<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/NCT01696617</url>
  </required_header>
  <id_info>
    <org_study_id>031-KOC-1108i</org_study_id>
    <nct_id>NCT01696617</nct_id>
  </id_info>
  <brief_title>Aripiprazole (Abilify®) as an Adjunctive Treatment for Inadequate Response in Major Depressive Disorder</brief_title>
  <official_title>Aripiprazole (Abilify®) as an Adjunctive Treatment for Inadequate Response in Major Depressive Disorder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Otsuka Pharmaceutical Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators hypothesized that combined pharmacotherapy using adjunctive aripiprazole of&#xD;
      standard antidepressants would be associated with improved depression response in Major&#xD;
      depressive disorder, especially in Quality of life.&#xD;
&#xD;
      The investigators compare the mean changes in the quality of life between before add-on and 8&#xD;
      weeks treatment of aripiprazole and between before add-on and 6 weeks treatment of&#xD;
      aripiprazole.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Previous study about quality of life measurement in patients with depression have been&#xD;
      reported that quality of life have to be measured irrespective with the severity of&#xD;
      depression because quality of life has some other aspect to depression.The investigators have&#xD;
      designed a 6-week single blinded study with flexible dose aripiprazole augmentation, ranging&#xD;
      from 2.5mg to maximum 20 mg (15mg for patients on fluoxetine or paroxetine), in patients who&#xD;
      responded inadequately (a score of &gt;18 on the MADRS) to first-line antidepressant&#xD;
      pharmacotherapy. The investigators compare the mean changes from in the quality of life at 8&#xD;
      weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 10, 2012</start_date>
  <completion_date type="Actual">February 2019</completion_date>
  <primary_completion_date type="Actual">December 2016</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Quality of Life Scale (QOLS)</measure>
    <time_frame>Change from Baseline at 8 weeks</time_frame>
    <description>change of Quality of Life Scale (QOLS)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Montgomery-Åsberg Depression Rating Scale</measure>
    <time_frame>Change from Baseline at 8 weeks</time_frame>
    <description>change of Montgomery-Åsberg Depression Rating Scale</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Hamilton Rating Scale for Depression</measure>
    <time_frame>Change from Baseline at 8 weeks</time_frame>
    <description>change of Hamilton Rating Scale for Depression</description>
  </other_outcome>
  <other_outcome>
    <measure>Clinical Global Impression-severity, Clinical Global Impression-Improvement</measure>
    <time_frame>Change from Baseline at 8 weeks</time_frame>
    <description>change of Clinical Global Impression-severity, Clinical Global Impression-Improvement</description>
  </other_outcome>
  <other_outcome>
    <measure>Beck Depression Inventory</measure>
    <time_frame>Change from Baseline at 8 weeks</time_frame>
    <description>change of Beck Depression Inventory</description>
  </other_outcome>
  <other_outcome>
    <measure>Inventory of Depressive Symptomatology Self-Report Scale</measure>
    <time_frame>Change from Baseline at 8 weeks</time_frame>
    <description>change of Inventory of Depressive Symptomatology Self-Report Scale</description>
  </other_outcome>
  <other_outcome>
    <measure>Drug - Induced Extrapyramidal Symptoms Scale</measure>
    <time_frame>Change from Baseline at 8 weeks</time_frame>
    <description>change of Drug - Induced Extrapyramidal Symptoms Scale</description>
  </other_outcome>
  <other_outcome>
    <measure>The Liverpool University Neuroleptic Side Effect Rating Scale</measure>
    <time_frame>Change from Baseline at 8 weeks</time_frame>
    <description>change of The Liverpool University Neuroleptic Side Effect Rating Scale</description>
  </other_outcome>
  <other_outcome>
    <measure>Short From-36 Health survey</measure>
    <time_frame>Change from Baseline at 8 weeks</time_frame>
    <description>change of Short From-36 Health survey</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">46</enrollment>
  <condition>Major Depressive Disorder</condition>
  <arm_group>
    <arm_group_label>Aripiprazole 8-week group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Adjunctive aripiprazole 8-week treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Aripiprazole 6-week group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Adjunctive aripiprazole 6-week treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Aripiprazole 6-week group</intervention_name>
    <arm_group_label>Aripiprazole 8-week group</arm_group_label>
    <other_name>Abilify®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Aripiprazole 8-week group</intervention_name>
    <arm_group_label>Aripiprazole 6-week group</arm_group_label>
    <other_name>Abilify®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age : 18-65&#xD;
&#xD;
          -  Patients with major depressive disorder according to DSM-IV criteria that have lasted&#xD;
             &gt;8 weeks&#xD;
&#xD;
          -  MADRS total score of 18 or higher&#xD;
&#xD;
          -  Patients who responded inadequately (a score of &gt;18 on the MADRS) to first-line&#xD;
             antidepressant treatment of 4 week duration&#xD;
&#xD;
          -  Current use of standard antidepressant treatment in monotherapy or combination of 2&#xD;
             antidepressants : escitalopram (10 - 20mg/d), fluoxetine(20 - 40mg/d), paroxetine&#xD;
             CR(25 - 50mg/d), sertraline(100 - 150mg/d), mirtazapine (15 - 45mg/d), duloxetine (30&#xD;
             - 60mg/d) or venlafaxine ER(150-225mg/d)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Past history of hypersensitivity to aripiprazole&#xD;
&#xD;
          -  Primary diagnosis of MDD with psychotic feature, bipolar disorder, schizophrenia,&#xD;
             schizoaffective disorder, other psychotic disorder or anxiety disorder, a history of&#xD;
             alcohol/ drug abuse within the past 12 months, or a diagnosis of dementia&#xD;
&#xD;
          -  Clinically significant current Axis II (DSM-IV-TR) diagnosis&#xD;
&#xD;
          -  A significant risk of suicide corroborated by a score of ≥5 on item 10(suicidal&#xD;
             thoughts) on the MADRS scale or by clinical judgment of the investigator&#xD;
&#xD;
          -  Pregnancy or in breast-feeding&#xD;
&#xD;
          -  Presence of a serious medical illness including cardiac, hepatic, renal, respiratory,&#xD;
             endocrinologic, neurologic, or hematologic disease or physical disorder judged to&#xD;
             significantly affect central nervous system function&#xD;
&#xD;
          -  Patients taking antipsychotics, mood stabilizer or any psychotropic medications&#xD;
             besides antidepressants, except benzodiazepines or beta blockers or hypnotics&#xD;
&#xD;
          -  Patients with past treatment failures of aripiprazole&#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>Yong Min Ahn, MD. Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>110-744</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>July 31, 2012</study_first_submitted>
  <study_first_submitted_qc>September 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2012</study_first_posted>
  <last_update_submitted>April 8, 2019</last_update_submitted>
  <last_update_submitted_qc>April 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 9, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Yong Min Ahn</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <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>Aripiprazole</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/NCT01696617
org study id: 031-KOC-1108i
nct id: NCT01696617
lead sponsor: 
collaborator: 
has dmc: Yes
The investigators hypothesized that combined pharmacotherapy using adjunctive aripiprazole of
      standard antidepressants would be associated with improved depression response in Major
      depressive disorder, especially in Quality of life.

      The investigators compare the mean changes in the quality of life between before add-on and 8
      weeks treatment of aripiprazole and between before add-on and 6 weeks treatment of
      aripiprazole.
Previous study about quality of life measurement in patients with depression have been
      reported that quality of life have to be measured irrespective with the severity of
      depression because quality of life has some other aspect to depression.The investigators have
      designed a 6-week single blinded study with flexible dose aripiprazole augmentation, ranging
      from 2.5mg to maximum 20 mg (15mg for patients on fluoxetine or paroxetine), in patients who
      responded inadequately (a score of >18 on the MADRS) to first-line antidepressant
      pharmacotherapy. The investigators compare the mean changes from in the quality of life at 8
      weeks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Quality of Life Scale (QOLS)
time frame: Change from Baseline at 8 weeks
description: change of Quality of Life Scale (QOLS)
measure: Montgomery-Åsberg Depression Rating Scale
time frame: Change from Baseline at 8 weeks
description: change of Montgomery-Åsberg Depression Rating Scale
measure: Hamilton Rating Scale for Depression
time frame: Change from Baseline at 8 weeks
description: change of Hamilton Rating Scale for Depression
measure: Clinical Global Impression-severity, Clinical Global Impression-Improvement
time frame: Change from Baseline at 8 weeks
description: change of Clinical Global Impression-severity, Clinical Global Impression-Improvement
measure: Beck Depression Inventory
time frame: Change from Baseline at 8 weeks
description: change of Beck Depression Inventory
measure: Inventory of Depressive Symptomatology Self-Report Scale
time frame: Change from Baseline at 8 weeks
description: change of Inventory of Depressive Symptomatology Self-Report Scale
measure: Drug - Induced Extrapyramidal Symptoms Scale
time frame: Change from Baseline at 8 weeks
description: change of Drug - Induced Extrapyramidal Symptoms Scale
measure: The Liverpool University Neuroleptic Side Effect Rating Scale
time frame: Change from Baseline at 8 weeks
description: change of The Liverpool University Neuroleptic Side Effect Rating Scale
measure: Short From-36 Health survey
time frame: Change from Baseline at 8 weeks
description: change of Short From-36 Health survey
arm group label: Aripiprazole 8-week group
arm group type: Experimental
description: Adjunctive aripiprazole 8-week treatment
arm group label: Aripiprazole 6-week group
arm group type: Active Comparator
description: Adjunctive aripiprazole 6-week treatment
intervention type: Drug
intervention name: Aripiprazole 6-week group
arm group label: Aripiprazole 8-week group
other name: Abilify®
intervention type: Drug
intervention name: Aripiprazole 8-week group
arm group label: Aripiprazole 6-week group
other name: Abilify®
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Yong Min Ahn, MD. Ph.D.
role: Principal Investigator
affiliation: Seoul National University Hospital
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Yong Min Ahn
investigator title: Professor
mesh term: Depressive Disorder
mesh term: Depression
mesh term: Depressive Disorder, Major
mesh term: Aripiprazole