Efficacy and Safety of Vortioxetine (Lu AA21004) in Treating 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 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: 600.0
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 once daily vortioxetine
      (Lu AA21004) in adults with major depressive disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Suffers from a major depressive episode (MDE) 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 MDE is at least 3 months.

          -  Has a Montgomery Åsberg Depression Rating Scale total score greater than or equal to
             30.

          -  Females of childbearing potential who are sexually active must agree to use adequate
             contraception, and can neither be pregnant nor lactating from Screening throughout the
             duration of the study.

        Exclusion Criteria:

          -  Has received any investigational compound less than 30 days before Screening or 5
             half-lives prior to Screening, whichever is longer.

          -  Has received Lu AA21004 in a previous clinical study.

          -  Has 1 or more the following:

               -  Any current psychiatric disorder other than major depressive disorder as defined
                  in the DSM-IV-TR (as assessed by the Mini International Neuropsychiatric
                  Interview)

               -  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.

          -  Is required to take or intends to continue taking any disallowed medication, any
             prescription medication, herbal treatment or over-the counter medication that may
             interfere with evaluation of the study medication, including:

               -  Narcotic analgesics

               -  Nonsteroidal anti-inflammatory drugs

               -  Rifampin

               -  Macrolide antibiotics

               -  Hormones (only thyroid hormone replacement, contraceptives [oral, patch],
                  estrogen and progesterone replacement therapy are allowed in chronic use)

               -  Hypoglycemic agents (chronic use is allowed)

               -  Insulin (chronic use is allowed)

               -  Systemic steroids

               -  Quinidine

               -  Antineoplastics

               -  Antiobesity agents

          -  Has a significant risk of suicide according to the investigator's opinion or has a
             score greater than or equal to 5 on item 10 (suicidal thoughts) of the Montgomery
             Åsberg Depression Rating Scale or has made a suicide attempt in the previous 6 months.

          -  The current depressive symptoms 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.

          -  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.

          -  Has an alanine aminotransferase, aspartate aminotransferase or total bilirubin level
             greater than 1.5 times the upper limits of normal.

          -  Has a serum creatinine 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. This criterion does not include basal
             cell or Stage I squamous cell carcinoma of the skin.

          -  Has clinically significant abnormal vital signs as determined by the investigator.

          -  Has an abnormal electrocardiogram determined by the central reader and confirmed as
             clinically significant by the investigator.

          -  Has 1 or more laboratory values outside the normal range, based on the blood or urine
             samples taken at the Screening Visit, that are considered by the investigator to be
             clinically significant.

          -  Has a thyroid stimulating hormone value outside the normal range at Screening Visit
             that is determined to be clinically significant by the investigator.

          -  Has a disease or takes medication that, in the opinion of the investigator, could
             interfere with the assessments of safety, tolerability, or efficacy.

          -  Has previously enrolled in this study.