Study of Lu AA21004 in Major Depressive Disorder in Asian Countries

• Change in CGI-S score from baseline to Week 8 [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]
  Clinical Global Impression Scale - Severity of Illness (CGI-S) provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients).
• Change in CGI-I score from baseline to Week 8 [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]
  The Clinical Global Impression - Global Improvement (CGI-I) provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). In all cases, the assessment should be made independent of whether the rater believes the improvement is drug-related or not.
• Change in HAM-A total score from baseline to Week 8 [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]
  Hamilton Anxiety Rating Scale (HAM-A) is a 14-item rating scale designed to assess the global anxiety. Each symptom is rated from 0 (absent) to 4 (maximum severity). The total score of the 14 items ranges from 0 to 56.
• MADRS response at Week 8 (response defined as a ≥50% decrease in the MADRS total score from baseline) [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
• Remission at Week 8 (remission defined as a MADRS total score ≤10) [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
• Safety and tolerability of Lu AA21004 [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: Yes ]
  Adverse event monitoring

This study will be conducted with the aim of investigating the efficacy, safety and tolerability of 10 mg/day Lu AA21004 in Asian patients compared to an approved active comparator (venlafaxine extended release 150 mg/day).

• Drug: Lu AA21004
  10 mg/day
  Other Name: Vortioxetine
• Drug: venlafaxine extended release
  150 mg/day
  Other Name: Efexor® XL

• Experimental: Lu AA21004
  Intervention: Drug: Lu AA21004
• Active Comparator: venlafaxine extended release
  Intervention: Drug: venlafaxine extended release

Inclusion Criteria:

• The patient suffers from recurrent MDD as the primary diagnosis according to DSM-IVTR™ criteria. The current Major Depressive Episode (MDE) should be confirmed using the Mini International Neuropsychiatric Interview (MINI)
• The patient has a MADRS total score ≥26
• The patient has a CGI-S score ≥4
• The reported duration of the current MDE is ≥3 months.

Other inclusion criteria may apply.

Exclusion Criteria:

• The patient meets any of the exclusion criteria listed in the protocol or, in the investigator's opinion, is unlikely to comply with the protocol or is unsuitable for any reason.