Status:
ACTIVE_NOT_RECRUITING
Ketogenic Diet in People With Schizophrenia
Lead Sponsor:
University of Maryland, Baltimore
Conditions:
Schizophrenia
Schizo Affective Disorder
Eligibility:
All Genders
18-64 years
Phase:
NA
Brief Summary
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 bloc...
Eligibility Criteria
Inclusion
- Age 18- 64 years
- Diagnostic and Statistical Manual (DSM-IV/DSM 5) diagnosis of schizophrenia or schizoaffective disorder
- Antipsychotic regimen with no dose change in last 14 days
- Minimum score of 45 on BPRS
- Body mass index \> 18.5
- Ability to consent determined by a score of 10 or greater on the Evaluation to Sign Consent.
Exclusion
- 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:
- Prolonged International Normalized Ratio (INR) greater than or equal to 1.5, elevated bilirubin and aminotransferases (3x normal upper limit) and/or Complete Blood Count (CBC) abnormalities (thrombocytopenia, anemia)
- Physical examination abnormalities (jaundice, icteric sclera, asterixis)
- Alcohol use disorder (AUD) based on DSM 5 criteria for moderate AUD
- History of liver disease (cirrhosis, Wilson disease, Gilbert disease, chronic hepatitis, autoimmune hepatitis, primary biliary cirrhosis (PBC), primary Sclerosing Cholangitis (PSC) alpha-1 antitrypsin deficiency, hereditary hemochromatosis, Budd-Chiari syndrome)
- History of liver transplantation
- Porphyria
- Genetic disorders that affect fat metabolism (Gaucher disease, Tay-Sachs disease, medium-chain acyl-CoA dehydrogenase deficiency (MCADD)
- Carnitine deficiency syndromes (primary carnitine deficiency, carnitine palmitoyltransferase deficiency, carnitine translocase deficiency)
- Pyruvate kinase deficiency
- Gastroparesis
- Refusal to eat intervention diet, food allergies or restrictions that the kitchen cannot accommodate, and/or dietary noncompliance with dietary energy needs
Key Trial Info
Start Date :
September 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2027
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05968638
Start Date
September 1 2023
End Date
August 1 2027
Last Update
November 12 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Maryland Psychiatric Research Center (MPRC) Treatment Research Program (TRP)
Catonsville, Maryland, United States, 21228