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Ketogenic Diet for Schizophrenia

N/A
Waitlist Available
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

Summary

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.

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.
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.
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 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

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

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
713 Previous Clinical Trials
379,299 Total Patients Enrolled
67 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
~27 spots leftby Aug 2026