A Duloxetine Dosing Strategy Study in Korean Patients With Major Depressive Disorder
Condition: Major Depressive Disorder (MDD)
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Duloxetine hydrochloride
Intervention description: po, QD
Intervention MeSH terms: Duloxetine Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 249.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess nausea severity in response to four different drug
      dosing strategies of Duloxetine (30 mg with food, 60 mg with food, 30 mg without food, and 60
      mg without food) in Korean patients with major depressive disorder (MDD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  For females of child-bearing potential test negative for pregnancy at the time of
             enrollment based on a urine pregnancy test and agree to use a reliable method of birth
             control during the study and for 1 month following the last dose of study drug.

          -  17-item Hamilton Depression Rating Scale (HAMD-17) total score >15 at Screening and
             Randomization

          -  Have signed the informed consent document (ICD)

          -  Have a level of understanding sufficient to provide informed consent and to
             communicate with the investigators and site personnel

          -  Are judged to be reliable and agree to keep all appointments for clinic visits, tests,
             and procedures required by the protocol

          -  Patients must meet Diagnostic and Statistical Manual of Mental Disorders-fourth
             edition-text revision (DSM-IV-TR) criteria for Major Depressive Disorder (MDD). The
             Mini International Neuropsychiatric Interview (MINI) will be used to establish the
             diagnosis and exclude other psychiatric illnesses.

        Exclusion Criteria:

          -  Treatment within the last 30 days with a drug that has not received regulatory
             approval for any indication at the time of study entry

          -  Have any current primary Axis I disorder other than MDD

          -  Have any previous diagnosis of bipolar disorder, schizophrenia, or other psychotic
             disorders

          -  Lack of response of the current episode of major depression to two or more adequate
             courses of antidepressant therapy at clinically appropriate dose for a minimum of 4
             weeks or, in the judgment of the investigator, the patient meets criteria for
             treatment-resistant depression

          -  Have a history of a lack of response, at any time, to an adequate trial of duloxetine
             (defined as treatment with at least 60 mg/day of duloxetine for a minimum of 4 weeks)

          -  Presence of an Axis II disorder that, in the judgment of the investigator, would
             interfere with study compliance

          -  DSM-IV-TR-defined history of substance abuse or dependence within the past 6 months,
             excluding nicotine and caffeine

          -  Patients judged to be at serious suicidal risk in the opinion of the investigator
             and/or score ≥3 on Item 3 (suicide) of the HAMD-17

          -  Serious medical illness or clinically significant laboratory abnormalities that, in
             the judgment of the investigator, are likely to require
             intervention/hospitalization/excluded medication during the course of the study Note:
             Patients with acute liver injury (such as hepatitis) or severe (Child-Pugh Class C)
             cirrhosis will be excluded

          -  Have an acute or chronic medical illness with the main symptoms of nausea or
             gastrointestinal discomfort or taking any medication known to have major gastric
             effects that would interfere with nausea ratings.

          -  Electroconvulsive therapy (ECT) or Transcranial Magnetic Stimulation (TMS) within the
             past year

          -  Taking any excluded medications within 7 days prior to Randomization.

          -  Treatment with a monoamine oxidase inhibitor (MAOI) within 14 days prior to
             Randomization or potential need to use a MAOI within 5 days after discontinuation of
             study drug.

          -  Treatment with fluoxetine within 30 days prior to Randomization.

          -  Frequent and/or severe allergic reactions with multiple medications or known
             hypersensitivity to duloxetine.

          -  Abnormal thyroid stimulating hormone (TSH) concentration. Note: Participants diagnosed
             with hyperthyroidism or hypothyroidism who were treated with a stable dose of thyroid
             supplement for at least the past 3 months, have medically appropriate TSH
             concentration, and are clinically euthyroid, are allowed to enroll in this study.