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Ketogenic Diet in People With Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT05968638
Recruitment Status : Recruiting
First Posted : August 1, 2023
Last Update Posted : September 25, 2023
Information provided by (Responsible Party):
Deanna Kelly, University of Maryland, Baltimore

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 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

Condition or disease Intervention/treatment Phase
Schizophrenia Schizo Affective Disorder Other: Regular Diet Other: Ketogenic Diet Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be assigned to receive either a ketogenic diet or regular diet
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: single-blind
Primary Purpose: Treatment
Official Title: Single-Blind Randomized Ketogenic Diet vs. Control Diet in People With Schizophrenia
Actual Study Start Date : September 1, 2023
Estimated Primary Completion Date : August 1, 2026
Estimated Study Completion Date : August 1, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Placebo Comparator: Regular Diet Other: Regular Diet
Regular Diet

Active Comparator: Ketogenic Diet Other: Ketogenic Diet
Ketogenic Diet

Primary Outcome Measures :
  1. Assessment of positive and negative symptoms [ Time Frame: 3 months ]
    Brief Psychiatric Rating Scale (BPRS): The BPRS scale will be the primary outcome measure. It will be administered at baseline and at the end of each week. The BPRS is considered the most widely used symptom rating scale in psychiatric research, is highly sensitive to change, and has excellent interrater reliability with appropriate training of raters. The BPRS assesses the level of 18 symptom constructs such as hostility, suspiciousness, hallucination, and grandiosity. The rater enters a number for each symptom construct that ranges from 1 (not present) to 7 (extremely severe). The score ranges from 18-126, with the higher the number the worse the symptoms.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Age 18- 64 years
  2. Diagnostic and Statistical Manual (DSM-IV/DSM 5) diagnosis of schizophrenia or schizoaffective 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 Sign Consent.

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 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
  7. 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
  8. Porphyria
  9. Genetic disorders that affect fat metabolism (Gaucher disease, Tay-Sachs disease, medium-chain acyl-CoA dehydrogenase deficiency (MCADD)
  10. Carnitine deficiency syndromes (primary carnitine deficiency, carnitine palmitoyltransferase deficiency, carnitine translocase deficiency)
  11. Pyruvate kinase deficiency
  12. Gastroparesis
  13. Refusal to eat intervention diet, food allergies or restrictions that the kitchen cannot accommodate, and/or dietary noncompliance with dietary energy needs

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT05968638

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Contact: AnnMarie Kearns, MS 410-402-6854
Contact: Matthew Glassman, MS 410-402-6411

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United States, Maryland
Maryland Psychiatric Research Center (MPRC) Treatment Research Program (TRP) Recruiting
Catonsville, Maryland, United States, 21228
Contact: AnnMarie Kearns, MS    410-402-6854   
Sponsors and Collaborators
University of Maryland, Baltimore
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Principal Investigator: Deanna L Kelly, Pharm.D., BCPP Study Principal Investigator
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Responsible Party: Deanna Kelly, Chief and Director, Treatment Research Program, University of Maryland, Baltimore Identifier: NCT05968638    
Other Study ID Numbers: HP-00106193
First Posted: August 1, 2023    Key Record Dates
Last Update Posted: September 25, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Mood Disorders
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders