Clinical trial NCT02272517 (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 10-20 mg, escitalopram 10-20 mg
SMILES: CC1=CC=C(SC2=CC=CC=C2N2CCNCC2)C(C)=C1, CN(C)CCCC1(OCC2=C1C=CC(=C2)C#N)C1=CC=C(F)C=C1
Eligibility criteria:

        Inclusion Criteria:

          -  The patient has MDD, diagnosed according to DSM-IV-TR™ recurrent MDE (classification
             296.3x) as confirmed using the Mini International Neuropsychiatric Interview (MINI).

          -  The patient has depressive symptoms currently considered as non- or only partially
             responsive (inadequate response), to one adequate course of SSRI/SNRI antidepressant
             monotherapy and is candidate for a switch in the investigator's opinion.

          -  The patient wants to stop taking his/her current SSRI/SNRI treatment due to inadequate
             response confirmed by the Antidepressant Treatment Response Questionnaire (ATRQ), <50%
             response to current treatment).

          -  The patient must have been treated by SSRI/SNRI monotherapy (citalopram, paroxetine,
             sertraline, duloxetine, or venlafaxine) for at least 6 weeks at licensed doses prior
             to the Screening Visit.

          -  The patient has a PHQ-9 total score ≥14.

          -  The patient has a MADRS total score ≥ 22.

          -  The patient has had the current MDE for ≤1 year.

          -  The patient has a Perceived Deficits Questionnaire - Depression (PDQ-D) total score
             >25.

          -  The patient is a man or woman aged ≥18 and ≤65 years.

        Exclusion Criteria:

          -  The patient has a score ≥70 on the DSST (Number of Correct Symbols) 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 has any current psychiatric disorder or Axis I disorder (according to
             DSMIV-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, histrionic, antisocial
             personality disorders (axis II) as comorbid or primary diagnosis (DSM-IV-TR™
             criteria).

          -  The patient has history of previous MDEs considered as treatment resistant defined as
             inadequate response (incomplete or no therapeutic response) to two prior courses of at
             least 6 weeks of conventional antidepressant drugs in adequate dosages or, the patient
             has treatment-resistant depression in the investigator's judgement.

          -  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 diagnosis of alcohol or other substance abuse or dependence
             (excluding nicotine or caffeine) (DSM-IV-TR™ criteria) that has not been in sustained
             full remission at least 2 years prior to the Screening Visit.

          -  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.