CLINICAL TRIAL

Ketogenic diet for Schizophrenia

Recruiting · 18+ · All Sexes · San Francisco, CA

Can Neural Network Instability in Schizophrenia be Improved With a Very Low Carbohydrate Ketogenic Diet?

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About the trial for Schizophrenia

Treatment Groups

This trial involves 2 different treatments. Ketogenic Diet is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Ketogenic diet
OTHER
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
You are a male or female aged 40 to 65 years old. show original
SCID-5 Schizophrenia or schizoaffective disorder stable on 2nd generation anti-psychotic
You are between 27 and 43 kilograms per square metre. show original
You are willing to follow a 4-week ketogenic diet. show original
Speak, read, comprehend English
Access to internet
Willing and able to heat up KETO meals
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Baseline (0 weeks) and posttreatment (4 weeks)
Screening: ~3 weeks
Treatment: Varies
Reporting: Baseline (0 weeks) and posttreatment (4 weeks)
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Baseline (0 weeks) and posttreatment (4 weeks).
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Ketogenic diet will improve 5 primary outcomes in patients with Schizophrenia. Measurement will happen over the course of Baseline (0 weeks).

Cognition Battery
BASELINE (0 WEEKS)
Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS). This will enable the direct assessment of the relationship between network stability at baseline and cognition using the MATRICS battery to determine if the known relationship with general cognition in neuro-typical adults is also seen in SZ.
BASELINE (0 WEEKS)
Change in insulin resistance after 4 weeks
BASELINE (0 WEEKS) AND POSTTREATMENT (4 WEEKS)
Insulin resistance will be indirectly determined from fasting glucose and insulin levels using the homeostasis model assessment of insulin resistance (HOMA-IR). Plasma glucose and insulin levels will be determined by the VA Clinical Lab.
BASELINE (0 WEEKS) AND POSTTREATMENT (4 WEEKS)
Change in systemic inflammation after 4 weeks
BASELINE (0 WEEKS) AND POSTTREATMENT (4 WEEKS)
Systemic inflammation will be assayed by plasma C-Reactive Protein levels (VA Clinical Lab).
BASELINE (0 WEEKS) AND POSTTREATMENT (4 WEEKS)
Change in body composition after 4 weeks
BASELINE (0 WEEKS) AND POSTTREATMENT (4 WEEKS)
Body composition will be determined by calculating the waist-hip ratio.
BASELINE (0 WEEKS) AND POSTTREATMENT (4 WEEKS)
Change in network stabilization after 4 weeks
BASELINE (0 WEEKS) AND POSTTREATMENT (4 WEEKS)
Will measure dynamic connectivity by assessing how long a network of independent nodes, within and between brain regions, maintains a stable connection. Instability or dynamic connectivity quantifies stochastic processes or other potential heterogeneity in connectivity over time at baseline and at 4 weeks (post-treatment).
BASELINE (0 WEEKS) AND POSTTREATMENT (4 WEEKS)

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes schizophrenia?

Schizophrenia can be caused by many different factors related to the environment, genetics, and the neurotransmitter glutamate. Some of these factors, such as birth order and the mother's mental illnesses, can affect childhood development. But there is some evidence that schizophrenia has an inherited component with a genetic variant in the gene "DISC1" being one cause of the disease.

Anonymous Patient Answer

Can schizophrenia be cured?

There is strong resistance to antipsychotic therapy for schizophrenia in most populations, with an estimated prevalence rate of one percent per year at diagnosis of schizophrenia. The only viable treatments for schizophrenia are medical ones, focused on improving the symptomatology of schizophrenia. Given the wide range of symptom severity and response to treatment, one person may not respond to all psychiatric care.

Anonymous Patient Answer

What is schizophrenia?

Schizophrenia causes psychosis, hallucinations, and emotional problems. Symptoms can range from minimal to mild to severe cases that can lead to long-term disability. Schizophrenia is more common in women and develops in adolescence; onset is often earlier in males (before age 30). Schizophrenia, as defined by categorical criteria, is diagnosed in some 75,000 Americans per year. Schizophrenia is named after J. Schizophrenicus, the Greek-Mediterranean doctor who first described the illness in the fifth century BCE. He was the first doctor to use the term as the basis of his diagnosis.

Anonymous Patient Answer

How many people get schizophrenia a year in the United States?

The American Psychiatric Association (APA) estimates 260,823 Americans will be diagnosed with schizophrenia in 2022. Together, these 2 estimates of the number of people diagnosed with schizophrenia in 2022 amount to an annual rate of almost 20,000 new cases.

Anonymous Patient Answer

What are the signs of schizophrenia?

A long history of psychosis, and the presence of delusions and hallucinations during the first episode of psychosis, are two significant independent risk factors for developing schizophrenia.

Anonymous Patient Answer

What are common treatments for schizophrenia?

In a recent study, findings of this study show that both of the medications that are frequently abused by schizophrenic individuals in the United States are effective for milder forms of schizophrenia, and that they are the only commonly used medication that is effective for moderate to severe types of schizophrenia.

Anonymous Patient Answer

Is ketogenic diet safe for people?

Data from a recent study of this study demonstrate that following a KD, the vast majority of people have an adverse event. Although most of these events are mild, severe ones are possible. Physicians and dietitians recommend careful monitoring in the first 2 years of a patient’s KD before deciding whether an individual’s condition will improve or deteriorate because of the diet. In particular, an elevated baseline triglyceride level (a surrogate marker for high carbohydrate intake) is consistently seen in people on a ketogenic diet. Elevated baseline triglycerides may be a reflection of a genetic predisposition for dyslipidaemia.

Anonymous Patient Answer

Does schizophrenia run in families?

Although schizophrenia is largely thought of as a typical onset condition, a significant proportion of the cases appear to be atypical, with familial and environmental risk factors playing a role in the development of the psychotic episodes. Results from a recent clinical trial highlight the need to continue to identify the genetic influences on this severe disabling disease, but suggest that these could be amenable to pharmacological intervention

Anonymous Patient Answer

Has ketogenic diet proven to be more effective than a placebo?

Results from a recent paper has confirmed the effectiveness of the ketogenic diet compared to a placebo as well as its superiority over antiepileptic drugs and anticonvulsants in a broad spectrum of medical indications, being especially good for intractable status epilepticus. This has major implications for the future use of KD in epilepsy management.

Anonymous Patient Answer

How serious can schizophrenia be?

Patients with schizophrenia are highly distressed by their illness, and there appears to be a tendency toward more severe symptoms as the illness progresses over time. The impact of mental illness on a person's quality of life is also considerable, and the impact on families is perhaps even greater. We suggest greater attention to the family in psychiatry as a way to improve the situation of people with schizophrenia.

Anonymous Patient Answer

Have there been other clinical trials involving ketogenic diet?

This is the first report of randomized, placebo-controlled, double-blinded study assessing the efficacy of an individualized KD treatment in patients with schizophrenia. The findings of the present study suggest that a specific and individualized KD should be thoroughly investigated as a potential therapeutic modality in patients with schizophrenia.

Anonymous Patient Answer

What is the latest research for schizophrenia?

Although advances in technology and neuroscience can advance the medical care in treating schizophrenic patients, the management of schizophrenia has not changed much. This is unfortunate because patients and their caregivers are still waiting for their first definitive therapy option being effective. Currently, first-line therapy for improving quality of life for all patients with schizophrenia is the use of antipsychotic drugs, which are first line of treatment. There may be several problems with the current paradigm, including the efficacy and safety of both neuroleptic drugs and antidepressants. Neuroleptic discontinuation syndrome (NES) is a condition that some patients develop when treated with neuroleptic drugs. It is characterized by physical and mental symptoms of psychosis and can cause psychiatric admission.

Anonymous Patient Answer
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