Efficacy Study of Vortioxetine (Lu AA21004) for Treatment of Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Vortioxetine; Placebo
Intervention description: Vortioxetine tablets; Vortioxetine placebo
Intervention MeSH terms: Vortioxetine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 366.0
Sex: All
Minimum age: 20 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Drug Therapy

Summary:

      The purpose of this study is to assess the efficacy, safety and tolerability of 8-week
      treatment with Vortioxetine (Lu AA21004), once daily (QD), in Japanese participants with
      major depressive disorder.

      The purpose of this study is to assess the efficacy, safety and tolerability of 8-week
      treatment with Lu AA21004, once daily (QD), in Japanese participants with major depressive
      disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          1. The subject suffers from Major Depressive Disorder (MDD) as the primary diagnosis
             according to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition,
             Text Revision (DSM-IV-TR) criteria (classification code 296.2x and 296.3x).

          2. The reported duration of the current major depressive episode is at least 3 months at
             the Screening Visit.

          3. The subject has a Montgomery-Åsberg Depression Rating Scale (MADRS) total score ≥26 at
             the Screening and Baseline Visits.

          4. The subject has a Clinical Global Impression Scale-Severity (CGI-S) score ≥4 at the
             Screening and Baseline Visits

        Exclusion Criteria:

          1. The subject has one or more of the following conditions:

               -  Any current psychiatric disorder other than MDD as defined in the DSM-IV-TR. A
                  subject who exhibits symptoms of anxiety is eligible unless the subject fulfills
                  the diagnostic criteria for a current anxiety disorder per DSM-IV-TR.

               -  Current diagnosis or history of manic or hypomanic episode, schizophrenia or any
                  other psychotic disorder, including major depression with psychotic features,
                  mental retardation, organic mental disorders, or mental disorders due to a
                  general medical condition as defined in the DSM-IV-TR.

               -  Current diagnosis or history of any substance-related disorder (except nicotine
                  and caffeine-related disorders) as defined in the DSM-IV-TR.

               -  Presence or history of a clinically significant neurological disorder (including
                  epilepsy).

               -  Neurodegenerative disorder (Alzheimer's disease, Parkinson's disease, multiple
                  sclerosis, Huntington's disease, etc.).

               -  Any DSM-IV-TR axis II disorder that might compromise the study.

          2. The current depressive symptoms of the subject are considered by the investigator to
             have been resistant to 2 adequate antidepressant treatments of at least 6 weeks
             duration each.

          3. The subject is at significant risk of suicide or has a score ≥5 on Item 10 (suicidal
             thoughts) of the MADRS at the Screening and Baseline Visit, or has attempted suicide
             within 6 months prior to the Screening Visit.