Efficacy and Safety of Lu AA21004 in Acute Treatment of Major Depressive Disorder

• To evaluate the efficacy of two fixed doses of Lu AA21004 (15 or 20 mg/day) versus placebo as assessed by the change from baseline in MADRS total score after 8 weeks of treatment in adult patients with moderate to severe MDD. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  

• To compare the effect of Lu AA21004 to that of placebo at Week 8 on patients who respond (response defined as a >=50% decrease in the MADRS total score from baseline) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  
• To compare the effect of Lu AA21004 to that of placebo at Week 8 on global improvement as assessed by CGI-I [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  
• To compare the effect of Lu AA21004 to that of placebo at Week 8 on depressive symptoms in patients with a high baseline level of anxiety (defined by HAM-A), as assessed by MADRS total score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  
• To compare the effect of Lu AA21004 to that of placebo at Week 8 on patients who are in remission (remission defined as a MADRS total score <=10) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  
• To compare the effect of Lu AA21004 to that of placebo at Week 8 on disability as assessed by SDS total score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  
• To evaluate the effect of Lu AA21004 on sexual function as assessed by ASEX versus placebo [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  
• To evaluate the safety and tolerability of Lu AA21004 (15 or 20 mg/day) versus placebo during treatment [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  
• To evaluate the potential discontinuation symptoms after abrupt discontinuation of treatment with Lu AA21004 [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
  

Major Depressive Disorder (MDD) is reported to be the most common mood disorder, with a lifetime prevalence of about 15% and as high as 25% in women. MDD is characterised by the presence of one or more Major Depressive Episodes (MDEs) that presents with depressed mood, loss of interest or pleasure, disturbed sleep or appetite, low energy, feelings of guilt or low self-worth, and poor concentration. MDD is a disabling, severe illness that tends to be chronic, and repeated episodes are common. Despite the availability of a range of effective treatments in MDD, a significant proportion of patients do not respond or achieve remission and many relapse despite continued treatment. Lu AA21004 has a novel mechanism of action and this could be of clinical relevance in addressing currently unmet needs in MDD.