Ketogenic Diet for Mental Illnesses

Recruiting in Palo Alto (17 mi)

Overseen ByShebani Sethi, MD, ABOM

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Stanford University

No Placebo Group

Trial Summary

What is the purpose of this trial?The goal of this randomized clinical trial is to be adequately powered to evaluate the effect of ketogenic metabolic therapy on the quality of life in serious mental illness, schizophrenia, bipolar disorder, major depressive disorder.

Eligibility Criteria

This trial is for U.S. residents with schizophrenia, bipolar disorder, or major depressive disorder who are clinically stable and not hospitalized in the past 3 months. They must have a moderate to severe condition score (PHQ-9 >10 or BPRS >40) and can be on stable psychiatric medication. Excluded are those with certain medical conditions, substance abuse issues, recent ketogenic dieting, or participation in other trials.

Inclusion Criteria

I have been diagnosed with bipolar disorder, major depressive disorder, or schizophrenia.

My depression is moderate to severe, stable, and I haven't been hospitalized recently.

Exclusion Criteria

I have a family history of very high cholesterol.

I have severe kidney or liver problems.

I have not been in a clinical trial with investigational drugs that could affect this study in the last month.

I use insulin for my diabetes.

I have been hospitalized or taken clozapine at doses above 550mg in the last 3 months.

I do not have heart problems like heart failure, chest pain, irregular heartbeat, or valve issues.

I cannot complete initial health measurements.

Participant Groups

The study compares the effects of a Low-Carbohydrate High-Fat (LCHF) Ketogenic Diet versus a standard Diet-as-Usual (DAU) on quality of life in patients with serious mental illnesses like schizophrenia and bipolar disorder. It's randomized to determine if this dietary intervention can improve health outcomes.

2Treatment groups

Experimental Treatment

Group I: Arm 2: DAU- Ketogenic Diet CrossoverExperimental Treatment2 Interventions

Participants will follow 12 weeks of their usual diet (Diet-as-Usual, DAU). Then, participants will crossover and follow 12 weeks of the ketogenic diet. Monitoring of physical and psychological health and coaching support will occur throughout participation.

Group II: Arm 1: Ketogenic Diet OnlyExperimental Treatment1 Intervention

Participants will follow 12 weeks of the ketogenic diet, with monitoring of physical and psychological health and coaching support.