Clinical trial NCT02279953 (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, placebo, ssri
SMILES: CC1=CC=C(SC2=CC=CC=C2N2CCNCC2)C(C)=C1, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, CNCCC(OC1=CC=C(C=C1)C(F)(F)F)C1=CC=CC=C1
Eligibility criteria:

        Inclusion Criteria:

          -  The patient has achieved either partial (some symptoms of a MDE are present but full
             criteria are not met) or full remission of major depressive disorder (MDD), diagnosed
             according to DSM-IV-TR™.

          -  The patient has HAMD-17 total score ≤10.

          -  The patient has received SSRI monotherapy for the MDE from which the patient is
             currently in full or partial remission for ≥12 weeks at licensed doses and been on
             stable dose ≥8 weeks prior to Screening Visit.

          -  The patient has ≥50% response to current SSRI treatment (Antidepressant Treatment
             Response Questionnaire [ATRQ]).

          -  The patient has a 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 (numbers 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.

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

          -  The patient has a current or has had a diagnosis of dysthymic disorder within 3 months
             preceding the onset of the depressive episode from which the patient is currently in
             full or partial remission (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 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.