<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/NCT01699490</url>
  </required_header>
  <id_info>
    <org_study_id>NSC 101-2314-B-006 -064 -MY3</org_study_id>
    <nct_id>NCT01699490</nct_id>
  </id_info>
  <brief_title>Role of Inflammation Factors and Insulin Resistance in Major Depressive Disorder</brief_title>
  <official_title>Role of Inflammation Factors and Insulin Resistance in the Pathophysiology and Treatment Response of Major Depressive Disorder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Cheng-Kung University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Science Council, Taiwan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>National Cheng-Kung University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to identify evidence-based guidelines for treating major&#xD;
      depressive disorder to full remission in Taiwanese major depressive disorder (MDD) patients.&#xD;
      To achieve this goal, the investigators aim to: (1) evaluate the risks and benefits of&#xD;
      adjunctive pharmacotherapies for cognitive and metabolic consequences in MDD, and (2) clarify&#xD;
      the shared biological mechanisms between mood, immune and metabolism homeostasis&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The prevalence of insulin resistance did not significantly differ among the healthy controls&#xD;
      and drug-naïve MDD patients before and after antidepressant treatment. Meanwhile, the current&#xD;
      study indicated that antidepressants might affect insulin secretion independently of the&#xD;
      therapeutic effects on MDD. Therapeutic strategies considering both treatment effectiveness&#xD;
      and glucose-insulin homeostasis in MDD patients are necessary.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2012</start_date>
  <completion_date type="Anticipated">July 2015</completion_date>
  <primary_completion_date type="Anticipated">July 2015</primary_completion_date>
  <phase>Phase 4</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hamilton Depression Rating Scale (HDRS)</measure>
    <time_frame>12 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>fasting plasma glucose</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>fasting serum insulin</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>C-reactive Protein, and IL-6</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Major Depressive Disorder</condition>
  <arm_group>
    <arm_group_label>Fluoxetine + Valsartan</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The initial dose of fluoxetine was 20 mg once daily, which could be increased by 20 mg in divided doses to a maximal daily dose of 60 mg.&#xD;
Add-on treatment to 40 mg per day of valsartan</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fluoxetine + Placebo</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The initial dose of fluoxetine was 20 mg once daily, which could be increased by 20 mg in divided doses to a maximal daily dose of 60 mg.&#xD;
Add-on treatment to placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fluoxetine + Valsartan</intervention_name>
    <description>The curative effect of fluoxetine add-on valsartan 40 mg per day for 12 weeks therapy in the treatment of major depressive disorder.</description>
    <arm_group_label>Fluoxetine + Valsartan</arm_group_label>
    <other_name>Prozac</other_name>
    <other_name>Diovan</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fluoxetine + Placebo</intervention_name>
    <description>The curative effect of fluoxetine add-on placebo therapy in the treatment of major depressive disorder.</description>
    <arm_group_label>Fluoxetine + Placebo</arm_group_label>
    <other_name>Prozac</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age: 16-65 years old&#xD;
&#xD;
          -  Signed informed consent by patient or legal representative&#xD;
&#xD;
          -  Hamilton Rating Scale for Depression (HDRS) scores ≥ 16&#xD;
&#xD;
          -  A diagnosis of MDD according to DSM-IV criteria made by a specialist in psychiatry&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Monoamine oxidase inhibitor or antidepressant treatment prior to entering the study&#xD;
&#xD;
          -  A DSM-IV diagnosis of substance abuse within the past three months&#xD;
&#xD;
          -  An organic mental disease, mental retardation or dementia&#xD;
&#xD;
          -  A serious surgical condition or physical illness&#xD;
&#xD;
          -  Patients who were pregnant or breastfeeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Po See Chen, M.D., Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Cheng-Kung University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Po See Chen, M.D., Ph.D.</last_name>
    <phone>+886-6-2353535</phone>
    <phone_ext>5213</phone_ext>
    <email>chenps@mail.ncku.edu.tw</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of Psychiatry, National Cheng-Kung University Hospital</name>
      <address>
        <city>Tainan</city>
        <zip>701</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Po See Chen, M.D., Ph.D.</last_name>
      <phone>+886-6-2353535</phone>
      <phone_ext>5213</phone_ext>
      <email>chenps@mail.ncku.edu.tw</email>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 30, 2012</study_first_submitted>
  <study_first_submitted_qc>October 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2012</study_first_posted>
  <last_update_submitted>September 26, 2014</last_update_submitted>
  <last_update_submitted_qc>September 26, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 29, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Cheng-Kung University Hospital</investigator_affiliation>
    <investigator_full_name>Po-See, Chen</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Major Depressive Disorder</keyword>
  <keyword>Antidepressants</keyword>
  <keyword>Insulin</keyword>
  <keyword>Fluoxetine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Insulin Resistance</mesh_term>
    <mesh_term>Inflammation</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder, Major</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Valsartan</mesh_term>
    <mesh_term>Fluoxetine</mesh_term>
  </intervention_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/NCT01699490
org study id: NSC 101-2314-B-006 -064 -MY3
nct id: NCT01699490
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to identify evidence-based guidelines for treating major
      depressive disorder to full remission in Taiwanese major depressive disorder (MDD) patients.
      To achieve this goal, the investigators aim to: (1) evaluate the risks and benefits of
      adjunctive pharmacotherapies for cognitive and metabolic consequences in MDD, and (2) clarify
      the shared biological mechanisms between mood, immune and metabolism homeostasis
The prevalence of insulin resistance did not significantly differ among the healthy controls
      and drug-naïve MDD patients before and after antidepressant treatment. Meanwhile, the current
      study indicated that antidepressants might affect insulin secretion independently of the
      therapeutic effects on MDD. Therapeutic strategies considering both treatment effectiveness
      and glucose-insulin homeostasis in MDD patients are necessary.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Hamilton Depression Rating Scale (HDRS)
time frame: 12 weeks
measure: fasting plasma glucose
time frame: 12 weeks
measure: fasting serum insulin
time frame: 12 weeks
measure: C-reactive Protein, and IL-6
time frame: 12 weeks
arm group label: Fluoxetine + Valsartan
arm group type: Experimental
description: The initial dose of fluoxetine was 20 mg once daily, which could be increased by 20 mg in divided doses to a maximal daily dose of 60 mg.
Add-on treatment to 40 mg per day of valsartan
arm group label: Fluoxetine + Placebo
arm group type: Active Comparator
description: The initial dose of fluoxetine was 20 mg once daily, which could be increased by 20 mg in divided doses to a maximal daily dose of 60 mg.
Add-on treatment to placebo
intervention type: Drug
intervention name: Fluoxetine + Valsartan
description: The curative effect of fluoxetine add-on valsartan 40 mg per day for 12 weeks therapy in the treatment of major depressive disorder.
arm group label: Fluoxetine + Valsartan
other name: Prozac
other name: Diovan
intervention type: Drug
intervention name: Fluoxetine + Placebo
description: The curative effect of fluoxetine add-on placebo therapy in the treatment of major depressive disorder.
arm group label: Fluoxetine + Placebo
other name: Prozac
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Po See Chen, M.D., Ph.D
role: Principal Investigator
affiliation: National Cheng-Kung University Hospital
last name: Po See Chen, M.D., Ph.D.
phone: +886-6-2353535
phone ext: 5213
email: chenps@mail.ncku.edu.tw
facility: 
status: Recruiting
contact: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: National Cheng-Kung University Hospital
investigator full name: Po-See, Chen
investigator title: Associate Professor
mesh term: Insulin Resistance
mesh term: Inflammation
mesh term: Depressive Disorder
mesh term: Depression
mesh term: Depressive Disorder, Major
mesh term: Valsartan
mesh term: Fluoxetine