What side effects are associated with this type of intervention?

Common treatments for schizophrenia include antipsychotic medications, mood stabilizers, and dietary interventions like the ketogenic diet. Antipsychotic medications can cause side effects such as weight gain, diabetes, cardiovascular issues, and movement disorders (e.g., tardive dyskinesia). Mood stabilizers may lead to side effects like dizziness, weight gain, and gastrointestinal issues. The ketogenic diet, which is being studied for its potential benefits in improving cognitive function and neural network stability, may cause side effects such as nutrient deficiencies, gastrointestinal discomfort, and increased cholesterol levels. Overall, while these treatments can be effective, they also come with a range of potential side effects that need to be managed under medical supervision.

What prior FDA approvals exist?

The FDA has approved several antipsychotic medications for the treatment of schizophrenia, including both first-generation (typical) and second-generation (atypical) antipsychotics. Examples include clozapine, risperidone, and aripiprazole. These medications primarily work by modulating neurotransmitter activity, particularly dopamine and serotonin pathways, to manage symptoms. While these treatments do not directly align with the ketogenic diet's mechanism of providing an alternative energy source to glucose, they are the mainstay of current schizophrenia management. Research is ongoing to explore metabolic interventions like the ketogenic diet for their potential benefits in improving cognitive function and neural network stability in schizophrenia.

What other types of research exist?

Promising novel alternatives to the ketogenic diet for schizophrenia patients include omega-3 fatty acid supplementation and transcranial magnetic stimulation (TMS). Both have shown potential in improving cognitive function and neural network stability.

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Other

Ketogenic Diet for Schizophrenia

N/A

Recruiting

Research Sponsored by Northern California Institute of Research and Education

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or female ages 18-65 years old

Diagnosed with SCID-5 Schizophrenia or schizoaffective disorder stable on 2nd generation anti-psychotic (SZ) or bipolar disorder (BD)

Must not have

Diagnosis of other SCID-5 Axis 1 disorder

Current Cancer diagnosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (0 weeks) and posttreatment (4 weeks)

Awards & highlights

Summary

This trial investigates whether a high-fat, low-carbohydrate ketogenic diet can improve brain function in people with schizophrenia and bipolar disorder. The diet aims to use fats instead of sugars for energy, which may help stabilize brain networks and reduce inflammation. The ketogenic diet has shown potential benefits in treating psychiatric conditions by restoring brain energy metabolism.

Who is the study for?

This trial is for adults aged 18-65 with schizophrenia or schizoaffective disorder stable on second-generation antipsychotics, or bipolar disorder. Participants must speak English, have internet access, and be able to heat up ketogenic meals. They should commit to a 4-week ketogenic diet. Exclusions include current cancer diagnosis, other major psychiatric disorders, pregnancy/breastfeeding, type 1 diabetes, history of weight loss surgery or significant weight changes.

What is being tested?

The study tests if a very low carbohydrate ketogenic diet can improve cognitive deficits in individuals with schizophrenia or bipolar disorder by stabilizing neural networks. The diet consists of roughly 70% fat, 20% protein, and 10% carbohydrates and aims to shift the brain's energy source from glucose to ketones.

What are the potential side effects?

Potential side effects of a ketogenic diet may include fatigue during initial adjustment ('keto flu'), digestive issues like constipation or diarrhea due to high-fat intake, possible nutrient deficiencies without proper planning and supplementation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 65 years old.

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I have been diagnosed with schizophrenia, schizoaffective disorder, or bipolar disorder and am stable on medication.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with a mental health disorder.

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I have been diagnosed with cancer.

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I have been diagnosed with type 1 Diabetes Mellitus.

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I am taking medication to lower my blood sugar or for weight loss, but not metformin.

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I have had weight loss surgery in the past.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (0 weeks) and posttreatment (4 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (0 weeks) and posttreatment (4 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (0 weeks) and posttreatment (4 weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in body composition after 4 weeks

Change in insulin resistance after 4 weeks

Change in network stabilization after 4 weeks

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Ketogenic DietExperimental Treatment1 Intervention

The ketogenic diet is a normo-caloric diet composed of high-fat (70%), low-carbohydrate (10%), and adequate protein (20%) that induces fasting-like effects and the production of ketone bodies. Metabolic Meals will be delivered to KETO subjects' homes via courier, consisting of 3 meals a day plus snacks, targeting 70% fat, 20% protein, 10% carbohydrates.

Group II: Diet as usualActive Control1 Intervention

The Diet As Usual (DAU) participants will be asked to maintain their current dietary habits and will be discouraged from starting new diets during the 4-week study.

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for schizophrenia primarily include antipsychotic medications, which work by modulating neurotransmitter systems, particularly dopamine and serotonin receptors, to reduce psychotic symptoms. Clozapine, for example, is effective in treatment-resistant cases and helps manage motor phenomena. Adjunctive treatments like mood stabilizers and omega-3 fatty acids are used to address impulsivity and behavioral dyscontrol. These treatments are crucial as they target the symptomatic relief of schizophrenia, improving patients' quality of life. In comparison, the ketogenic diet offers a novel approach by potentially stabilizing neural networks and enhancing cognitive function through an alternative energy source, ketones, which may address underlying metabolic dysfunctions seen in schizophrenia.

The past and future of novel, non-dopamine-2 receptor therapeutics for schizophrenia: A critical and comprehensive review.[Diagnosis and treatment of motor phenomena in schizophrenia spectrum disorders].Randomized, placebo-controlled clinical trial of omega-3 as supplemental treatment in schizophrenia.

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Who is running the clinical trial?

Northern California Institute of Research and EducationLead Sponsor

28 Previous Clinical Trials

10,014 Total Patients Enrolled

~8 spots leftby Feb 2025

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