Ketogenic Diet for Mental Illness

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Mclean Hospital

Disqualifiers: No longer meeting original criteria

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

50 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a 12-week open-label extension study for participants completing study NCT06221852.

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

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the ketogenic diet as a treatment for mental illness?

Research shows that the ketogenic diet, which is high in fat and low in carbohydrates, has been effective in treating epilepsy and other neurological conditions. This suggests it may also help with mental illnesses by altering brain metabolism. ^{1 2 3 4 5}

Is the ketogenic diet generally safe for humans?

The ketogenic diet has been used safely in various conditions, including epilepsy and metabolic disorders, with medical supervision. It is important to have a healthcare team involved to monitor and manage any potential side effects. ^{1 5 6 7 8}

How does the ketogenic diet treatment differ from other treatments for mental illness?

The ketogenic diet is unique because it is a high-fat, low-carbohydrate diet that has been traditionally used to treat epilepsy and is now being explored for mental illnesses. Unlike standard drug treatments, it works by altering the body's metabolism, which may help improve brain function and reduce symptoms in psychiatric disorders. ^{1 2 4 7 9}

Research Team

Virginie-Anne Chouinard, MD

Principal Investigator

Mclean Hospital

Eligibility Criteria

This trial is for individuals who have completed the initial 12-week study NCT06221852 and still meet the original criteria. It's aimed at those with conditions like schizoaffective disorder, psychosis, mental illness, or bipolar disorder.

Inclusion Criteria

I completed the 12-week NCT06221852 study and met all its entry requirements.

Exclusion Criteria

No longer meeting original entry criteria from the randomized 12-week study of NCT06221852.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Open-label Extension

Participants follow the ketogenic diet for 12 weeks with diet counseling and daily monitoring of blood ketone and glucose levels

12 weeks

Regular visits for diet counseling and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Treatment Details

Interventions

• Ketogenic diet

Trial Overview Participants will continue to follow a ketogenic diet over an additional 12 weeks. This extension of the previous study allows researchers to gather more data on its long-term effects in managing psychiatric disorders.

Participant Groups

Group I: Ketogenic diet Experimental Treatment 1 Intervention

Participants will be asked to follow the ketogenic diet (KD) for 12 weeks in addition to any ongoing medications (e.g., mood stabilizers and/or second-generation antipsychotics). Participants will receive diet counseling from a registered dietitian. Participants will be asked to monitor and report their blood ketone and glucose levels each day via a finger-prick device provided by the study team.

Who Is Running the Clinical Trial?

Mclean Hospital

Lead Sponsor

Trials

221

Recruited

22,500+

Baszucki Family Foundation

Collaborator

Trials

2

Recruited

100+

Findings from Research

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]

In a mouse model of malignant glioma, a ketogenic diet (KetoCal®) significantly increased survival by approximately 5 days compared to a standard diet, indicating its potential as a supportive treatment in cancer therapy.

The combination of the ketogenic diet and radiation therapy showed more than additive effects, with tumor growth significantly reduced in most mice on the ketogenic diet, suggesting that metabolic changes from the diet could enhance the effectiveness of conventional cancer treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The ketogenic diet is an effective adjuvant to radiation therapy for the treatment of malignant glioma. Abdelwahab, MG., Fenton, KE., Preul, MC., et al.[2022]

In a study of 31 adults with severe mental illnesses, a ketogenic diet significantly improved depression and psychosis symptoms, as shown by reductions in Hamilton Depression Rating Scale scores from 25.4 to 7.7 and PANSS scores from 91.4 to 49.3, all with P < 0.001.

The ketogenic diet was well-tolerated and also led to improvements in metabolic health markers, including weight, blood pressure, blood glucose, and triglycerides, indicating potential benefits beyond mental health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Ketogenic Diet for Refractory Mental Illness: A Retrospective Analysis of 31 Inpatients. Danan, A., Westman, EC., Saslow, LR., et al.[2022]

In a retrospective analysis of 14 patients on the ketogenic diet (KD) for epilepsy, 3 patients became seizure-free and 7 experienced a reduction of at least 50% in their seizures, demonstrating the diet's potential efficacy in managing resistant epilepsy.

Despite positive outcomes, some patients discontinued the KD due to issues like frequent infections, family concerns, and financial difficulties, highlighting the need for ongoing support and consideration of individual circumstances in treatment plans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ketogenic diet experience at Ondokuz Mayıs University. Tekin, E., Serdaroğlu, FM., Şahin, Ş., et al.[2021]

In a study involving 89 participants with type 2 diabetes, a very low-calorie ketogenic (VLCK) diet led to significantly greater weight loss and improved glycemic control compared to a standard low-calorie diet over 4 months.

The VLCK diet was found to be safe and well-tolerated, with no serious adverse events reported and no significant changes in laboratory safety parameters, indicating it can be a viable option for managing obesity in T2DM patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-term safety, tolerability and efficacy of a very low-calorie-ketogenic diet interventional weight loss program versus hypocaloric diet in patients with type 2 diabetes mellitus. Goday, A., Bellido, D., Sajoux, I., et al.[2022]

A 4-year-old girl with a rare FBXL4 gene mutation and severe lactic acidosis was successfully treated with a ketogenic diet (KD) after standard treatments failed, highlighting the KD's potential in managing mitochondrial disorders.

This case represents the first documented use of parenteral KD to effectively reduce lactic acidosis in a patient with mitochondrial depletion syndrome, suggesting a promising nonpharmacological intervention for similar conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The first case with FBXL4 mutation successfully treated with a parenteral ketogenic diet for lactic acidosis. İnci, A., Aktaş, E., Cengiz Ergin, FB., et al.[2022]

In a study of 199 patients with refractory epilepsy, the ketogenic diet (KD) demonstrated significant efficacy, with 58% of patients experiencing a reduction in seizure frequency of over 50% after 6 months, and 33% becoming seizure-free.

While the KD is generally safe and effective, with most complications being mild, there were five reported deaths, highlighting the need for careful monitoring of patients, especially those with symptomatic and partial epilepsies who may have a higher risk of relapse after discontinuation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of the ketogenic diet for intractable childhood epilepsy: Korean multicentric experience. Kang, HC., Kim, YJ., Kim, DW., et al.[2022]

The ketogenic diet (KD) has shown potential benefits in animal models for various mental disorders, including significant reductions in anxiety and depression-like behaviors, but results in human studies are mixed and not conclusive.

Currently, there is insufficient evidence to recommend KD as a treatment for mental disorders due to limitations in existing studies, such as reliance on animal models and lack of standardized measures like ketone levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Current Status of the Ketogenic Diet in Psychiatry. Bostock, EC., Kirkby, KC., Taylor, BV.[2020]

References

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

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

2. England pubmed.ncbi.nlm.nih.gov

Ketogenic diet as a metabolic treatment for mental illness. [2023]

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

The ketogenic diet is an effective adjuvant to radiation therapy for the treatment of malignant glioma. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

The Ketogenic Diet for Refractory Mental Illness: A Retrospective Analysis of 31 Inpatients. [2022]

5. Italy pubmed.ncbi.nlm.nih.gov

Ketogenic diet experience at Ondokuz Mayıs University. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Short-term safety, tolerability and efficacy of a very low-calorie-ketogenic diet interventional weight loss program versus hypocaloric diet in patients with type 2 diabetes mellitus. [2022]

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

The first case with FBXL4 mutation successfully treated with a parenteral ketogenic diet for lactic acidosis. [2022]

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

Efficacy and safety of the ketogenic diet for intractable childhood epilepsy: Korean multicentric experience. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

The Current Status of the Ketogenic Diet in Psychiatry. [2020]