Efficacy and Safety of Vortioxetine (Lu AA21004) in Treating Adults With Major Depressive Disorder

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.