Clinical trial NCT01255787 (phase 2/phase 3, status: completed)
Conditions: depressive disorder, major
ICD codes: F33.0, F33.1, F33.9, F32.0, F32.1, F32.9, F33.40
Drugs: vortioxetine, placebo
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
Eligibility criteria:

        Inclusion Criteria:

          1. Suffers from Major Depressive Disorder as the primary diagnosis according to
             Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision
             (DSM-IV-TR) criteria (classification code 296.2x and 296.3x).

          2. The reported duration of the current major depressive episode is at least 3 months at
             the Screening Visit.

          3. Has a Montgomery-Åsberg Depression Rating Scale (MADRS) total score ≥26 at the
             Screening and Baseline Visits.

          4. Has a Clinical Global Impression Scale-Severity (CGI-S) score ≥4 at the Screening and
             Baseline Visits.

        Exclusion Criteria:

          1. Has one or more of the following conditions:

               -  Any current psychiatric disorder other than Major Depressive Disorder as defined
                  in the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text
                  Revision (DSM-IV-TR; assessed by the Mini International Neuropsychiatric
                  Interview: MINI). A participant who exhibits symptoms of anxiety is eligible
                  unless fulfilling the diagnostic criteria for a current anxiety disorder per
                  DSM-IV-TR.

               -  Current diagnosis or history of manic or hypomanic episode, schizophrenia or any
                  other psychotic disorder, including major depression with psychotic features,
                  mental retardation, organic mental disorders, or mental disorders due to a
                  general medical condition as defined in the DSM-IV-TR.

               -  Current diagnosis or history of any substance-related disorder (except nicotine
                  and caffeine-related disorders) as defined in the DSM-IV-TR. Participant with
                  confirmed positive urine drug screens (except prescribed medications or a
                  medication that does not constitute drug abuse) will be excluded.

               -  Presence or history of a clinically significant neurological disorder (including
                  epilepsy).

               -  Neurodegenerative disorder. (Alzheimer's disease, Parkinson's disease, multiple
                  sclerosis, Huntington's disease, etc.)

               -  Any DSM-IV-TR axis II disorder that might compromise the study.

          2. The current depressive symptoms of the participant are considered by the investigator
             to have been resistant to 2 adequate antidepressant treatments of at least 6 weeks
             duration each.

          3. Has received electroconvulsive, vagal nerve stimulation, or repetitive transcranial
             magnetic stimulation therapy within 6 months prior to the Screening Visit.

          4. Is currently receiving formal cognitive or behavioral therapy, systematic
             psychotherapy, or plans to initiate such therapy during the study.

          5. Is at significant risk of suicide or has a score ≥5 on Item 10 (suicidal thoughts) of
             the MADRS, or has attempted suicide within 6 months prior to the Screening Visit.