Efficacy Study of Lu AA21004 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 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 (numbers correct), ≥42 on the RAVLT
(learning) and ≥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 <6 months prior to the Screening
Visit.

- The patient has received electroconvulsive therapy <6 months prior to the Screening
Visit.

- 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
at the recommended dose.

- The patient has a history of moderate or severe head trauma (for example, loss of
consciousness for more than 1 hour) or other neurological disorders or systemic
medical diseases that are, in the opinion of the investigator, likely to affect
central nervous system functioning.

- The patient has a history of cancer, other than basal cell or Stage 1 squamous cell
carcinoma of the skin, that has not been in remission for >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 Lu AA21004.

Other inclusion and exclusion criteria may apply.