What side effects are associated with this type of intervention?

Common treatments for schizophrenia include antipsychotic medications, which often have side effects such as weight gain, diabetes, dyslipidemia, sedation, and extrapyramidal symptoms (e.g., tremors, rigidity). The ketogenic diet, which is being studied as an alternative treatment, may offer benefits in reducing psychiatric symptoms and improving metabolic outcomes. However, potential side effects of the ketogenic diet can include gastrointestinal issues, nutrient deficiencies, and difficulty adhering to the diet long-term.

What prior FDA approvals exist?

The FDA has approved several antipsychotic medications for the treatment of schizophrenia, including both first-generation (e.g., haloperidol, chlorpromazine) and second-generation antipsychotics (e.g., clozapine, aripiprazole, olanzapine). While these medications primarily target dopamine receptors to alleviate symptoms, none specifically induce ketosis or provide ketone bodies as an alternative energy source to cells. The ketogenic diet, which has shown promise in improving schizophrenia symptoms in some studies, represents a novel approach by altering metabolic pathways rather than directly targeting neurotransmitter systems.

What other types of research exist?

Promising novel alternatives to the ketogenic diet for schizophrenia patients include: 1) Omega-3 fatty acids, which have shown potential in reducing symptoms in clinical trials. 2) Folinic acid and methylcobalamin, which may improve adaptive behavior and verbal communication. 3) Sulforaphane, which has demonstrated efficacy in randomized controlled trials. 4) Mind-body therapies such as yoga and Qigong massage, which have shown benefits in improving overall functioning and sensory regulation. These alternatives should be discussed with a healthcare provider to tailor the best treatment plan for individual needs.

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Ketogenic Diet for Schizophrenia

N/A

Recruiting

Led By Deanna L Kelly, Pharm.D., BCPP

Research Sponsored by University of Maryland, Baltimore

Eligibility Criteria Checklist

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

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

Study Summary

This trial finds that a ketogenic diet may be as effective as antipsychotic drugs in treating schizophrenia, with potential additional benefits on metabolic outcomes.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects from the ketogenic diet may include digestive discomforts like constipation or diarrhea initially, possible nutrient deficiencies if not monitored properly and changes in blood lipid levels.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Assessment of positive and negative symptoms

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Ketogenic DietActive Control1 Intervention

Group II: Regular DietPlacebo Group1 Intervention

Do I qualify?Apply below to find out

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 involve antipsychotic medications, which work by blocking dopamine receptors (typical antipsychotics) or modulating both dopamine and serotonin receptors (atypical antipsychotics). This helps reduce the positive symptoms of schizophrenia, such as hallucinations and delusions. The ketogenic diet, which induces ketosis and provides ketone bodies as an alternative energy source, is being studied for its potential to improve schizophrenia symptoms. This diet may influence brain metabolism and neurotransmitter systems, offering a novel approach that could complement traditional antipsychotic treatments. Understanding these mechanisms is crucial for optimizing treatment strategies and improving patient outcomes.

Optimizing the glutamatergic challenge model for psychosis, using S+ -ketamine to induce psychomimetic symptoms in healthy volunteers.Differential effects of clozapine and haloperidol on ketamine-induced brain metabolic activation.

Find a Location

Who is running the clinical trial?

University of Maryland, BaltimoreLead Sponsor

692 Previous Clinical Trials

376,814 Total Patients Enrolled

66 Trials studying Schizophrenia

10,207 Patients Enrolled for Schizophrenia

Deanna L Kelly, Pharm.D., BCPPPrincipal InvestigatorStudy Principal Investigator

3 Previous Clinical Trials

586 Total Patients Enrolled

3 Trials studying Schizophrenia

586 Patients Enrolled for Schizophrenia

Media Library

Ketogenic Diet (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05968638 — N/A

Schizophrenia Research Study Groups: Regular Diet, Ketogenic Diet

Schizophrenia Clinical Trial 2023: Ketogenic Diet Highlights & Side Effects. Trial Name: NCT05968638 — N/A

Ketogenic Diet (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05968638 — N/A

~33 spots leftby Aug 2026

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