NCT05968638

Ketogenic Diet in People With Schizophrenia

Active, enrolled NA Last updated 12 November 2025

What this trial tests

NA trial testing Regular Diet in Schizophrenia in 50 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

1 September 2023

Primary endpoint
1 August 2026

1 August 2027

Quick facts

Lead sponsor	University of Maryland, Baltimore
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	50
Start date	1 September 2023
Primary completion	1 August 2026
Estimated completion	1 August 2027
Sites	1 location across United States

Drugs / interventions tested

• Regular Diet
• Ketogenic Diet — full drug profile →

Conditions studied

• Schizophrenia — all drugs for Schizophrenia →
• Schizo Affective Disorder — all drugs for Schizo Affective Disorder →

Sponsor

University of Maryland, Baltimore

Who can join

Adults 18 to 64, any sex, with Schizophrenia or Schizo Affective Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. The Potential Role of the Ketogenic Diet in Serious Mental Illness: Current Evidence, Safety, and Practical Advice.
   Rog J, Wingralek Z, Nowak K, Grudzień M, et al · · 2024 · cited 12× · PMID 38792361 · DOI 10.3390/jcm13102819
2. Ketogenic therapy for schizophrenia: evidence, mechanisms, and clinical perspectives.
   Chaves C, Fabe J, Gomes FA, McNeely H, et al · · 2025 · cited 2× · PMID 40635756 · DOI 10.3389/fphar.2025.1603722