Ketogenic Diet in People With Schizophrenia (NCT05968638)
Single-Blind Randomized Ketogenic Diet vs. Control Diet in People With Schizophrenia
🩺 Plain-English Summary (8th-Grade Level)
Schizophrenia is a serious mental disorder with a heterogenous presentation, lack of clear understanding of pathophysiology and only partially effective treatments. First-line antipsychotic drugs block dopamine, but many people continue to suffer from persistent positive or negative symptoms that cannot be fully treated with available medications. Recently, our group has found that dietary modulations have efficacy comparable to antipsychotic medications and that determining which patients could benefit from a personalized treatment framework is critical. The ketogenic diet consists of low-carbohydrate, moderate protein and high fat intake inducing a state in which ketone bodies in the blood provide energy to the cells. In pharmacologic mouse models a ketogenic diet regimen resulted in complete restoration of normal behaviors, independent of strict caloric restriction and other work has suggested that a ketogenic diet may improve schizophrenia like deficits in rodents. An open label ketogenic diet study in the 1950s reported improvement in schizophrenia symptom. At least 7 additional case reports have found robust improvements or complete resolution of schizophrenia symptoms. Recently a retrospective study found robust and significant improvements in schizophrenia symptoms in 10 schizoaffective disorder patients treated with a ketogenic diet. In addition to psychiatric symptoms, improvements in metabolic outcomes have been demonstrated. However, to date, there have been no published double blind randomized controlled trials evaluating the effects of a ketogenic diet since few sites can conduct inpatient trials and have observation and control for food intake
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (6 items) and avoid the listed exclusions (23 items).
Location: Maryland Psychiatric Research Center (MPRC) Treatment Research Program (TRP) — Catonsville, Maryland
Age range: 18 Years to 64 Years
🧪 Interventions in This Study
- Regular Diet (OTHER)
- Ketogenic Diet (OTHER)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Pregnant or lactating females
- Type I diabetes or insulin dependent Type II diabetes
- Current diagnosis of DSM 5 eating disorder
- Heart failure
- corrected QT interval (QTc) prolongation greater than or equal to 500ms
- Significant kidney disease Indicators for possible acute kidney injury (AKI) or moderate chronic kidney disease (CKD) based on some factors below. Each is not used individually but a clinician will determine based on the following:
- Creatinine \> 1.3mg/dL
- Glomerular Filtration Rate (GFR) \< 60 mL/min/1.73 m2
- Renal tubular disorders
- History of kidney transplantation
- Significant liver disease. Indicators for possible acute or chronic liver disease. Each is not used individually but a clinician will determine based on the following:
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- Maryland Psychiatric Research Center (MPRC) Treatment Research Program (TRP) — Catonsville, Maryland
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Schizophrenia
- Young Adults With Violent Behavior During Early Psychosis (Aim 2) — New York, New York
- Does tDCS Change Synaptic Density in the Brains of Patients With Schizophrenia — Toronto, Ontario
- Enhancing Prefrontal Oscillations and Working Memory in Early-course Schizophrenia — Pittsburgh, Pennsylvania
- Genetic Basis of the Risk and Consequences of Cannabis Exposure in Humans — West Haven, Connecticut
- REACH Study (Recovery Environments: Assessing Cognitive & Brain Health in Community Mental Health) — Cleveland, Ohio
Explore by condition: All Schizophrenia clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.