Clinical trial NCT02279966 (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: vortioxetine 10 mg, paroxetine 20 mg, placebo
SMILES: CC1=CC=C(SC2=CC=CC=C2N2CCNCC2)C(C)=C1, FC1=CC=C(C=C1)[C@@H]1CCNC[C@H]1COC1=CC2=C(OCO2)C=C1, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          -  The patient has MDD, diagnosed according to Diagnostic and Statistical Manual of
             Mental Disorders, 4th edition, Text Revision (DSM-IV-TR™) recurrent major depressive
             disorder (MDD) (classification 296.3x).

          -  The patient has a MADRS total score ≥26.

          -  The patient has had the current major depressive episode (MDE) for ≥3 months.

          -  The patient is aged ≥18 and ≤65 years.

          -  The patient is employed full or part-time (defined as minimum 50% full time working
             hours per week). Part time work should not be due to a medical or mental illness other
             than MDD.

          -  The patient has been in the current job/position for at least 3 months.

          -  The patient has no plans to change jobs or retire within treatment period.

          -  The patient is not on a sick leave, and at the Screening and Randomisation Visits,
             there are no plans to send the patient on a sick leave.

          -  The patient is not receiving disability benefits.

        Exclusion criteria:

          -  The patient has a score ≥70 on the DSST (number of correct symbols) at the Baseline
             Visit.

          -  The patient is, in the opinion of the investigator, not able to complete the
             neuropsychological tests validly at the Baseline Visit.

          -  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 has a history of lack of response to previous adequate treatment with
             vortioxetine or paroxetine.

          -  The patient has any current psychiatric disorder or Axis I disorder (according to
             DSM-IV-TR™ criteria) other than MDD, as assessed using MINI.

          -  The patient has a current or has had a diagnosis of dysthymic disorder within 3 months
             preceding the onset of current episode (DSM-IV-TR™ criteria).

          -  The patient has borderline, schizotypal, schizoid, paranoid, or histrionic, antisocial
             personality disorders (axis II) as comorbid or primary diagnosis (DSM-IV-TR™
             criteria).

          -  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 a current diagnosis or history of manic or hypomanic episode,
             schizophrenia or any other psychotic disorder, including major depression with
             psychotic features (DSM-IV-TR™ criteria).

        Other protocol-defined inclusion and exclusion criteria may apply.