<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/NCT02229825</url>
  </required_header>
  <id_info>
    <org_study_id>1208.24</org_study_id>
    <nct_id>NCT02229825</nct_id>
  </id_info>
  <brief_title>Study to Assess Clinical Response of Duloxetine in Patients Hospitalized for Severe Depression</brief_title>
  <official_title>An Eight-week, Randomized, Double-blind, Two Parallel Groups, Study to Assess Clinical Response of Duloxetine 60 mg and 120 mg Per Day in Patients Hospitalized for Severe Depression.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      Study to assess efficacy of Duloxetine 120 mg and Duloxetine 60 mg in patients hospitalized&#xD;
      for severe depression after 4 weeks of treatment. To evaluate the rescue option in&#xD;
      non-responding patients. Safety of Duloxetine will also be assessed.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2007</start_date>
  <primary_completion_date type="Actual">August 2008</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>Double</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in the Montgomery-Asberg Depression Rating Scale (MADRS) total score</measure>
    <time_frame>baseline, week 4</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in the Hamilton Depression 6-item scale (HAMD-6) total score</measure>
    <time_frame>baseline, up to 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the MADRS total score</measure>
    <time_frame>baseline, up to 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in the MADRS and HAMD-6 total scores following dose up-titration</measure>
    <time_frame>4 weeks, up to 8 weeks</time_frame>
    <description>in patients that did not achieve minimum of 50 % response at primary endpoint</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of responders</measure>
    <time_frame>up to 8 weeks</time_frame>
    <description>defined as ≥ 50 % reduction of the MADRS and ≥ 50 % reduction of the HAMD-6 score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients reaching remission</measure>
    <time_frame>week 8</time_frame>
    <description>defined as a total MADRS score of ≤ 12</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reduction of Clinical Global Impressions scales of Severity of Illness (CGI-SI)</measure>
    <time_frame>up to 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in clinical Global Impressions of Improvement (CGI-I) score</measure>
    <time_frame>up to 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in patient Global Impressions of Improvement (PGI-I) score</measure>
    <time_frame>up to 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Hamilton Scale of Anxiety (HAMA) score</measure>
    <time_frame>up to 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reason for Living (RFL) questionnaire score</measure>
    <time_frame>up to 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Utilization of allowed hypnotic and anxiolytic comedication</measure>
    <time_frame>up to 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with treatment-emergent adverse events</measure>
    <time_frame>up to 10 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with clinically significant changes in vital signs</measure>
    <time_frame>up to 10 weeks</time_frame>
    <description>incl. weight</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with clinically significant changes in laboratory assessments</measure>
    <time_frame>up to 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of withdrawals due to adverse events</measure>
    <time_frame>up to 10 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">339</enrollment>
  <condition>Depressive Disorder, Major</condition>
  <arm_group>
    <arm_group_label>Duloxetine low</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Duloxetine high</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Duloxetine high</intervention_name>
    <arm_group_label>Duloxetine high</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Duloxetine low</intervention_name>
    <arm_group_label>Duloxetine low</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female patients of 18 years of age at the screening visit or older&#xD;
&#xD;
          2. Meet criteria for severe Major Depressive Disorder (MDD)&#xD;
&#xD;
          3. Montgomery-Asberg-depression rating scale (MADRS) total score ≥ 30 and the 6-item&#xD;
             Hamilton Depression scale (HAMD-6) score ≥12 at both screening (V1) visit and baseline&#xD;
             (V2) visits&#xD;
&#xD;
          4. Clinical Global Impression of Severity (CGI-Severity) score ≥4 at both screening visit&#xD;
             and baseline visit.&#xD;
&#xD;
          5. Requirement of hospitalization (not for social or other non-medical reasons) at&#xD;
             screening visit and at least up to Visit 4&#xD;
&#xD;
          6. Patient willing and able to comply with the requirement for hospitalization and with&#xD;
             all scheduled visits, tests and procedures required by the protocol&#xD;
&#xD;
          7. Have a level of understanding sufficient to provide informed consent and to&#xD;
             communicate with the investigators and site personnel. Informed consent document must&#xD;
             be signed at screening visit, in accordance with Good Clinical Practice (GCP) and&#xD;
             local regulatory requirements, prior to any study procedure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. More than two previous episodes of major depression that did not respond to adequate&#xD;
             doses and duration (minimum of 6 weeks) of two different antidepressant therapies&#xD;
&#xD;
          2. Lack of response to at least two antidepressant therapies given at adequate doses for&#xD;
             at least 6 weeks for the current depressive episode&#xD;
&#xD;
          3. Concurrent presence of symptoms fulfilling criteria for any Axis I disorder other than&#xD;
             anxiety disorders (with exception of the Obsessive-Compulsive Disorder (OCD)) or Major&#xD;
             Depressive Disorder, in the investigator's judgment&#xD;
&#xD;
          4. Any previous diagnosis of a bipolar disorder, schizophrenia or OCD&#xD;
&#xD;
          5. Depression with catatonic features, depression with post-partum onset, or organic&#xD;
             mental disorders&#xD;
&#xD;
          6. The presence of an Axis II disorder&#xD;
&#xD;
          7. MDD with psychotic features requiring neuroleptic treatment and/or interfering with&#xD;
             patient's ability to provide informed consent, at investigator's discretion&#xD;
&#xD;
          8. History of substance abuse or dependence within the past year, excluding nicotine and&#xD;
             caffeine, but including alcohol or benzodiazepines&#xD;
&#xD;
          9. Positive urine screen for drug abuse (cannabinoids, cocaine, opiates including&#xD;
             methadone, or amphetamines) at screening&#xD;
&#xD;
         10. Epilepsy or a history of seizure disorder or of a treatment with anticonvulsant&#xD;
             medication for epilepsy or seizures&#xD;
&#xD;
         11. Patients with acute liver injury (such as hepatitis) or severe cirrhosis (such as&#xD;
             Child-Pugh Class C)&#xD;
&#xD;
         12. Known diagnosis of congenital galactosaemia, glucose or galactose malabsorption&#xD;
             syndrome, or lactose deficiency&#xD;
&#xD;
         13. Patient with a known diagnosis of raised intraocular pressure, or at known risk of&#xD;
             acute narrow-angle glaucoma&#xD;
&#xD;
         14. Serious medical illness or clinically significant laboratory abnormalities that, in&#xD;
             the judgment of the investigator, are likely to require intervention/exclusion of&#xD;
             study medication during the course of the study: cardiovascular (e.g. uncontrolled&#xD;
             hypertension, abnormal initial ECG findings according to investigator judgement),&#xD;
             respiratory, haematological, hepatic or gastrointestinal&#xD;
&#xD;
         15. End stage renal disease (estimated creatinine clearance ≤30 mL/min) and undergoing&#xD;
             dialysis&#xD;
&#xD;
         16. Abnormal thyroid-stimulating hormone (TSH) concentrations, based on the performing&#xD;
             laboratory's reference ranges. Patients must be clinically and chemically euthyroid at&#xD;
             the time of randomization. Patients may be taking thyroid replacement therapy provided&#xD;
             their dose is stable and their compliance is good for at least three months before the&#xD;
             screening visit&#xD;
&#xD;
         17. Pregnancy (to be excluded by urine pregnancy test at screening visit) or&#xD;
             breast-feeding&#xD;
&#xD;
         18. Sexually active woman of childbearing potential (i.e. not 6 months post-menopausal, or&#xD;
             not surgically sterilized) not using a medically approved method of birth control&#xD;
             (i.e. oral contraceptives, intrauterine device, or double-barrier) for at least one&#xD;
             month prior to the screening visit and throughout the study&#xD;
&#xD;
         19. Participation in another clinical trial within 30 days prior to screening visit&#xD;
&#xD;
         20. Current treatment with Duloxetine for any indication and previous treatment with&#xD;
             Duloxetine for psychiatric indications&#xD;
&#xD;
         21. Known hypersensitivity to Duloxetine or any of the inactive ingredients&#xD;
&#xD;
         22. History of oversensitivity to psychotropic drugs, in the investigator's judgment&#xD;
&#xD;
         23. Electro-convulsive Therapy (ECT) or Transcranial Magnetic Stimulation (TMS) within one&#xD;
             year prior to screening visit and during the study&#xD;
&#xD;
         24. Initiation or discontinuation of depression-oriented psychotherapeutic treatment (e.g.&#xD;
             behaviour therapy, psychoanalytic therapy, cognitive therapy, etc) within 6 weeks&#xD;
             prior to screening visit, or planned use of such treatment at any time during the&#xD;
             study&#xD;
&#xD;
         25. Treatment with a Monoamine Oxidase Inhibitor (MAOI) within 14 days prior to baseline&#xD;
             visit or the potential need to use an MAOI during the study or within 5 days after&#xD;
             discontinuation of duloxetine&#xD;
&#xD;
         26. Treatment with Fluoxetine within 30 days prior to baseline visit&#xD;
&#xD;
         27. Treatment with any excluded medication listed in the protocol&#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>August 28, 2014</study_first_submitted>
  <study_first_submitted_qc>August 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 1, 2014</study_first_posted>
  <last_update_submitted>August 28, 2014</last_update_submitted>
  <last_update_submitted_qc>August 28, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 1, 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>
    <mesh_term>Depressive Disorder, Major</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Duloxetine Hydrochloride</mesh_term>
  </intervention_browse>
  <pending_results>
    <submitted>August 31, 2023</submitted>
  </pending_results>
  <!-- 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/NCT02229825
org study id: 1208.24
nct id: NCT02229825
lead sponsor: 
Study to assess efficacy of Duloxetine 120 mg and Duloxetine 60 mg in patients hospitalized
      for severe depression after 4 weeks of treatment. To evaluate the rescue option in
      non-responding patients. Safety of Duloxetine will also be assessed.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double
measure: Change in the Montgomery-Asberg Depression Rating Scale (MADRS) total score
time frame: baseline, week 4
measure: Change in the Hamilton Depression 6-item scale (HAMD-6) total score
time frame: baseline, up to 8 weeks
measure: Change in the MADRS total score
time frame: baseline, up to 8 weeks
measure: Changes in the MADRS and HAMD-6 total scores following dose up-titration
time frame: 4 weeks, up to 8 weeks
description: in patients that did not achieve minimum of 50 % response at primary endpoint
measure: Number of responders
time frame: up to 8 weeks
description: defined as ≥ 50 % reduction of the MADRS and ≥ 50 % reduction of the HAMD-6 score
measure: Number of patients reaching remission
time frame: week 8
description: defined as a total MADRS score of ≤ 12
measure: Reduction of Clinical Global Impressions scales of Severity of Illness (CGI-SI)
time frame: up to 8 weeks
measure: Change in clinical Global Impressions of Improvement (CGI-I) score
time frame: up to 8 weeks
measure: Change in patient Global Impressions of Improvement (PGI-I) score
time frame: up to 8 weeks
measure: Change in Hamilton Scale of Anxiety (HAMA) score
time frame: up to 8 weeks
measure: Reason for Living (RFL) questionnaire score
time frame: up to 8 weeks
measure: Utilization of allowed hypnotic and anxiolytic comedication
time frame: up to 8 weeks
measure: Number of patients with treatment-emergent adverse events
time frame: up to 10 weeks
measure: Number of patients with clinically significant changes in vital signs
time frame: up to 10 weeks
description: incl. weight
measure: Number of patients with clinically significant changes in laboratory assessments
time frame: up to 8 weeks
measure: Number of withdrawals due to adverse events
time frame: up to 10 weeks
arm group label: Duloxetine low
arm group type: Experimental
arm group label: Duloxetine high
arm group type: Experimental
intervention type: Drug
intervention name: Duloxetine high
arm group label: Duloxetine high
intervention type: Drug
intervention name: Duloxetine low
arm group label: Duloxetine low
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
mesh term: Depressive Disorder, Major
mesh term: Duloxetine Hydrochloride
submitted: August 31, 2023