Efficacy Study of Vortioxetine (Lu AA21004) in Adults With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Vortioxetine; Placebo
Intervention description: Encapsulated immediate-release vortioxetine 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: Double (Participant, Investigator)
Enrollment: 560.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Depression; Depressive Disorder; Mood Disorder; Mental Disorder; Melancholia, Involutional; Paraphrenia, Involutional; Drug Therapy

Summary:

      The purpose of this study is to determine the effectiveness and safety of vortioxetine, once
      daily (QD), in patients with Major Depressive Disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has a primary diagnosis of major depressive episode according to the Diagnostic and
             Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR)
             criteria.

          -  The reported duration of the current major depressive episode is at least 3 months.

          -  Has a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≥26.

          -  A male or a female of childbearing potential who is sexually active agrees to use
             adequate contraception from Screening throughout the duration of the study and for 1
             month after the last dose of study medication.

        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. (must have negative urine drug screen prior
                  to Baseline).

               -  Presence or history of a clinically significant neurological disorder (including
                  epilepsy).

               -  Neurodegenerative disorder (Alzheimer disease, Parkinson disease, multiple
                  sclerosis, Huntington disease, etc).

          -  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, or has made a suicide attempt in the previous 6 months.

          -  Currently receiving formal cognitive or behavioral therapy, systematic psychotherapy,
             or plans to initiate such therapy during the study.

          -  Has a clinically significant unstable illness.

          -  Has previously failed to respond to adequate treatment with selective serotonin
             reuptake inhibitors and/or serotonin-norepinephrine reuptake inhibitors.

          -  Has received electroconvulsive therapy within 6 months prior to Screening.

          -  Has an alanine aminotransferase, aspartate aminotransferase, or total bilirubin level
             > 1.5 times the upper limit of normal.

          -  Has a serum creatinine of > 1.5 × upper limit of normal.

          -  Has a previous history of cancer that had been in remission for less than 5 years.

          -  Has thyroid stimulating hormone value outside the normal range.

          -  Has an abnormal electrocardiogram.