Major Depressive Disorder Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase III Study to Assess the Efficacy and Safety of Lu AA21004 in Patients With Major Depressive Disorder
The purpose of this study is to assess the efficacy, safety and tolerability of 8-week
treatment with Vortioxetine (Lu AA21004), once daily (QD), in Japanese participants with
major depressive disorder.
The purpose of this study is to assess the efficacy, safety and tolerability of 8-week
treatment with Lu AA21004, once daily (QD), in Japanese participants with major depressive
disorder.
Lu AA21004 was discovered by H. Lundbeck A/S, and is under co-development by H. Lundbeck A/S
and Takeda for the treatment of major depressive disorder and general anxiety disorder.
Major depressive disorder (MDD) is a chronic, recurring disease with considerable morbidity
in the general population. The estimated lifetime prevalence of major depression in the
adult population is 5 to 25%, with approximately 2-fold higher prevalence in women than in
men. The hallmark of the disease is a depressed mood, with additional symptoms including
sleep disturbances, psychomotor agitation or retardation, sexual dysfunction, weight loss,
concentration difficulties and delusional ideas. In addition to direct ill effects, MDD
causes suicide or job loss and exerts indirect influence on social economy. This study will
assess the efficacy and the safety of Lu AA21004. This study consists of a 1-week screening
period, an 8-week double-blind treatment period, 4-week safety follow-up.The duration of the
study is 13 weeks in total. Blood samples will be collected from participants, and a safety
follow-up contact (visit or phone call) will be made 4 weeks after completion of the 8-week
double-blind treatment period. Subjects who complete the 8-week double-blind treatment
period can successively enter a long-term extension study (Lu AA21004/OCT-001; NCT01395147;
hereinafter, OCT-001), if they meet all inclusion criteria and none of exclusion criteria of
the OCT-001 study and are willing to participate in the OCT-001 study. Subjects who will
enter the OCT-001 will not be requested to safety follow-up after completion of the 8-week
double-blind treatment period.
Lu AA21004 was discovered by H. Lundbeck A/S, and is under co-development by H. Lundbeck A/S
and Takeda for the treatment of major depressive disorder and general anxiety disorder.
Major depressive disorder (MDD) is a chronic, recurring disease with considerable morbidity
in the general population. The estimated lifetime prevalence of major depression in the
adult population is 5 to 25%, with approximately 2-fold higher prevalence in women than in
men. The hallmark of the disease is a depressed mood, with additional symptoms including
sleep disturbances, psychomotor agitation or retardation, sexual dysfunction, weight loss,
concentration difficulties and delusional ideas. In addition to direct ill effects, MDD
causes suicide or job loss and exerts indirect influence on social economy.
This study will assess the efficacy and the safety of Lu AA21004. This study consists of a
1-week screening period, an 8-week double-blind treatment period, 4-week s safety
follow-up.The duration of the study is 13 weeks in total. Blood samples will be collected
from participants, and a safety follow-up contact (visit or phone call) will be made 4 weeks
after completion of the 8-week double-blind treatment period.
Subjects who complete the 8-week double-blind treatment period can successively enter a
long-term extension study (Lu AA21004/OCT-001; NCT01395147; hereinafter, OCT-001), if they
meet all inclusion criteria and none of exclusion criteria of the OCT-001 study and are
willing to participate in the OCT-001 study.
Subjects who will enter the OCT-001 will not be requested to safety follow-up after
completion of the 8-week double-blind treatment period.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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