Safety and Tolerability of Lu AA21004 in Subjects With Major Depressive Disorder

• Physical Examination [ Time Frame: Weeks 4, 12, 24, 36 and Final Visit ] [ Designated as safety issue: Yes ]
  
• Clinical Laboratory Data (chemistry, hematology and urinalysis) [ Time Frame: Weeks 4, 8, 12, 20, 28, 36, 44 and Final Visit ] [ Designated as safety issue: Yes ]
  
• Electrocardiogram [ Time Frame: Weeks 4, 12, 24, 36 and Final Visit ] [ Designated as safety issue: Yes ]
  
• Adverse Events [ Time Frame: At All Visits ] [ Designated as safety issue: Yes ]
  
• Vital Signs and Body Weight [ Time Frame: At All Visits ] [ Designated as safety issue: Yes ]
  

• Mean change from Baseline in Hamilton Depression Scale-24 Item total score. [ Time Frame: At All Visits ] [ Designated as safety issue: No ]
  
• Medical Outcomes Study 36-item Short Form, each of the 8 subscales separately. [ Time Frame: Weeks: 24 and Final Visit ] [ Designated as safety issue: No ]
  
• Sheehan Disability Scale [ Time Frame: Weeks: 24 and Final Visit ] [ Designated as safety issue: No ]
  
• Health Economic Assessment Questionnaire [ Time Frame: Weeks: 24 and Final Visit ] [ Designated as safety issue: No ]
  
• Mean change from Baseline in the Montgomery Åsberg Depression Rating Scale total score [ Time Frame: Weeks 4, 24 and Final Visit ] [ Designated as safety issue: No ]
  
• Mean change from Baseline in the Hamilton Anxiety Scale total score [ Time Frame: Weeks 4, 24 and Final Visit ] [ Designated as safety issue: No ]
  
• Mean change from Baseline in the Clinical Global Impression of Severity of Illness scale. [ Time Frame: Weeks 4, 24 and Final Visit ] [ Designated as safety issue: No ]
  

Depression has been recognized as a chronic illness that imposes a significant burden on individuals, families and society. Major depressive disorder is among the most important causes of disability worldwide, in both developing and developed countries. Major depressive disorder is reported to be the most common mood disorder, with a lifetime prevalence of about 15% and as high as 25% in women. Major depressive disorder is characterized by the presence of 1 or more major depressive episodes 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. Studies suggest that at least 70% of depressed patients also report somatic symptoms such as pain, shortness of breath, fatigue, or nausea. A number of patients may present with somatic symptoms as the main complaint rather than depressed mood. Depression is recurrent in 75% to 80% of patients, becomes chronic (ie, lasting 2 years or longer) in 15% to 20% of depressed patients, and can lead to substantial impairments in an individual's ability to take care of his or her everyday responsibilities. Furthermore, depression may lead to suicide and the mortality due to suicide is approximately 15% among patients treated by psychiatrists. Major depressive disorder imposes a socioeconomic burden comparable to chronic medical illnesses in terms of healthcare utilization, decreased productivity, and dysfunctional family life, and is associated with an increased consumption of general medical, psychiatric and emergency services.

Lu AA21004 is a compound under development by Takeda Pharmaceutical Company Limited and H. Lundbeck A/S with clinical development for the treatment of major depressive disorder.