Safety and Efficacy of Vortioxetine (Lu AA21004) in Adults With Major Depressive Disorder
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Vortioxetine; Duloxetine; Placebo
Intervention description: Encapsulated vortioxetine immediate release tablets; Overencapsulated duloxetine delayed-release 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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 614.0
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, safety and tolerability of
      vortioxetine, once daily (QD), compared with placebo in adults with major depressive
      disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Man or a woman who 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 (classification code
             296.3x) as confirmed by the Structured Clinical Interview for DSM Disorders (SCID).

          2. The reported duration of the current MDE is at least 3 months.

          3. Has a Montgomery Åsberg Depression Rating Scale (MADRS) total score of 26 or greater
             at Screening and Baseline Visits.

          4. Has a Clinical Global Impression - Severity of Illness (CGI-S) score of 4 or greater
             at Screening and Baseline Visits.

        Exclusion Criteria:

          1. Has previously participated in a Lu AA21004 clinical study.

          2. Has 1 or more the following:

               1. Any current psychiatric disorder other than major depressive disorder (MDD) as
                  defined in the DSM-IV-TR (as assessed by the SCID).

               2. 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.

               3. Diagnosis of any substance abuse or dependence (except nicotine and caffeine) as
                  defined in the DSM-IV-TR that has not been in sustained full remission for at
                  least 2 years prior to screening (subject must also have negative urine drug
                  screen prior to Baseline).

               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.

          3. 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 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.

          4. Has a thyroid stimulating hormone value outside the normal range at the Screening
             Visit that is deemed clinically significant by the investigator.

          5. Has clinically significant abnormal vital signs as determined by the investigator.

          6. Has an abnormal electrocardiogram as determined by the central reader and confirmed as
             clinically significant by the investigator.

          7. Has an alanine aminotransferase, aspartate aminotransferase or total bilirubin level
             greater than 1.5 times the upper limits of normal.

          8. 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 those
             patients with basal cell or Stage I squamous cell carcinoma of the skin.

          9. Has a disease or takes medication that, in the opinion of the investigator, could
             interfere with the assessments of safety, tolerability, or efficacy.

         10. Has a known history of or currently has increased intraocular pressure or is at risk
             of acute narrow-angle glaucoma.

         11. 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. The following are also considered unstable due to
             the potential impact on assessment of MDD response: pain disorder, chronic fatigue
             syndrome, fibromyalgia, and obstructive sleep apnea.

         12. 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.