<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/NCT01671124</url>
  </required_header>
  <id_info>
    <org_study_id>Fer-01</org_study_id>
    <nct_id>NCT01671124</nct_id>
  </id_info>
  <brief_title>The Study of Antidepressant Properties and Safety of Fer-01(Soline®) on the Patients With Depression</brief_title>
  <official_title>Phase IIa Study of Antidepression Use Natural Plants Extracted of Soline Capsule.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Taipei Medical University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Taipei Medical University Shuang Ho Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Taipei Medical University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Considering the potential modulatory effects of Salvia divinorum, Lycium, Chenpi and Dihuang&#xD;
      supplementation on mood, this study is a clinical study of Soline® (product mixed with Salvia&#xD;
      divinorum, Lycium, Chenpi and Dihuang ) supplementation to investigate the effect of&#xD;
      attenuating the occurrence of depression. The study will enroll 100 patients who meet the&#xD;
      inclusion and exclusion criteria. The trial will be concluded when a total of evaluable 80&#xD;
      patients (40 patients in each treatment group).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Depression is one of the major metal disorders associated with symptoms such as regular&#xD;
      negative moods, decreased physical activities, feeling of helplessness, and cognitive&#xD;
      deficits. According to the seminal &quot;burden of disease&quot; study by World Health Organization&#xD;
      (WHO) has predicted that by 2030 depression will be the second leading cause of disease. The&#xD;
      Diagnostic and Statistical Manual of Mental Disorders (DSM) is the American Psychiatric&#xD;
      Association's standard reference for psychiatry which includes over 400 different definitions&#xD;
      of mental disorders. Selective and reversible monoamine oxidase inhibitor, selective&#xD;
      serotonin reuptake inhibitors or serotonin and noradrenaline reuptake inhibitors are the&#xD;
      typical antidepressants usually. Unfortunately, current drug therapies for depression are not&#xD;
      ideal. Most of the drugs are synthetic nitrogen-bearing compounds which have inevitably some&#xD;
      serious adverse-effects such as causing cardiovascular disease, insomnia and ovarian&#xD;
      teratomas. Hence, there is an urgent need for the research and development of more effective&#xD;
      antidepressants without any/ with minor adverse-effect. Up to the present, many Chinese&#xD;
      medicinal plants have been successfully used to treat sentimental diseases, which is similar&#xD;
      to depression in the Western medicine. Shamans of the Mazatec people of Oaxaca, Mexico have&#xD;
      used Salvia divinorum for at least centuries in ethnomedical practices including spiritual&#xD;
      healing and divinorum. Salvia divinorum contains the known psychoactive constituent&#xD;
      salvinorin A, which is a trans-neoclerodancediterpenoid and a к-opioid agonist with no&#xD;
      activity at the 5-HT2A serotonin receptor, making it an ideal agent for antidepressant.&#xD;
      Salvia divinorum use occurring in Europe and Japan, and survey research suggests that user&#xD;
      claim positive after-effects. Lycium, Chenpi ( Citrus reticulate Blanco ) and Dihuang (&#xD;
      Rehmannia glutinosa ) were widely used in the vast majority of Chinese medicine prescription&#xD;
      to treat mental disease, for example, Lily Bulb Decoction to Preserve the Lung ( Lycium and&#xD;
      Dihuang ) from Analytic Collection of Medical Formula , Spirit-quieting Decoction ( Chenpi )&#xD;
      form Restoring Health from Tens of Thousands of Diseases. Considering the potential&#xD;
      modulatory effects of Salvia divinorum, Lycium, Chenpi and Dihuang supplementation on mood,&#xD;
      this study is a clinical study of Soline® (product mixed with Salvia divinorum, Lycium,&#xD;
      Chenpi and Dihuang ) supplementation to investigate the effect of attenuating the occurrence&#xD;
      of depression.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2012</start_date>
  <completion_date type="Anticipated">November 2013</completion_date>
  <primary_completion_date type="Anticipated">July 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>DSM-IV</measure>
    <time_frame>Day 1 and up to 6 weeks</time_frame>
    <description>diagnosis of major depressive disorder according to DSM-Ⅳ has change</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>analysis of inflammation cytokine</measure>
    <time_frame>Day 1 and up to 6 weeks</time_frame>
    <description>Laboratory examination parameters ( TNF-a,IL-6, TGF-b1)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>analysis of basic biochemical</measure>
    <time_frame>Day 1 and up to 6 weeks</time_frame>
    <description>The incidence of hepatic and renal adverse events(GOT, GTP, BUN, creatinine...)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fatty acid composition</measure>
    <time_frame>Day 1 and up to 6 weeks</time_frame>
    <description>Fatty acid composition is measure with gas chromatography.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">1</enrollment>
  <condition>Major Depressive Disorder</condition>
  <arm_group>
    <arm_group_label>Soline capsule</arm_group_label>
    <description>Salvia divinorum, Lycium, Chenpi and Dihuang</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Soline capsule</intervention_name>
    <arm_group_label>Soline capsule</arm_group_label>
    <other_name>prozac</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        community sample, residents of Taiwan&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        •Clinical diagnosis of major depressive disorder&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy and nursing&#xD;
&#xD;
          -  Schizophrenia spectrum disorder&#xD;
&#xD;
          -  Manic depressive disorder&#xD;
&#xD;
          -  Bipolar disorder&#xD;
&#xD;
          -  Anxiety Disorder&#xD;
&#xD;
          -  Abnormal biochemistry analysis value:( AST and ALT≧triple the upper limit of normal)；&#xD;
&#xD;
          -  Serum creatinine&gt;2mg/dl&#xD;
&#xD;
          -  BUN&gt;40mg/dL&#xD;
&#xD;
          -  Total bilirubin&gt;2.0mg/dL&#xD;
&#xD;
          -  Hematocrit&lt;30&#xD;
&#xD;
          -  White blood count≧15000&#xD;
&#xD;
          -  High sensitivity to this product&#xD;
&#xD;
          -  The diseases will influence of results: pulmonary tuberculosis, uncontrolled diabetes,&#xD;
             uncontrolled hypertension, serious infection and critical cardiovascular, liver,&#xD;
             kidney disease.&#xD;
&#xD;
          -  Alcohol abuse or drug abuse&#xD;
&#xD;
          -  Attended the other study in last 4 weeks&#xD;
&#xD;
          -  Attempted suicide or self-injurious&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shih-Yi Huang, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Taipei Medical University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Taipei Mecical University Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>100</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yu-Ru Guo, master</last_name>
      <phone>886227361661</phone>
      <phone_ext>6549</phone_ext>
      <email>dinyty@hotmail.com</email>
    </contact>
    <investigator>
      <last_name>Chih-Chiang Chiu, Ph.D</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Hsin-Chien Lee, Ph.D</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Shih-Yi Huang, Ph.D</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 15, 2012</study_first_submitted>
  <study_first_submitted_qc>August 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 23, 2012</study_first_posted>
  <last_update_submitted>September 9, 2012</last_update_submitted>
  <last_update_submitted_qc>September 9, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 11, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>TG</keyword>
  <keyword>TC</keyword>
  <keyword>HDL</keyword>
  <keyword>LDL</keyword>
  <keyword>Albumin</keyword>
  <keyword>Hemoglobin</keyword>
  <keyword>Hematocrit</keyword>
  <keyword>Uric acid</keyword>
  <keyword>Sodium</keyword>
  <keyword>Potassium</keyword>
  <keyword>Calcium</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depressive Disorder</mesh_term>
    <mesh_term>Depressive Disorder, Major</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/NCT01671124
org study id: Fer-01
nct id: NCT01671124
lead sponsor: 
collaborator: 
has dmc: Yes
Considering the potential modulatory effects of Salvia divinorum, Lycium, Chenpi and Dihuang
      supplementation on mood, this study is a clinical study of Soline® (product mixed with Salvia
      divinorum, Lycium, Chenpi and Dihuang ) supplementation to investigate the effect of
      attenuating the occurrence of depression. The study will enroll 100 patients who meet the
      inclusion and exclusion criteria. The trial will be concluded when a total of evaluable 80
      patients (40 patients in each treatment group).
Depression is one of the major metal disorders associated with symptoms such as regular
      negative moods, decreased physical activities, feeling of helplessness, and cognitive
      deficits. According to the seminal "burden of disease" study by World Health Organization
      (WHO) has predicted that by 2030 depression will be the second leading cause of disease. The
      Diagnostic and Statistical Manual of Mental Disorders (DSM) is the American Psychiatric
      Association's standard reference for psychiatry which includes over 400 different definitions
      of mental disorders. Selective and reversible monoamine oxidase inhibitor, selective
      serotonin reuptake inhibitors or serotonin and noradrenaline reuptake inhibitors are the
      typical antidepressants usually. Unfortunately, current drug therapies for depression are not
      ideal. Most of the drugs are synthetic nitrogen-bearing compounds which have inevitably some
      serious adverse-effects such as causing cardiovascular disease, insomnia and ovarian
      teratomas. Hence, there is an urgent need for the research and development of more effective
      antidepressants without any/ with minor adverse-effect. Up to the present, many Chinese
      medicinal plants have been successfully used to treat sentimental diseases, which is similar
      to depression in the Western medicine. Shamans of the Mazatec people of Oaxaca, Mexico have
      used Salvia divinorum for at least centuries in ethnomedical practices including spiritual
      healing and divinorum. Salvia divinorum contains the known psychoactive constituent
      salvinorin A, which is a trans-neoclerodancediterpenoid and a к-opioid agonist with no
      activity at the 5-HT2A serotonin receptor, making it an ideal agent for antidepressant.
      Salvia divinorum use occurring in Europe and Japan, and survey research suggests that user
      claim positive after-effects. Lycium, Chenpi ( Citrus reticulate Blanco ) and Dihuang (
      Rehmannia glutinosa ) were widely used in the vast majority of Chinese medicine prescription
      to treat mental disease, for example, Lily Bulb Decoction to Preserve the Lung ( Lycium and
      Dihuang ) from Analytic Collection of Medical Formula , Spirit-quieting Decoction ( Chenpi )
      form Restoring Health from Tens of Thousands of Diseases. Considering the potential
      modulatory effects of Salvia divinorum, Lycium, Chenpi and Dihuang supplementation on mood,
      this study is a clinical study of Soline® (product mixed with Salvia divinorum, Lycium,
      Chenpi and Dihuang ) supplementation to investigate the effect of attenuating the occurrence
      of depression.
observational model: Cohort
time perspective: Prospective
measure: DSM-IV
time frame: Day 1 and up to 6 weeks
description: diagnosis of major depressive disorder according to DSM-Ⅳ has change
measure: analysis of inflammation cytokine
time frame: Day 1 and up to 6 weeks
description: Laboratory examination parameters ( TNF-a,IL-6, TGF-b1)
measure: analysis of basic biochemical
time frame: Day 1 and up to 6 weeks
description: The incidence of hepatic and renal adverse events(GOT, GTP, BUN, creatinine...)
measure: Fatty acid composition
time frame: Day 1 and up to 6 weeks
description: Fatty acid composition is measure with gas chromatography.
arm group label: Soline capsule
description: Salvia divinorum, Lycium, Chenpi and Dihuang
intervention type: Other
intervention name: Soline capsule
arm group label: Soline capsule
other name: prozac
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 60 Years
healthy volunteers: No
last name: Shih-Yi Huang, Ph.D
role: Principal Investigator
affiliation: Taipei Medical University
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
country: Taiwan
responsible party type: Sponsor
mesh term: Depressive Disorder
mesh term: Depressive Disorder, Major