Efficacy and Safety 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: 462.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Major Depressive Disorder; Depression; Melancholia; Drug Therapy

Summary:

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

Eligibility criteria:

        Inclusion Criteria:

          -  Suffers from a major depressive episode recurrent as the primary diagnosis according
             to the American Psychiatric Association Diagnostic and Statistical Manual of Mental
             Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria.

          -  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 previously participated in a Lu AA21004 clinical study.

          -  Has 1 or more the following:

               -  Any current psychiatric disorder other than Major Depressive Disorder as defined
                  in the DSM-IV

               -  Current or past history of: manic or hypomanic episode, schizophrenia or any
                  other psychotic disorder defined in the DSM-IV-TR.

               -  Diagnosis of alcohol or other substance disorder (except nicotine and caffeine)
                  as defined in the DSM-IV-TR that has not been in sustained full remission for at
                  least years prior to screening (participant must also have negative urine drug
                  screen prior to Baseline).

               -  Presence or history of a clinically significant neurological disorder (including
                  epilepsy)

               -  Neurodegenerative disorder.

               -  Any Axis II disorder that might compromise the study.

          -  Has a thyroid stimulating hormone value outside the normal range at the Screening
             Visit that is deemed clinically significant by the investigator.

          -  Has clinically significant abnormal vital signs as determined by the investigator.

          -  Has an abnormal Electrocardiogram.

          -  Has an alanine aminotransferase, aspartate aminotransferase or total bilirubin level
             greater than 1.5 times the upper limits of normal.

          -  Has a previous history of cancer that had been in remission for less than 5 years
             prior to the first dose of study medication.

          -  Has a disease or takes medication that, in the opinion of the investigator, could
             interfere with the assessments of safety, tolerability, or efficacy.

          -  Has a known history of or currently has increased intraocular pressure or is at risk
             of acute narrow-angle glaucoma.

          -  Has a clinically significant unstable illness, for example, hepatic impairment or
             renal insufficiency, or a cardiovascular, pulmonary, gastrointestinal, endocrine,
             neurological, rheumatologic, immunologic, infectious, skin and subcutaneous tissue
             disorders, or metabolic disturbance. For the purposes of this protocol the following
             conditions are considered unstable due to the potential impact on assessment of MDD
             response: pain disorder, chronic fatigue syndrome, fibromyalgia, and obstructive sleep
             apnea.

          -  Has a significant risk of suicide according to the investigator's opinion.