<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/NCT03278938</url>
  </required_header>
  <id_info>
    <org_study_id>#5723</org_study_id>
    <nct_id>NCT03278938</nct_id>
  </id_info>
  <brief_title>Add-on to Cognitive, Event-Related Potentials (ERP) and Electroencephalogram (EEG) Asymmetry in Affective Disorders</brief_title>
  <official_title>Add-on to Cognitive, ERP and EEG Asymmetry in Affective Disorders (#6559R) [Formerly #5723]</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>New York State Psychiatric Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>New York State Psychiatric Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Depressed patients unremitted after monotherapy with citalopram or bupropion will remit&#xD;
      following six weeks treatment with the combination of citalopram and bupropion.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants in another study who did not remit during 12 weeks treatment with citalopram (to&#xD;
      40 mg/d) or bupropion (to 450 mg/d) will have citalopram (to 40 mg/d) or bupropion (to 450&#xD;
      mg/d) added for six weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    PI Retired and no data was collected&#xD;
  </why_stopped>
  <start_date type="Anticipated">June 29, 2012</start_date>
  <completion_date type="Anticipated">January 2016</completion_date>
  <primary_completion_date type="Anticipated">January 2016</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>treatment in this study was determined by treatment received in prior study; i.e., those who had received escitalopram then receive escitalopram + bupropion; those initially taking bupropion then receive escitalopram + bupropion</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hamilton Rating Scale</measure>
    <time_frame>weeks 6</time_frame>
    <description>Decrease in score for Hamilton Rating Scale for Depression, 17-item version</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Depressive Illness</condition>
  <arm_group>
    <arm_group_label>bupropion added to citalopram</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>patients who did not remit with citalopram will continue at the same dose and have bupropion added</description>
  </arm_group>
  <arm_group>
    <arm_group_label>citalopram added to bupropion</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients who did not remit with bupropion will have bupropion continued at the same dose and citalopram will be added</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>bupropion</intervention_name>
    <description>FDA approved drug for treating depression</description>
    <arm_group_label>bupropion added to citalopram</arm_group_label>
    <arm_group_label>citalopram added to bupropion</arm_group_label>
    <other_name>Wellbutrin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>citalopram</intervention_name>
    <description>FDA approved treatment for depression</description>
    <arm_group_label>bupropion added to citalopram</arm_group_label>
    <arm_group_label>citalopram added to bupropion</arm_group_label>
    <other_name>Celexa</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  non-remission in Protocol #6559R&#xD;
&#xD;
          -  age 18-66&#xD;
&#xD;
          -  signs informed consent&#xD;
&#xD;
          -  physically healthy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  bipolar disorder&#xD;
&#xD;
          -  history of psychosis&#xD;
&#xD;
          -  history of anorexia nervosa or bulimia&#xD;
&#xD;
          -  history of seizure disorder, significant brain trauma or other medical reason to&#xD;
             suspect increased seizure risk&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>66 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jonathan W Stewart, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Research Psychiatrist II at New York State Psychiatric Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>New York State Psychiatric Institute</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.depression-nyc.org</url>
    <description>web site for the Depression Evaluation Service, New York State Psychiatric Institute</description>
  </link>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>May 16, 2013</study_first_submitted>
  <study_first_submitted_qc>September 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <last_update_submitted>March 13, 2019</last_update_submitted>
  <last_update_submitted_qc>March 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>depression</keyword>
  <keyword>citalopram</keyword>
  <keyword>bupropion</keyword>
  <keyword>combination therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mood Disorders</mesh_term>
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bupropion</mesh_term>
    <mesh_term>Citalopram</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/NCT03278938
org study id: #5723
nct id: NCT03278938
lead sponsor: 
has dmc: No
Depressed patients unremitted after monotherapy with citalopram or bupropion will remit
      following six weeks treatment with the combination of citalopram and bupropion.
Participants in another study who did not remit during 12 weeks treatment with citalopram (to
      40 mg/d) or bupropion (to 450 mg/d) will have citalopram (to 40 mg/d) or bupropion (to 450
      mg/d) added for six weeks.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: treatment in this study was determined by treatment received in prior study; i.e., those who had received escitalopram then receive escitalopram + bupropion; those initially taking bupropion then receive escitalopram + bupropion
primary purpose: Treatment
masking: None (Open Label)
measure: Hamilton Rating Scale
time frame: weeks 6
description: Decrease in score for Hamilton Rating Scale for Depression, 17-item version
arm group label: bupropion added to citalopram
arm group type: Active Comparator
description: patients who did not remit with citalopram will continue at the same dose and have bupropion added
arm group label: citalopram added to bupropion
arm group type: Active Comparator
description: Patients who did not remit with bupropion will have bupropion continued at the same dose and citalopram will be added
intervention type: Drug
intervention name: bupropion
description: FDA approved drug for treating depression
arm group label: bupropion added to citalopram
arm group label: citalopram added to bupropion
other name: Wellbutrin
intervention type: Drug
intervention name: citalopram
description: FDA approved treatment for depression
arm group label: bupropion added to citalopram
arm group label: citalopram added to bupropion
other name: Celexa
criteria: 
gender: All
minimum age: 18 Years
maximum age: 66 Years
healthy volunteers: No
last name: Jonathan W Stewart, MD
role: Principal Investigator
affiliation: Research Psychiatrist II at New York State Psychiatric Institute
facility: 
country: United States
url: http://www.depression-nyc.org
description: web site for the Depression Evaluation Service, New York State Psychiatric Institute
responsible party type: Sponsor
mesh term: Mood Disorders
mesh term: Depression
mesh term: Depressive Disorder
mesh term: Bupropion
mesh term: Citalopram