Efficacy Study of Vortioxetine on Cognitive Dysfunction in Adult Patients With Major Depressive Disorder

Inclusion Criteria

• The patient is an inpatient in a psychiatric hospital or an outpatient at a psychiatric setting at the time of the study entry.
• The patient is diagnosed with recurrent MDD according to DSM-IV-TR™ criteria (classification code 296.3x). The current Major Depressive Episode (MDE) should be confirmed using the Mini International Neuropsychiatric Interview (MINI).
• The patient has received prescribed treatment for a previous episode of depression.
• The patient has a MADRS total score ≥26.
• The reported duration of the current MDE is at least 3 months.

Exclusion Criteria

• The patient has a score ≥70 on the DSST (number of correct symbols), or ≥42 on the RAVLT (learning) or ≥14 on the RAVLT (memory) at the Baseline Visit.
• The patient has any current Axis I disorder (DSM-IV-TR™ criteria) other than MDD, confirmed using the MINI.
• The patient has a current diagnosis or history of manic or hypomanic episode, schizophrenia or any other psychotic disorder, including major depression with psychotic features.
• The patient suffers from personality disorders, mental retardation, pervasive development disorder, attention-deficit/hyperactivity disorder, organic mental disorders, or mental disorders due to a general medical condition (DSM-IV-TR™ criteria).
• The patient has physical, cognitive, or language impairment of such severity as to adversely affect the validity of the data derived from the neuropsychological tests.
• The patient is diagnosed with reading disability (dyslexia).
• The patient is at significant risk of suicide or has a score ≥5 on Item 10 (suicidal thoughts) of the MADRS, or has attempted suicide 5 years prior to the first drug dose.
• The patient has a clinically significant unstable illness, for example:
• cardiovascular disease
• seizure disorder or encephalopathy
• congestive heart failure
• cardiac hypertrophy
• arrhythmia
• bradycardia (pulse <50 bpm)
• respiratory disease
• hepatic impairment or renal insufficiency
• metabolic disorder
• endocrinological disorder
• gastrointestinal disorder
• haematological disorder
• infectious disorder
• any clinically significant immunological condition
• dermatological disorder
• venereal disease
• The patient has, at the Screening Visit, an abnormal ECG that is, in the investigator's opinion, clinically significant.
• The patient is, in the investigator's opinion, unlikely to comply with the protocol or is unsuitable for any reason.
• The patient has previously been exposed to Vortioxetine.

Other protocol-defined inclusion and exclusion criteria may apply.