<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/NCT03251716</url>
  </required_header>
  <id_info>
    <org_study_id>Ber-open-2015-TJAH</org_study_id>
    <nct_id>NCT03251716</nct_id>
  </id_info>
  <brief_title>Berberine Treat Metabolic Syndrome in Schizophrenia</brief_title>
  <official_title>Berberine in the Treatment of Metabolic Syndrome : an Open Label Clinical Study in Female Schizophrenia Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tianjin Anding Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tianjin Anding Hospital</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>
      In early clinical study investigators confirmed that berberine could prevent glucose and&#xD;
      lipid metabolism disorder in schizophrenia, so investigators intend to verify the effect and&#xD;
      safety of berberine in treatment for metabolic syndrome in schizophrenia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is an open lable clinical intervention trial, include 30 female subjects with&#xD;
      diagnosis of schizophrenia and metabolic syndrome.Participants will be given berberine（&#xD;
      300mgTID） as an add-on therapy lasting 8 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2015</start_date>
  <completion_date type="Actual">December 30, 2017</completion_date>
  <primary_completion_date type="Actual">October 30, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change of FBG</measure>
    <time_frame>Change from Baseline serum fasting biood glucose at 8 weeks</time_frame>
    <description>Serum fasting biood glucose</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of TG</measure>
    <time_frame>Change from Baseline serum triglyceride at 8 weeks</time_frame>
    <description>Serum triglyceride</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of LDL</measure>
    <time_frame>Change from Baseline serum low density lipoprotein at 8 weeks</time_frame>
    <description>Serum low density lipoprotein</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of BP</measure>
    <time_frame>Change from Baseline Systolic Blood Pressure at 8 weeks</time_frame>
    <description>Systolic blood pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of waist</measure>
    <time_frame>Change from Baseline waistline at 8 weeks</time_frame>
    <description>Waistline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of BP</measure>
    <time_frame>Change from Baseline Diastolic Blood Pressure at 8 weeks</time_frame>
    <description>Diastolic blood pressure</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Metabolic Syndrome</condition>
  <condition>Female</condition>
  <condition>Schizophrenia</condition>
  <arm_group>
    <arm_group_label>berberine adjunctive group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Only one treatment group in this study, without a preset control group,subjects who meet the criteria will entere the berberine adjunctive group</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>berberine</intervention_name>
    <description>berberine 300mg TID add-on for berberine adjunctive group</description>
    <arm_group_label>berberine adjunctive group</arm_group_label>
    <other_name>berberine hydrochloride</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. subjects with the diagnosis of schizophrenia depend on Statistical Manual, Fifth&#xD;
             Edition (DSM-5) ;&#xD;
&#xD;
          2. Female subjects aged 18-60 years;&#xD;
&#xD;
          3. monotherapy of atypical antipsychotics for 2 weeks or more , including olanzapine,&#xD;
             clozapine, risperidone, and perphenazine；&#xD;
&#xD;
          4. subjects with diagnosis of metabolic syndrome depending on guidelines for the&#xD;
             prevention and treatment of dyslipidemia in Chinese adults in 2007;&#xD;
&#xD;
          5. the subjects and their guardians sign the informed consent agreement.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. subjects with diagnosis of other psychiatric disorders except schizophrenia depend on&#xD;
             DSM-5;&#xD;
&#xD;
          2. chronic organic diseases involving any central nervous system, such as tumors and&#xD;
             inflammation, brain trauma, active seizures, vascular diseases, Parkinson's disease,&#xD;
             myasthenia gravis, and other degenerative diseases;&#xD;
&#xD;
          3. a history of gastrointestinal surgery or the presence of any possibility of&#xD;
             interfering with the absorption, distribution, metabolism, or excretion of drugs&#xD;
             situation;&#xD;
&#xD;
          4. used long-acting antipsychotic drugs or receive electroconvulsive therapy (MECT) or&#xD;
             receive transcranial magnetic stimulation therapy in the last 1 months;&#xD;
&#xD;
          5. serious physical diseases, including uncontrolled hypertension, severe cardiovascular,&#xD;
             cerebrovascular, and pulmonary diseases, thyroid diseases, etc;&#xD;
&#xD;
          6. currently receiving anti-inflammatory or immunosuppressive treatment, including oral&#xD;
             steroids;&#xD;
&#xD;
          7. a history of chronic infection, including tuberculosis, AIDS and hepatitis;&#xD;
&#xD;
          8. allergic to berberine,or hemolytic anemia or glucose -6- phosphate dehydrogenase&#xD;
             deficiency;&#xD;
&#xD;
          9. pregnant women, lactating women；&#xD;
&#xD;
         10. participants were involved in other clinical trials within 1 months prior to the&#xD;
             signing of informed consent&#xD;
&#xD;
         11. other reasons judged by the researchers to be inappropriate for the clinical study.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Tianjin Anding Hospital</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <zip>300222</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>August 3, 2017</study_first_submitted>
  <study_first_submitted_qc>August 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 16, 2017</study_first_posted>
  <last_update_submitted>April 24, 2018</last_update_submitted>
  <last_update_submitted_qc>April 24, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 25, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Metabolic syndrome</keyword>
  <keyword>Schizophrenia</keyword>
  <keyword>Efficacy</keyword>
  <keyword>Female</keyword>
  <keyword>Berberine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metabolic Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
    <mesh_term>Schizophrenia</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03251716
org study id: Ber-open-2015-TJAH
nct id: NCT03251716
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
In early clinical study investigators confirmed that berberine could prevent glucose and
      lipid metabolism disorder in schizophrenia, so investigators intend to verify the effect and
      safety of berberine in treatment for metabolic syndrome in schizophrenia.
This study is an open lable clinical intervention trial, include 30 female subjects with
      diagnosis of schizophrenia and metabolic syndrome.Participants will be given berberine（
      300mgTID） as an add-on therapy lasting 8 weeks.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change of FBG
time frame: Change from Baseline serum fasting biood glucose at 8 weeks
description: Serum fasting biood glucose
measure: Change of TG
time frame: Change from Baseline serum triglyceride at 8 weeks
description: Serum triglyceride
measure: Change of LDL
time frame: Change from Baseline serum low density lipoprotein at 8 weeks
description: Serum low density lipoprotein
measure: Change of BP
time frame: Change from Baseline Systolic Blood Pressure at 8 weeks
description: Systolic blood pressure
measure: Change of waist
time frame: Change from Baseline waistline at 8 weeks
description: Waistline
measure: Change of BP
time frame: Change from Baseline Diastolic Blood Pressure at 8 weeks
description: Diastolic blood pressure
arm group label: berberine adjunctive group
arm group type: Experimental
description: Only one treatment group in this study, without a preset control group,subjects who meet the criteria will entere the berberine adjunctive group
intervention type: Drug
intervention name: berberine
description: berberine 300mg TID add-on for berberine adjunctive group
arm group label: berberine adjunctive group
other name: berberine hydrochloride
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
facility: 
country: China
responsible party type: Sponsor
mesh term: Metabolic Syndrome
mesh term: Syndrome
mesh term: Schizophrenia