<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/NCT02232555</url>
  </required_header>
  <id_info>
    <org_study_id>1208.10</org_study_id>
    <nct_id>NCT02232555</nct_id>
  </id_info>
  <brief_title>Study to Evaluate the Efficacy of Duloxetine in Outpatients With Major Depressive Disorder and Pain</brief_title>
  <official_title>A Ten-week, Randomized, Double-blind Study Evaluating the Efficacy of Duloxetine 60 mg Once Daily Versus Placebo in Outpatients With Major Depressive Disorder and Pain (EU-Pain Enriched Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      The purpose of this study was to investigate the efficacy of duloxetine versus placebo on&#xD;
      pain in outpatients with major depressive disorder (MDD): change in Brief Pain Inventory&#xD;
      Short Form (BPI-SF) 24-hour average pain score from baseline over the 8 weeks of treatment&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2005</start_date>
  <primary_completion_date type="Actual">May 2006</primary_completion_date>
  <phase>Phase 3</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 of 24-hour average pain rated on Brief Pain Inventory-Short Form (BPI-SF) score</measure>
    <time_frame>Up to 8 weeks after drug administration</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Montgomery-Asberg Depression Rating Scale (MADRS) total score</measure>
    <time_frame>Up to 8 weeks after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to sustained clinical response for Painful Physical Symptoms (PPS) according BPI-SF score</measure>
    <time_frame>Up to 8 weeks after drug administration</time_frame>
    <description>as defined by 30% reduction from baseline in question 5 (average pain) of the BPI-SF score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of patient symptoms rated on Symptom Checklist 90 Revised (SCL-90-R) scale</measure>
    <time_frame>Up to 8 weeks after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patients Global Impression (PGI) rated on PGI-improvement scale</measure>
    <time_frame>Up to 8 weeks after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Global Impressions (CGIs) by investigator rated on CGI-severity score</measure>
    <time_frame>Up to 8 weeks after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Global Impressions (CGIs) by investigator rated on CGI-improvement scale</measure>
    <time_frame>Up to 8 weeks after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to sustained clinical response for overall depression symptoms</measure>
    <time_frame>Up to 8 weeks after drug administration</time_frame>
    <description>as defined by a 50% reduction from baseline in MADRS score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>Up to 8 weeks after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients withdrawing due to adverse event</measure>
    <time_frame>Up to 8 weeks after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with clinical significant findings in vital signs</measure>
    <time_frame>Up to 8 weeks after drug administration</time_frame>
    <description>blood pressure, pulse rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with clinical significant findings in weight</measure>
    <time_frame>Up to 8 weeks after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with clinical significant findings in laboratory values</measure>
    <time_frame>Up to 8 weeks after drug administration</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment>327</enrollment>
  <condition>Depressive Disorder, Major</condition>
  <arm_group>
    <arm_group_label>Duloxetine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Duloxetine</intervention_name>
    <arm_group_label>Duloxetine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female outpatients who meet the criteria for MDD according to the Diagnostic&#xD;
             and Statistic Manual of mental disorders, 4th edition (DSM-IV) criteria and confirmed&#xD;
             by Mini International Neuropsychiatric Interview (MINI)&#xD;
&#xD;
          -  Montgomery-Asberg Depression Rating Scale (MADRS) score ≥20 at screening and baseline&#xD;
             (Visits 1 and 2)&#xD;
&#xD;
          -  Patients must have had at least one previous episode of depression in their medical&#xD;
             history&#xD;
&#xD;
          -  Painful physical symptoms (PPS) with a score ≥ 3 on the BPI-SF scale for average pain&#xD;
             at screening and baseline&#xD;
&#xD;
          -  Patient aged 18 years or older at the screening visit&#xD;
&#xD;
          -  CGI-Severity score ≥ 4 at Visits 1 and 2&#xD;
&#xD;
          -  Patients willing and able to comply with the scheduled visits, tests and procedures&#xD;
             required by the protocol&#xD;
&#xD;
          -  Written informed consent obtained at the screening visit, in accordance with Good&#xD;
             clinical practice (GCP) and local regulatory requirements, prior to any study&#xD;
             procedure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Neuro-psychiatric exclusions&#xD;
&#xD;
          -  Lack of response of the current episode to 2 or more adequate courses of&#xD;
             antidepressant therapy given at a clinically appropriate dose and for a sufficient&#xD;
             length of time in the judgement of the investigator&#xD;
&#xD;
          -  Any anxiety disorder as a primary diagnosis within the past 6 months (including panic&#xD;
             disorder, obsessive-compulsive disorder, posttraumatic stress disorder, generalized&#xD;
             anxiety disorder, and social phobia). Note: Specific phobias (i.e. agoraphobia,&#xD;
             arachnophobia, etc.) will be allowed&#xD;
&#xD;
          -  Any diagnosis of bipolar disorder, schizophrenia, or other psychotic disorders&#xD;
&#xD;
          -  Presence of an Axis II disorder which, in the judgement of the investigator, would&#xD;
             interfere with compliance with the study protocol&#xD;
&#xD;
          -  History of serious suicide attempt or patient judged to be at serious suicidal risk in&#xD;
             the opinion of the investigator and / or score &gt; 2 for question 10 (suicide) of the&#xD;
             MADRS&#xD;
&#xD;
          -  History of drug dependence, including alcohol or benzodiazepines, according to DSM-IV,&#xD;
             in the previous year&#xD;
&#xD;
          -  Positive urine screen for drug abuse (cannabis, benzodiazepines, barbiturates,&#xD;
             opiates, cocaine, amphetamines)&#xD;
&#xD;
        Other medical exclusions&#xD;
&#xD;
          -  Patients requiring continuous treatment with analgesics (&gt; step 2 WHO definition)&#xD;
             because of chronic pain (&gt; 6 months)&#xD;
&#xD;
          -  Patients with organic pain syndromes&#xD;
&#xD;
          -  Epilepsy or history of seizure disorder or of a treatment with anticonvulsant&#xD;
             medication for epilepsy or seizures&#xD;
&#xD;
          -  Patients with a known diagnosis of raised intraocular pressure or at risk of acute&#xD;
             narrow-angle glaucoma&#xD;
&#xD;
          -  Known diagnosis of congenital galactosaemia, glucose or galactose malabsorption&#xD;
             syndrome, or lactose deficiency&#xD;
&#xD;
          -  Patients with severely impaired renal function, defined by a creatinine clearance &lt; 30&#xD;
             mL/min (creatinine clearance was calculated by the central laboratory from the&#xD;
             screening safety laboratory test&#xD;
&#xD;
          -  Acute liver injury (such as hepatitis) or severe (Child-Pugh Class C) cirrhosis&#xD;
&#xD;
          -  Abnormal initial ECG findings according to investigator's judgement&#xD;
&#xD;
          -  Serious medical illness or clinically significant laboratory abnormalities which, in&#xD;
             the judgement of the investigator, are likely to require medication/ intervention or&#xD;
             hospitalization during the course of the study&#xD;
&#xD;
          -  Women of childbearing potential not using a medically accepted means of contraception&#xD;
             when engaging in sexual intercourse (e.g. intrauterine device, oral contraceptive,&#xD;
             contraceptive patch, implant, or barrier devices)&#xD;
&#xD;
          -  Women who are pregnant or breast-feeding&#xD;
&#xD;
        Pharmacological and other exclusions&#xD;
&#xD;
          -  Participation in another clinical trial within 30 days prior to screening (Visit 1)&#xD;
&#xD;
          -  Patients who have previously completed or withdrawn from this or any other study&#xD;
             investigating duloxetine or have previously been treated with duloxetine&#xD;
&#xD;
          -  Treatment with a monoamine oxidase inhibitor (MAOI) within 14 days prior to Visit 2 or&#xD;
             potential need to use a MAOI within 5 days after discontinuation of study drug&#xD;
&#xD;
          -  Treatment with fluoxetine within 28 days prior to Visit 2&#xD;
&#xD;
          -  Treatment with any of excluded medications (listed in Protocol) within 7 days prior to&#xD;
             Visit 2&#xD;
&#xD;
               -  (excepted MAOI within 14 days and fluoxetine within 28 days)&#xD;
&#xD;
          -  Frequent and/or severe allergic reactions with multiple medications. Known&#xD;
             hypersensitivity to duloxetine or any of the inactive ingredients&#xD;
&#xD;
          -  Electro-convulsive Therapy (ECT) or Transcranial Magnetic Stimulation (TMS) within one&#xD;
             year prior to screening&#xD;
&#xD;
          -  Initiation or discontinuation of depression-oriented psychotherapeutic treatment (e.g.&#xD;
             behavioural 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 study&#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 4, 2014</study_first_submitted>
  <study_first_submitted_qc>September 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2014</study_first_posted>
  <last_update_submitted>September 4, 2014</last_update_submitted>
  <last_update_submitted_qc>September 4, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 5, 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>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>Duloxetine Hydrochloride</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/NCT02232555
org study id: 1208.10
nct id: NCT02232555
lead sponsor: 
The purpose of this study was to investigate the efficacy of duloxetine versus placebo on
      pain in outpatients with major depressive disorder (MDD): change in Brief Pain Inventory
      Short Form (BPI-SF) 24-hour average pain score from baseline over the 8 weeks of treatment
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double
measure: Change of 24-hour average pain rated on Brief Pain Inventory-Short Form (BPI-SF) score
time frame: Up to 8 weeks after drug administration
measure: Change in Montgomery-Asberg Depression Rating Scale (MADRS) total score
time frame: Up to 8 weeks after drug administration
measure: Time to sustained clinical response for Painful Physical Symptoms (PPS) according BPI-SF score
time frame: Up to 8 weeks after drug administration
description: as defined by 30% reduction from baseline in question 5 (average pain) of the BPI-SF score
measure: Change of patient symptoms rated on Symptom Checklist 90 Revised (SCL-90-R) scale
time frame: Up to 8 weeks after drug administration
measure: Patients Global Impression (PGI) rated on PGI-improvement scale
time frame: Up to 8 weeks after drug administration
measure: Clinical Global Impressions (CGIs) by investigator rated on CGI-severity score
time frame: Up to 8 weeks after drug administration
measure: Clinical Global Impressions (CGIs) by investigator rated on CGI-improvement scale
time frame: Up to 8 weeks after drug administration
measure: Time to sustained clinical response for overall depression symptoms
time frame: Up to 8 weeks after drug administration
description: as defined by a 50% reduction from baseline in MADRS score
measure: Number of patients with adverse events
time frame: Up to 8 weeks after drug administration
measure: Number of patients withdrawing due to adverse event
time frame: Up to 8 weeks after drug administration
measure: Number of patients with clinical significant findings in vital signs
time frame: Up to 8 weeks after drug administration
description: blood pressure, pulse rate
measure: Number of patients with clinical significant findings in weight
time frame: Up to 8 weeks after drug administration
measure: Number of patients with clinical significant findings in laboratory values
time frame: Up to 8 weeks after drug administration
arm group label: Duloxetine
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Duloxetine
arm group label: Duloxetine
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
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: Depression
mesh term: Depressive Disorder, Major
mesh term: Duloxetine Hydrochloride