Clinical trial NCT01422213 (phase 3, status: completed)
Conditions: major depressive disorder
ICD codes: F33.0, F33.1, F33.9, F32.0, F32.1, F32.9, F33.40
Drugs: placebo, vortioxetine (lu aa21004), vortioxetine (lu aa21004)
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, CC1=CC=C(SC2=CC=CC=C2N2CCNCC2)C(C)=C1, CC1=CC=C(SC2=CC=CC=C2N2CCNCC2)C(C)=C1
Eligibility criteria:

        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 <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 Vortioxetine.

        Other protocol-defined inclusion and exclusion criteria may apply.