Safety and Efficacy Study of Vortioxetine (Lu AA21004) in Adults With Major Depressive Disorder
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Vortioxetine; Placebo
Intervention description: Encapsulated vortioxetine immediate release tablets; Vortioxetine placebo-matching capsules
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: 469.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Major Depressive Disorder; Depression; Drug Therapy

Summary:

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

Eligibility criteria:

        Inclusion Criteria:

          -  Suffers from a major depressive episode (MDE) recurrent as the primary diagnosis
             according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth
             Edition, Text Revision (DSM-IV-TR) criteria.

          -  The reported duration of the current MDE is at least 3 months.

          -  Has a Montgomery Åsberg Depression Rating Scale (MADRS) total score of 26 or greater
             at Screening and Baseline Visits.

          -  Has a Clinical Global Impression - Severity of Illness (CGI-S) score of 4 or greater
             at Screening and Baseline Visits.

        Exclusion Criteria:

          -  Has received any investigational compound <30 days before Screening or 5 half-lives
             prior to Screening.

          -  Has received Lu AA21004 in a previous clinical study.

          -  Has 1 or more the following:

               1. Any current psychiatric disorder other than MDD as defined in the DSM-IV-TR .

               2. Current 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.

               3. Diagnosis of alcohol or other substance abuse or dependence (excluding nicotine
                  or caffeine) as defined in the DSM-IV-TR that had not been in sustained full
                  remission for at least 2 years prior to Screening.

               4. Presence or history of a clinically significant neurological disorder (including
                  epilepsy).

               5. Neurodegenerative disorder (Alzheimer disease, Parkinson disease, multiple
                  sclerosis, Huntington disease, etc).

               6. Any Axis II disorder that might compromise the study.

          -  The current depressive symptoms of the patient were considered by the investigator to
             have been resistant to 2 adequate antidepressant treatments of at least 6 weeks
             duration each.

          -  Has received electroconvulsive therapy, vagal nerve stimulation, or repetitive
             transcranial magnetic stimulation within 6 months prior to Screening.

          -  Was currently receiving formal cognitive or behavioral therapy, systematic
             psychotherapy, or planned to initiate such therapy during the study.

          -  Has a significant risk of suicide according to the investigator's clinical judgment or
             had a score ≥5 on item 10 (suicidal thoughts) of the MADRS or had made a suicide
             attempt in the previous 6 months.

          -  Was required to take excluded medications or it was anticipated that would require
             treatment with at least 1 of the disallowed concomitant medications during the study.

          -  Has a clinically significant unstable illness, for example hepatic impairment or renal
             insufficiency, or a cardiovascular, pulmonary, gastrointestinal, endocrine,
             neurological, rheumatologic, immunologic, hematological, infectious, dermatological
             disorder or metabolic disturbance. NOTE: For the purposes of this study, the following
             conditions were considered unstable due to the potential impact on assessment of MDD
             response: pain disorder, chronic fatigue syndrome, fibromyalgia, and obstructive sleep
             apnea.

          -  Has 1 or more laboratory value outside the normal range, based on the blood or urine
             samples taken at the Screening Visit, that were considered by the investigator to be
             clinically significant; or the patient has any of the following values at the
             Screening Visit:

               1. A serum creatinine value >1.5 times the upper limits of normal (× ULN).

               2. A total serum total bilirubin value >1.5 × ULN.

               3. A serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value
                  >2 × ULN.

          -  Has a thyroid stimulating hormone value outside the normal range.

          -  Has clinically significant abnormal vital signs.

          -  Has an abnormal electrocardiogram.