Ketogenic Diet for Schizophrenia

Overseen By Matthew Glassman, MS

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Maryland, Baltimore

Must be taking: Antipsychotics

Disqualifiers: Pregnancy, Diabetes, Heart failure, others

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

50 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing if a special high-fat, low-carb diet can help people with schizophrenia who don't get better with regular medications. The diet changes how the body gets energy, which might improve brain function and reduce symptoms. The ketogenic diet has shown benefits in epilepsy and other neurological conditions, suggesting it may also help with psychiatric conditions.

Do I need to stop my current medications for this trial?

The trial does not specify if you need to stop your current medications. However, it requires that your antipsychotic medication dose has not changed in the last 14 days, suggesting you may continue your current regimen.

What evidence supports the effectiveness of the ketogenic diet as a treatment for schizophrenia?

Research suggests that a ketogenic diet, which is high in fats and low in carbohydrates, may help improve symptoms of schizophrenia by providing an alternative energy source for the brain and improving metabolic and neural stability. Some studies have shown that this diet can normalize schizophrenia-like behaviors in animal models and may offer metabolic and neuroprotective benefits for people with schizophrenia. ^{1 2 3 4 5}

Is the ketogenic diet safe for humans?

The ketogenic diet is generally considered safe for humans and has been shown to improve cardiovascular and metabolic health markers, especially in overweight or obese individuals. However, more controlled clinical trials are needed to confirm these findings in people with serious mental illnesses like schizophrenia. ^{1 2 3 4 6}

How is the ketogenic diet treatment different from other treatments for schizophrenia?

The ketogenic diet is unique because it shifts the body's energy source from glucose to ketones, which are a more efficient fuel for the brain. This diet may improve brain function and stability, potentially providing relief from schizophrenia symptoms while also benefiting metabolic health, unlike traditional treatments that primarily focus on neurotransmitter balance. ^{1 2 3 4 6}

Research Team

Deanna L Kelly, Pharm.D., BCPP

Principal Investigator

Study Principal Investigator

Eligibility Criteria

Adults aged 18-64 with schizophrenia or schizoaffective disorder, stable on antipsychotics for at least two weeks, and a BMI over 18.5 can join this trial. They must score sufficiently on tests to show they understand the consent process. Excluded are pregnant women, those with severe heart, kidney or liver issues, certain metabolic disorders, eating disorders or alcohol use disorder.

Inclusion Criteria

Minimum score of 45 on BPRS

I have been diagnosed with schizophrenia or schizoaffective disorder.

My antipsychotic medication dose has been stable for the last 14 days.

Exclusion Criteria

Refusal to eat intervention diet, food allergies or restrictions that the kitchen cannot accommodate, and/or dietary noncompliance with dietary energy needs

Corrected QT interval (QTc) prolongation greater than or equal to 500ms

I have a serious kidney condition.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants follow a ketogenic diet or a regular diet for 3 months

12 weeks

Weekly visits for assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Ketogenic Diet
• Regular Diet

Trial Overview This study is testing whether a ketogenic diet (high fat, low carb) helps improve symptoms of schizophrenia compared to a regular diet. It's designed as a double-blind controlled trial but hasn't been done before due to challenges in monitoring food intake in patients.

Participant Groups

Group I: Ketogenic Diet Active Control 1 Intervention

Group II: Regular Diet Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials

729

Recruited

540,000+

Findings from Research

A low-carbohydrate, ketogenic diet led to the unexpected resolution of long-term symptoms in a patient with schizophrenia, suggesting a potential dietary intervention for managing this condition.

The improvement may be linked to metabolic changes from eliminating gluten and possible cellular-level modulation of schizophrenia, indicating a novel approach to treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Schizophrenia, gluten, and low-carbohydrate, ketogenic diets: a case report and review of the literature. Kraft, BD., Westman, EC.[2021]

Chronic administration of β-hydroxybutyrate (BHB) in mice replicated the therapeutic effects of a ketogenic diet, normalizing behaviors associated with schizophrenia in a model using NMDA receptor antagonism.

BHB treatment not only reduced hyperactivity and improved social interaction but also addressed disruptions in sensory processing, suggesting it could be a promising alternative treatment for schizophrenia by improving cerebral glucose metabolism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of beta-hydroxybutyrate administration on MK-801-induced schizophrenia-like behaviour in mice. Kraeuter, AK., Mashavave, T., Suvarna, A., et al.[2020]

Recent studies indicate that individuals with schizophrenia may experience dysfunction in glucose and energy metabolism, which could contribute to their symptoms, providing a rationale for the use of a ketogenic diet.

The ketogenic diet has shown promise in preclinical models and case studies, improving psychiatric symptoms and metabolic issues in patients with schizophrenia, suggesting it could be a novel therapeutic approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ketogenic diet for schizophrenia: clinical implication. Sarnyai, Z., Kraeuter, AK., Palmer, CM.[2020]

Individuals with schizophrenia, even those who are medication-naïve, show disrupted insulin and glucose metabolism, increasing their risk for Type 2 diabetes and cardiovascular diseases.

A ketogenic diet may offer significant benefits for people with schizophrenia by improving brain metabolism, cognitive function, and overall metabolic health, suggesting a need for further clinical trials to explore its efficacy and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Ketogenic Metabolic Therapy on the Brain in Serious Mental Illness: A Review. Sethi, S., Ford, JM.[2022]

The ketogenic diet (KD), characterized by high fat and low carbohydrate intake, has shown promise in reducing symptoms of various psychiatric disorders based on a review of 14 studies.

While the results indicate a positive response for individuals adhering to the KD, further research is needed to clarify the specific benefits and mechanisms of action in psychiatric conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of the ketogenic diet in the treatment of psychiatric disorders. Tillery, EE., Ellis, KD., Threatt, TB., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Schizophrenia, gluten, and low-carbohydrate, ketogenic diets: a case report and review of the literature. [2021]

2. Germany pubmed.ncbi.nlm.nih.gov

Effects of beta-hydroxybutyrate administration on MK-801-induced schizophrenia-like behaviour in mice. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Ketogenic diet for schizophrenia: clinical implication. [2020]

4. England pubmed.ncbi.nlm.nih.gov

The Role of Ketogenic Metabolic Therapy on the Brain in Serious Mental Illness: A Review. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Fat consumption and schizophrenia. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

The use of the ketogenic diet in the treatment of psychiatric disorders. [2023]