<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/NCT02231268</url>
  </required_header>
  <id_info>
    <org_study_id>533.2</org_study_id>
    <nct_id>NCT02231268</nct_id>
  </id_info>
  <brief_title>Observational Study to Assess a 6-months Treatment With Gladem</brief_title>
  <official_title>Observational Study Via Internet to Assess a 6-months Treatment With GLADEM</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      -  Evaluation of a 6-months treatment with Gladem&#xD;
&#xD;
        -  Experiences with the internet for performing a postmarketing study (PMS) trial&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2000</start_date>
  <primary_completion_date type="Actual">January 2003</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>Change in Hamilton Depression Scale (HAMD-6)</measure>
    <time_frame>3 months, 6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Global assessment of efficacy on a 4-point scale</measure>
    <time_frame>up to 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global assessment of compliance on a 4-point scale</measure>
    <time_frame>up to 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global assessment of tolerability on a 4-point scale</measure>
    <time_frame>up to 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical global impression score</measure>
    <time_frame>up to 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of responders</measure>
    <time_frame>up to 6 months</time_frame>
    <description>&gt;= 50 % reduction in HAMD-6 score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in HAMD subscores</measure>
    <time_frame>baseline, 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse drug reactions</measure>
    <time_frame>up to 6 months</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">546</enrollment>
  <condition>Depressive Disorder</condition>
  <arm_group>
    <arm_group_label>Depressive patients</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gladem</intervention_name>
    <arm_group_label>Depressive patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        out-patients&#xD;
      </textblock>
    </study_pop>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women at least 18 years old&#xD;
&#xD;
          -  De novo prescription of Gladem&#xD;
&#xD;
          -  Treatment with Gladem intended for at least 6 months&#xD;
&#xD;
          -  Depressive disorders&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known hypersensitivity against sertraline&#xD;
&#xD;
          -  Concomitant treatment with monoamine oxidase (MAO)-inhibitors, selegiline, moclobemide&#xD;
             (washout for at least 14 days necessary)&#xD;
&#xD;
          -  Concomitant treatment with other serotoninergic substances like tryptophan or&#xD;
             fenfluramine&#xD;
&#xD;
          -  Instable epilepsy&#xD;
&#xD;
        According to product information (October 1998) Gladem prescription was possible with&#xD;
        precautions in the following cases:&#xD;
&#xD;
          -  Patients with stable epilepsy&#xD;
&#xD;
          -  Patients with restricted liver functions&#xD;
&#xD;
          -  Suicidal patients&#xD;
&#xD;
          -  Patients in emotional state and marked sleeping disorders&#xD;
&#xD;
        According to product information (October 1998) Gladem should only be prescribed during&#xD;
        pregnancy and lactation period, if the expected benefit was greater than the risk. Women of&#xD;
        childbearing age should use Gladem only in combination with sufficient contraception.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <link>
    <url>http://trials.boehringer-ingelheim.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>September 2, 2014</study_first_submitted>
  <study_first_submitted_qc>September 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 4, 2014</study_first_posted>
  <last_update_submitted>September 2, 2014</last_update_submitted>
  <last_update_submitted_qc>September 2, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 4, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depressive Disorder</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/NCT02231268
org study id: 533.2
nct id: NCT02231268
lead sponsor: 
-  Evaluation of a 6-months treatment with Gladem

        -  Experiences with the internet for performing a postmarketing study (PMS) trial
observational model: Cohort
time perspective: Prospective
measure: Change in Hamilton Depression Scale (HAMD-6)
time frame: 3 months, 6 months
measure: Global assessment of efficacy on a 4-point scale
time frame: up to 6 months
measure: Global assessment of compliance on a 4-point scale
time frame: up to 6 months
measure: Global assessment of tolerability on a 4-point scale
time frame: up to 6 months
measure: Clinical global impression score
time frame: up to 6 months
measure: Number of responders
time frame: up to 6 months
description: >= 50 % reduction in HAMD-6 score
measure: Change in HAMD subscores
time frame: baseline, 6 months
measure: Number of patients with adverse drug reactions
time frame: up to 6 months
arm group label: Depressive patients
intervention type: Drug
intervention name: Gladem
arm group label: Depressive patients
study pop: 
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor
mesh term: Depressive Disorder