Efficacy and Safety Study of Lu AA21004 in Adults With Major Depressive Disorder

Depression has been recognized as a chronic illness that imposes a significant burden on
individuals, families and society. Major depressive disorder (MDD) 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.

This study will involve approximately 450 participants from approximately 35 sites in North
America.