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 apsychiatric 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 beconfirmed 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 theRAVLT (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 withpsychotic features.

• The patient suffers from personality disorders, mental retardation, pervasivedevelopment disorder, attention-deficit/hyperactivity disorder, organic mentaldisorders, 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 toadversely 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 (suicidalthoughts) of the MADRS, or has attempted suicide <6 months prior to the ScreeningVisit.

• The patient has received electroconvulsive therapy <6 months prior to the ScreeningVisit.

• The current depressive symptoms are considered by the investigator to have beenresistant to 2 adequate antidepressant treatments of at least 6 weeks duration each atthe recommended dose.

• The patient has a history of moderate or severe head trauma (for example, loss ofconsciousness for more than 1 hour) or other neurological disorders or systemicmedical diseases that are, in the opinion of the investigator, likely to affectcentral nervous system functioning.

• The patient has a history of cancer, other than basal cell or Stage 1 squamous cellcarcinoma of the skin, that has not been in remission for >5 years prior to the firstdrug 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 theinvestigator's opinion, clinically significant.

• The patient is, in the investigator's opinion, unlikely to comply with the protocol oris unsuitable for any reason.

• The patient has previously been exposed to Vortioxetine. Other protocol-defined inclusion and exclusion criteria may apply.