Efficacy Study of Vortioxetine (Lu AA21004) for Treatment of Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Vortioxetine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Vortioxetine tablets; Vortioxetine placebo
Other intervention name(s): Lu AA21004; BRINTELLIX; Vortioxetine placebo-matching tablets
Intervention MeSH terms: Vortioxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Drug Therapy