<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/NCT02191124</url>
  </required_header>
  <id_info>
    <org_study_id>2009-1051</org_study_id>
    <nct_id>NCT02191124</nct_id>
  </id_info>
  <brief_title>The Measurement-based Care in Patients With Depressive Disorder: A Randomized Controlled Trial</brief_title>
  <official_title>Measurement-based Care vs. Standard Care for Major Depressive Disorder: a Randomized Controlled Trial With Masked Raters</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Capital Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Capital Medical University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In recent years, measurement-based care (MBC) has been gaining more attention in the&#xD;
      treatment of depression because it allows psychiatrists to individualize treatment decisions&#xD;
      for each patient based on the change of psychopathology and tolerance toward antidepressants.&#xD;
      Several studies, such as the Sequenced Treatment Alternatives to Relieve Depression (STAR*D)&#xD;
      trial using MBC, found that MBC-informed sequential algorithms can be successfully integrated&#xD;
      into clinical practice and improve patients' outcomes However, despite a strong theoretical&#xD;
      rationale for MBC and data supporting the ability to implement MBC in clinical practice&#xD;
      settings, there is currently no randomized controlled trial in MDD patients comparing MBC&#xD;
      with usual/standard care. The investigators compare MBC with clinician's treatment decisions,&#xD;
      standardizing care to two commonly prescribed antidepressants.&#xD;
&#xD;
      Therefore, the aim of this study is to determine the effects of MBC in patients with MDD&#xD;
      compared to standard treatment (ST). The research hypothesis is that compared to ST, the&#xD;
      estimated time to response and to remission would be significantly shorter in the MBC group&#xD;
      without increased dropout rates and side effect burden.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objective: To compare the effectiveness and feasibility of the measurement-based care (MBC)&#xD;
      in the treatment of depression with clinician's treatment decisions, standardizing treatment&#xD;
      (ST, clinicians' choice decisions) to two commonly prescribed antidepressants.&#xD;
&#xD;
      Methods: Selecting the patients in psychiatric hospitals and general hospitals with&#xD;
      depression, with multi-center randomized controlled study design. Refer to STAR-D&#xD;
      &quot;measurement-based care&quot; mode, to establish the whole measurement-based evaluation system.&#xD;
      Eligible patients will be randomly assigned to 24 weeks of MBC or ST, restricting treatment&#xD;
      to paroxetine (20-60mg/day) or mirtazapine (15-45mg/day) in both groups. the ST group will&#xD;
      maximize simulate of the actual clinical situation, and the patients of the MBC group are&#xD;
      required to complete the prospective Life-chart Methodology (LCM-p), 16-item Quick Inventory&#xD;
      of Depressive Symptomatology Self-Report (QIDS-SR16) and other related symptoms and side&#xD;
      effects of self-assessment, the doctor will make a comprehensive assessment according to the&#xD;
      results of self-assessment, adjust treatment according to research programs. This is 1-year&#xD;
      follow-up study; the independent members will have a blinded assessment in the baseline visit&#xD;
      and each point of view. Depressive symptoms are measured using the Hamilton Rating Scale for&#xD;
      Depression (HAMD) and QIDS-SR.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2011</start_date>
  <completion_date type="Actual">May 2013</completion_date>
  <primary_completion_date type="Actual">November 2012</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>Factorial Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The estimated time from randomization to response and remission according to Hamilton Rating Scale for Depression (HAMD) total score.</measure>
    <time_frame>From randomization to response and remission (24 week))</time_frame>
    <description>Response was defined as ≥50% decrease in the baseline HAMD total score; remission was defined as the HAMD total score ≤7</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The changes of Hamilton Rating Scale for Depression (HAMD) total score</measure>
    <time_frame>From randomization to endpoint (Week 24)</time_frame>
    <description>To measure the change of the severity of depressive symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The incidence and nature of overall adverse events</measure>
    <time_frame>From enrollment to endpoint (Week 24)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The incidence and nature of drug-related adverse events</measure>
    <time_frame>From enrollment to endpoint (Week 24)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The number of subject withdrawal due to adverse events during double-blind phase</measure>
    <time_frame>From randomization to endpoint(Week 24)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The changes of Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR) total score</measure>
    <time_frame>From randomization to endpoint (Week 24)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The changes of Frequency, Intensity, and Burden of Side Effects-Rating (FIBSER)</measure>
    <time_frame>From randomization to endpoint (Week 24)</time_frame>
    <description>The FIBSER is a self-report instrument assessing three domains of medication side effects within the past week</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">164</enrollment>
  <condition>Major Depressive Disorder</condition>
  <arm_group>
    <arm_group_label>measurement-based care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MBC allows psychiatrists to individualize treatment decisions for each patient based on the change of psychopathology and tolerance toward antidepressants. Treatment decisions were made by treating psychiatrists according to ratings of self-report scales obtained at each treatment visit. Paroxetine was started at 20mg/day and then raised to 30mg/day by week 4, 40mg/day by week 6, 50mg/day by week 8 and 60mg/day by week 10. Mirtazapine was started at 15mg/day and raised to 30mg/day by week 1 and 45mg/day by week 4. Dose adjustments were dependent on how long a patient had received a particular dose, symptom changes and side effects.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients in the ST group are treated by their psychiatrists according to their clinical needs as judged at each outpatient visit, receiving either open-label paroxetine (20-60mg/day) or mirtazapine (15-45mg/day) within the therapeutic dose range.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paroxetine</intervention_name>
    <description>Patients in both groups (MBC or ST) receive open-label paroxetine (20-60mg/day) within the therapeutic dose range recommended by the Guidelines for the Prevention and Treatment of Major Depression in China.</description>
    <arm_group_label>Standard treatment</arm_group_label>
    <arm_group_label>measurement-based care</arm_group_label>
    <other_name>Seroxat</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Mirtazapine</intervention_name>
    <description>Patients in both groups (MBC or ST) receive open-label mirtazapine (15-45mg/day) within the therapeutic dose range recommended by the Guidelines for the Prevention and Treatment of Major Depression in China</description>
    <arm_group_label>Standard treatment</arm_group_label>
    <arm_group_label>measurement-based care</arm_group_label>
    <other_name>Remeron</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. age 18-65 years;&#xD;
&#xD;
          2. outpatients;&#xD;
&#xD;
          3. diagnosis of non-psychotic MDD established by treating psychiatrists and confirmed by&#xD;
             a checklist based on DSM-IV criteria at study entry ;&#xD;
&#xD;
          4. total score of HAMD-17≥17;&#xD;
&#xD;
          5. ability to communicate and provide written consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. current or past history of drug and alcohol dependence, bipolar, psychotic,&#xD;
             obsessive-compulsive, or eating disorders;&#xD;
&#xD;
          2. history of lack of response or intolerance to any of the two protocol antidepressants&#xD;
             (paroxetine or mirtazapine);&#xD;
&#xD;
          3. being pregnant or breast-feeding;&#xD;
&#xD;
          4. suicide attempts in the current depressive episode or major medical conditions&#xD;
             contraindicating the use of the protocol antidepressants.&#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>Gang Wang, MD;PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beijing Anding Hospital, Capital Medical University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Beijing Anding Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100088</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 10, 2014</study_first_submitted>
  <study_first_submitted_qc>July 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 16, 2014</study_first_posted>
  <last_update_submitted>July 15, 2014</last_update_submitted>
  <last_update_submitted_qc>July 15, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 16, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Capital Medical University</investigator_affiliation>
    <investigator_full_name>Gang Wang</investigator_full_name>
    <investigator_title>vice-director of Affective Disorder Center, Beijing Anding Hospital</investigator_title>
  </responsible_party>
  <keyword>Measurement-based care</keyword>
  <keyword>Unipolar depression</keyword>
  <keyword>Outpatients</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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>Mirtazapine</mesh_term>
    <mesh_term>Paroxetine</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/NCT02191124
org study id: 2009-1051
nct id: NCT02191124
lead sponsor: 
has dmc: Yes
In recent years, measurement-based care (MBC) has been gaining more attention in the
      treatment of depression because it allows psychiatrists to individualize treatment decisions
      for each patient based on the change of psychopathology and tolerance toward antidepressants.
      Several studies, such as the Sequenced Treatment Alternatives to Relieve Depression (STAR*D)
      trial using MBC, found that MBC-informed sequential algorithms can be successfully integrated
      into clinical practice and improve patients' outcomes However, despite a strong theoretical
      rationale for MBC and data supporting the ability to implement MBC in clinical practice
      settings, there is currently no randomized controlled trial in MDD patients comparing MBC
      with usual/standard care. The investigators compare MBC with clinician's treatment decisions,
      standardizing care to two commonly prescribed antidepressants.

      Therefore, the aim of this study is to determine the effects of MBC in patients with MDD
      compared to standard treatment (ST). The research hypothesis is that compared to ST, the
      estimated time to response and to remission would be significantly shorter in the MBC group
      without increased dropout rates and side effect burden.
Objective: To compare the effectiveness and feasibility of the measurement-based care (MBC)
      in the treatment of depression with clinician's treatment decisions, standardizing treatment
      (ST, clinicians' choice decisions) to two commonly prescribed antidepressants.

      Methods: Selecting the patients in psychiatric hospitals and general hospitals with
      depression, with multi-center randomized controlled study design. Refer to STAR-D
      "measurement-based care" mode, to establish the whole measurement-based evaluation system.
      Eligible patients will be randomly assigned to 24 weeks of MBC or ST, restricting treatment
      to paroxetine (20-60mg/day) or mirtazapine (15-45mg/day) in both groups. the ST group will
      maximize simulate of the actual clinical situation, and the patients of the MBC group are
      required to complete the prospective Life-chart Methodology (LCM-p), 16-item Quick Inventory
      of Depressive Symptomatology Self-Report (QIDS-SR16) and other related symptoms and side
      effects of self-assessment, the doctor will make a comprehensive assessment according to the
      results of self-assessment, adjust treatment according to research programs. This is 1-year
      follow-up study; the independent members will have a blinded assessment in the baseline visit
      and each point of view. Depressive symptoms are measured using the Hamilton Rating Scale for
      Depression (HAMD) and QIDS-SR.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: The estimated time from randomization to response and remission according to Hamilton Rating Scale for Depression (HAMD) total score.
time frame: From randomization to response and remission (24 week))
description: Response was defined as ≥50% decrease in the baseline HAMD total score; remission was defined as the HAMD total score ≤7
measure: The changes of Hamilton Rating Scale for Depression (HAMD) total score
time frame: From randomization to endpoint (Week 24)
description: To measure the change of the severity of depressive symptoms
measure: The incidence and nature of overall adverse events
time frame: From enrollment to endpoint (Week 24)
measure: The incidence and nature of drug-related adverse events
time frame: From enrollment to endpoint (Week 24)
measure: The number of subject withdrawal due to adverse events during double-blind phase
time frame: From randomization to endpoint(Week 24)
measure: The changes of Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR) total score
time frame: From randomization to endpoint (Week 24)
measure: The changes of Frequency, Intensity, and Burden of Side Effects-Rating (FIBSER)
time frame: From randomization to endpoint (Week 24)
description: The FIBSER is a self-report instrument assessing three domains of medication side effects within the past week
arm group label: measurement-based care
arm group type: Experimental
description: MBC allows psychiatrists to individualize treatment decisions for each patient based on the change of psychopathology and tolerance toward antidepressants. Treatment decisions were made by treating psychiatrists according to ratings of self-report scales obtained at each treatment visit. Paroxetine was started at 20mg/day and then raised to 30mg/day by week 4, 40mg/day by week 6, 50mg/day by week 8 and 60mg/day by week 10. Mirtazapine was started at 15mg/day and raised to 30mg/day by week 1 and 45mg/day by week 4. Dose adjustments were dependent on how long a patient had received a particular dose, symptom changes and side effects.
arm group label: Standard treatment
arm group type: Active Comparator
description: Patients in the ST group are treated by their psychiatrists according to their clinical needs as judged at each outpatient visit, receiving either open-label paroxetine (20-60mg/day) or mirtazapine (15-45mg/day) within the therapeutic dose range.
intervention type: Drug
intervention name: Paroxetine
description: Patients in both groups (MBC or ST) receive open-label paroxetine (20-60mg/day) within the therapeutic dose range recommended by the Guidelines for the Prevention and Treatment of Major Depression in China.
arm group label: Standard treatment
arm group label: measurement-based care
other name: Seroxat
intervention type: Drug
intervention name: Mirtazapine
description: Patients in both groups (MBC or ST) receive open-label mirtazapine (15-45mg/day) within the therapeutic dose range recommended by the Guidelines for the Prevention and Treatment of Major Depression in China
arm group label: Standard treatment
arm group label: measurement-based care
other name: Remeron
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Gang Wang, MD;PhD
role: Principal Investigator
affiliation: Beijing Anding Hospital, Capital Medical University
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Capital Medical University
investigator full name: Gang Wang
investigator title: vice-director of Affective Disorder Center, Beijing Anding Hospital
mesh term: Depressive Disorder
mesh term: Depression
mesh term: Depressive Disorder, Major
mesh term: Mirtazapine
mesh term: Paroxetine