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Ketogenic Diet in People With Schizophrenia

Primary Purpose

Schizophrenia, Schizo Affective Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Regular Diet
Ketogenic Diet
Sponsored by
University of Maryland, Baltimore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 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: 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Regular Diet

Ketogenic Diet

Arm Description

Outcomes

Primary Outcome Measures

Assessment of positive and negative symptoms
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.

Secondary Outcome Measures

Full Information

First Posted
July 12, 2023
Last Updated
September 21, 2023
Sponsor
University of Maryland, Baltimore
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1. Study Identification

Unique Protocol Identification Number
NCT05968638
Brief Title
Ketogenic Diet in People With Schizophrenia
Official Title
Single-Blind Randomized Ketogenic Diet vs. Control Diet in People With Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2023 (Actual)
Primary Completion Date
August 1, 2026 (Anticipated)
Study Completion Date
August 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizo Affective Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be assigned to receive either a ketogenic diet or regular diet
Masking
InvestigatorOutcomes Assessor
Masking Description
single-blind
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Regular Diet
Arm Type
Placebo Comparator
Arm Title
Ketogenic Diet
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Regular Diet
Intervention Description
Regular Diet
Intervention Type
Other
Intervention Name(s)
Ketogenic Diet
Intervention Description
Ketogenic Diet
Primary Outcome Measure Information:
Title
Assessment of positive and negative symptoms
Description
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.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
AnnMarie Kearns, MS
Phone
410-402-6854
Email
akearns@som.umaryland.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Matthew Glassman, MS
Phone
410-402-6411
Email
mglassman@som.umaryland.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deanna L Kelly, Pharm.D., BCPP
Organizational Affiliation
Study Principal Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maryland Psychiatric Research Center (MPRC) Treatment Research Program (TRP)
City
Catonsville
State/Province
Maryland
ZIP/Postal Code
21228
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
AnnMarie Kearns, MS
Phone
410-402-6854
Email
akearns@som.umaryland.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Ketogenic Diet in People With Schizophrenia

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