Efficacy and Safety of Vortioxetine (Lu AA21004) in the Treatment of Patients With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Vortioxetine; Duloxetine; Placebo
Intervention description: Encapsulated vortioxetine immediate-release tablets; Duloxetine capsules; Placebo-matching capsules
Intervention MeSH terms: Duloxetine Hydrochloride; Vortioxetine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 611.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Major Depressive Disorder; Depression; Drug Therapy; Major Depressive Episode

Summary:

      The purpose of this study is to determine the efficacy and safety of vortioxetine, once daily
      (QD), in adults with major depressive disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Suffers from a major depressive episode as the primary diagnosis according to
             Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision
             (DSM-IV-TR) criteria.

          -  The reported duration of the current major depressive episode is at least 3 months.

        Exclusion Criteria:

          -  Has 1 or more the following:

               -  Any current psychiatric disorder other than major depressive disorder as defined
                  in the DSM-IV-TR.

               -  Current or past 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.

               -  Any substance disorder (except nicotine and caffeine) within the previous 6
                  months as defined in the DSM-IV-TR.

               -  Presence or history of a clinically significant neurological disorder (including
                  epilepsy).

               -  Neurodegenerative disorder (Alzheimer disease, Parkinson disease, multiple
                  sclerosis, Huntington disease, etc).

               -  Any Axis II disorder that might compromise the study.

          -  Has a significant risk of suicide according to the investigator's opinion or has a
             score ≥5 on item 10 (suicidal thoughts) of the Montgomery Åsberg Depression Rating
             Scale (MADRS) or has made a suicide attempt in the previous 6 months.

          -  The current depressive symptoms of the patient are considered by the investigator to
             have been resistant to 2 adequate antidepressant treatments of at least 6 weeks
             duration each.

          -  Has received electroconvulsive therapy within 6 months prior to Screening.

          -  Is currently receiving formal cognitive or behavioral therapy, systematic
             psychotherapy, or plans to initiate such therapy during the study.