xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05968638</url>
    </required_header>
    <id_info>
      <org_study_id>HP-00106193</org_study_id>
      <nct_id>NCT05968638</nct_id>
    </id_info>
    <brief_title>Single-Blind Randomized Ketogenic Diet vs. Control Diet in People With Schizophrenia</brief_title>
    <official_title>Single-Blind Randomized Ketogenic Diet vs. Control Diet in People With Schizophrenia</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Maryland, Baltimore</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Maryland, Baltimore</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Schizophrenia is a serious mental disorder with a heterogenous presentation, lack of clear&#xD;
        understanding of pathophysiology and only partially effective treatments. First-line&#xD;
        antipsychotic drugs block dopamine, but many people continue to suffer from persistent&#xD;
        positive or negative symptoms that cannot be fully treated with available medications.&#xD;
        Recently, our group has found that dietary modulations have efficacy comparable to&#xD;
        antipsychotic medications and that determining which patients could benefit from a&#xD;
        personalized treatment framework is critical.&#xD;
  &#xD;
        The ketogenic diet consists of low-carbohydrate, moderate protein and high fat intake&#xD;
        inducing a state in which ketone bodies in the blood provide energy to the cells. In&#xD;
        pharmacologic mouse models a ketogenic diet regimen resulted in complete restoration of&#xD;
        normal behaviors, independent of strict caloric restriction and other work has suggested that&#xD;
        a ketogenic diet may improve schizophrenia like deficits in rodents. An open label ketogenic&#xD;
        diet study in the 1950s reported improvement in schizophrenia symptom. At least 7 additional&#xD;
        case reports have found robust improvements or complete resolution of schizophrenia symptoms.&#xD;
        Recently a retrospective study found robust and significant improvements in schizophrenia&#xD;
        symptoms in 10 schizoaffective disorder patients treated with a ketogenic diet. In addition&#xD;
        to psychiatric symptoms, improvements in metabolic outcomes have been demonstrated. However,&#xD;
        to date, there have been no published double blind randomized controlled trials evaluating&#xD;
        the effects of a ketogenic diet since few sites can conduct inpatient trials and have&#xD;
        observation and control for food intake&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 1, 2023</start_date>
    <completion_date type="Anticipated">August 1, 2027</completion_date>
    <primary_completion_date type="Anticipated">August 1, 2026</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Participants will be assigned to receive either a ketogenic diet or regular diet</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Investigator, Outcomes Assessor)</masking>
      <masking_description>single-blind</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Assessment of positive and negative symptoms</measure>
      <time_frame>3 months</time_frame>
      <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.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Schizophrenia</condition>
    <condition>Schizo Affective Disorder</condition>
    <arm_group>
      <arm_group_label>Regular Diet</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Ketogenic Diet</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Regular Diet</intervention_name>
      <description>Regular Diet</description>
      <arm_group_label>Regular Diet</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Ketogenic Diet</intervention_name>
      <description>Ketogenic Diet</description>
      <arm_group_label>Ketogenic Diet</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age 18- 64 years&#xD;
  &#xD;
            2. DSM-IV/DSM 5 diagnosis of schizophrenia or schizoaffective disorder&#xD;
  &#xD;
            3. Antipsychotic regimen with no dose change in last 14 days&#xD;
  &#xD;
            4. Minimum score of 45 on BPRS&#xD;
  &#xD;
            5. Body mass index &gt; 18.5&#xD;
  &#xD;
            6. Ability to consent determined by a score of 10 or greater on the Evaluation to Sign&#xD;
               Consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Pregnant or lactating females&#xD;
  &#xD;
            2. Type I diabetes or insulin dependent Type II diabetes&#xD;
  &#xD;
            3. Current diagnosis of DSM 5 eating disorder&#xD;
  &#xD;
            4. Heart failure&#xD;
  &#xD;
            5. QTc prolongation greater than or equal to 500ms&#xD;
  &#xD;
            6. Significant kidney disease [11, 12]&#xD;
  &#xD;
               Indicators for possible acute kidney injury (AKI) or moderate chronic kidney disease&#xD;
               (CKD) based on some factors below. Each is not used individually but a clinician will&#xD;
               determine based on the following:&#xD;
  &#xD;
                 -  Creatinine &gt; 1.3mg/dL&#xD;
  &#xD;
                 -  GFR &lt; 60 mL/min/1.73 m2&#xD;
  &#xD;
                 -  Renal tubular disorders&#xD;
  &#xD;
                 -  History of kidney transplantation&#xD;
  &#xD;
            7. Significant liver disease.[13, 14]&#xD;
  &#xD;
               Indicators for possible acute or chronic liver disease. Each is not used individually&#xD;
               but a clinician will determine based on the following:&#xD;
  &#xD;
                 -  Prolonged INR greater than or equal to 1.5, elevated bilirubin and&#xD;
                    aminotransferases (3x normal upper limit) and/or CBC abnormalities&#xD;
                    (thrombocytopenia, anemia)&#xD;
  &#xD;
                 -  Physical examination abnormalities (jaundice, icteric sclera, asterixis)&#xD;
  &#xD;
                 -  Alcohol use disorder (AUD) based on DSM 5 criteria for moderate AUD&#xD;
  &#xD;
                 -  History of liver disease (cirrhosis, Wilson disease, Gilbert disease, chronic&#xD;
                    hepatitis, autoimmune hepatitis, primary biliary cirrhosis (PBC), primary&#xD;
                    Sclerosing Cholangitis (PSC) alpha-1 antitrypsin deficiency, hereditary&#xD;
                    hemochromatosis, Budd-Chiari syndrome)&#xD;
  &#xD;
                 -  History of liver transplantation&#xD;
  &#xD;
            8. Porphyria&#xD;
  &#xD;
            9. Genetic disorders that affect fat metabolism (Gaucher disease, Tay-Sachs disease,&#xD;
               MCADD (medium-chain acyl-CoA dehydrogenase deficiency)&#xD;
  &#xD;
           10. Carnitine deficiency syndromes (primary carnitine deficiency, carnitine&#xD;
               palmitoyltransferase deficiency, carnitine translocase deficiency)&#xD;
  &#xD;
           11. Pyruvate kinase deficiency [15]&#xD;
  &#xD;
           12. Gastroparesis&#xD;
  &#xD;
           13. Refusal to eat intervention diet, food allergies or restrictions that the kitchen&#xD;
               cannot accommodate, and/or dietary noncompliance with dietary energy needs&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>64 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Deanna L Kelly, Pharm.D., BCPP</last_name>
      <role>Principal Investigator</role>
      <affiliation>Study Principal Investigator</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>AnnMarie Kearns, MS</last_name>
      <phone>410-402-6854</phone>
      <email>akearns@som.umaryland.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Matthew Glassman, MS</last_name>
      <phone>410-402-6411</phone>
      <email>mglassman@som.umaryland.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Maryland Psychiatric Research Center (MPRC) Treatment Research Program (TRP)</name>
        <address>
          <city>Catonsville</city>
          <state>Maryland</state>
          <zip>21228</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 12, 2023</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 26, 2023</last_update_submitted>
    <last_update_submitted_qc>July 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Maryland, Baltimore</investigator_affiliation>
      <investigator_full_name>Deanna Kelly</investigator_full_name>
      <investigator_title>Chief and Director, Treatment Research Program</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Schizophrenia</mesh_term>
      <mesh_term>Mood Disorders</mesh_term>
      <mesh_term>Psychotic Disorders</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05968638
  org study id: HP-00106193
  nct id: NCT05968638
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  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
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Participants will be assigned to receive either a ketogenic diet or regular diet
  primary purpose: Treatment
  masking: Double (Investigator, Outcomes Assessor)
  masking description: single-blind
  measure: Assessment of positive and negative symptoms
  time frame: 3 months
  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.
  arm group label: Regular Diet
  arm group type: Placebo Comparator
  arm group label: Ketogenic Diet
  arm group type: Active Comparator
  intervention type: Other
  intervention name: Regular Diet
  description: Regular Diet
  arm group label: Regular Diet
  intervention type: Other
  intervention name: Ketogenic Diet
  description: Ketogenic Diet
  arm group label: Ketogenic Diet
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 64 Years
  healthy volunteers: No
  last name: Deanna L Kelly, Pharm.D., BCPP
  role: Principal Investigator
  affiliation: Study Principal Investigator
  last name: AnnMarie Kearns, MS
  phone: 410-402-6854
  email: akearns@som.umaryland.edu
  last name: Matthew Glassman, MS
  phone: 410-402-6411
  email: mglassman@som.umaryland.edu
  facility: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: University of Maryland, Baltimore
  investigator full name: Deanna Kelly
  investigator title: Chief and Director, Treatment Research Program
  mesh term: Schizophrenia
  mesh term: Mood Disorders
  mesh term: Psychotic Disorders
  sharing ipd: No