression, schizophrenia spectrum disorder, bipolar disorder, and anorexia. Explore this database to participate in active studies and discover the science behind metabolic psychiatry.
Note: Trial statuses are updated regularly but may differ from those on the official study websites.
Treatment-resistant depression occurs when depressive symptoms persist despite standard therapies. Intermittent theta burst stimulation (iTBS) is an FDA-approved therapy designed to reduce depressive symptoms by stimulating brain activity. This clinical trial tests whether combining a ketogenic diet with accelerated, personalized iTBS further reduces depressive symptoms and is feasible for patients to follow successfully.
| Diagnosis | Depression |
| Principal Investigator | Sean Nestor, MD, PhD |
| Institution | Sunnybrook Health Sciences Centre |
| Location | Toronto, Canada |
This study will test an online group ketogenic metabolic therapy program for people with depression and anxiety, measuring its impact on mental health outcomes. The fully remote model combines education with sustained professional and peer support, designed for integration into existing clinical care.
| Diagnosis | Anxiety, Depression |
| Principal Investigator | Erin Louise Bellamy, PhD |
| Institution | University of East London |
| Location | United Kingdom |
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 | Depression, Schizophrenia, Bipolar Disorder |
| 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 | Depression, Bipolar Disorder |
| Principal Investigator | Timur Liwinski, MD |
| Institution | University Psychiatric Clinics Basel |
| Location | Basel, Switzerland |
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 |
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 |
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 |
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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