Ketogenic Diet in People With Schizophrenia

Last updated: October 2, 2024
Sponsor: University of Maryland, Baltimore
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Affective Disorders

Tourette's Syndrome

Schizophrenia And Schizoaffective Disorders (Pediatric)

Treatment

Ketogenic Diet

Regular Diet

Clinical Study ID

NCT05968638
HP-00106193
  • Ages 18-64
  • All Genders

Study 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 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age 18- 64 years

  2. Diagnostic and Statistical Manual (DSM-IV/DSM 5) diagnosis of schizophrenia orschizoaffective disorder

  3. Antipsychotic regimen with no dose change in last 14 days

  4. Minimum score of 45 on BPRS

  5. Body mass index > 18.5

  6. Ability to consent determined by a score of 10 or greater on the Evaluation to SignConsent.

Exclusion

Exclusion Criteria:

  1. Pregnant or lactating females

  2. Type I diabetes or insulin dependent Type II diabetes

  3. Current diagnosis of DSM 5 eating disorder

  4. Heart failure

  5. corrected QT interval (QTc) prolongation greater than or equal to 500ms

  6. 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 clinicianwill 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

  1. Significant liver disease. Indicators for possible acute or chronic liver disease. Each is not usedindividually 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/orComplete 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, chronichepatitis, autoimmune hepatitis, primary biliary cirrhosis (PBC), primarySclerosing Cholangitis (PSC) alpha-1 antitrypsin deficiency, hereditaryhemochromatosis, Budd-Chiari syndrome)

  • History of liver transplantation

  1. Porphyria

  2. Genetic disorders that affect fat metabolism (Gaucher disease, Tay-Sachs disease,medium-chain acyl-CoA dehydrogenase deficiency (MCADD)

  3. Carnitine deficiency syndromes (primary carnitine deficiency, carnitinepalmitoyltransferase deficiency, carnitine translocase deficiency)

  4. Pyruvate kinase deficiency

  5. Gastroparesis

  6. Refusal to eat intervention diet, food allergies or restrictions that the kitchencannot accommodate, and/or dietary noncompliance with dietary energy needs

Study Design

Total Participants: 50
Treatment Group(s): 2
Primary Treatment: Ketogenic Diet
Phase:
Study Start date:
September 01, 2023
Estimated Completion Date:
August 01, 2027

Connect with a study center

  • Maryland Psychiatric Research Center (MPRC) Treatment Research Program (TRP)

    Catonsville, Maryland 21228
    United States

    Site Not Available

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