Long-Term Extension Study of Lu AA21004 in Participants With 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 safety and efficacy of Lu AA21004 in participants
      with major depressive disorder after completion of an 8-week double-blind treatment period in
      a preceding study (Lu AA21004/CCT-003; NCT01355081).
    

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 long-term extension study will assess the safety and efficacy of 52-week treatment with
      Lu AA21004 in participants with major depressive disorder after completion of the 8-week
      double-blind treatment period in the preceding study (LuAA21004/CCT-003; NCT01355081;
      hereinafter referred to as CCT-003). This study will be conducted at the same institutions as
      CCT-003.

      This study will include participants who completed the 8-week double-blind treatment period
      in CCT-003, and who meet all of the inclusion criteria, and do not meet any of the exclusion
      criteria of the long-term study. Visit 1 in this study will be the last visit (Visit 7)
      during the 8-week double-blind treatment period in CCT-003. Participants will start 2-week
      treatment with 10 mg/day of Lu AA21004 on the day after completion of the 8-week double-blind
      treatment period in CCT-003. The dose may then be decreased to 5 mg/day or increased to 20
      mg/day according to the responses and symptoms of the participants. A dose increase, however,
      will be allowed only if the Clinical Global Impression (CGI) score meets the criteria for
      dose increases and the investigator or sub-investigator considers it necessary to increase
      the dose. The same dose should be maintained for at least 2 weeks after a dose change, except
      when immediate dose reduction is required for safety reasons. Neither dose increase from 5 to
      20 mg nor dose reduction from 20 to 5 mg will be allowed.

      The duration of administration will be 52 weeks. Participants will visit the study site every
      2 weeks during the first month of treatment and every 4 weeks thereafter (Weeks 2, 4, 8, 12,
      16, 20, 24, 28, 32, 36, 40, 44, 48, and 52). Participants will be followed up 4 weeks after
      the last dose of the study drug, and those who prematurely discontinue the study will also be
      followed up 4 weeks after the last dose, whenever possible.
    

Intervention name(s): Lu AA21004
Intervention type(s): Drug
Intervention description(s): Lu AA21004 10 mg, tablets, orally, once daily for 2 weeks; reduced to 5 mg or increased to 20 mg, once daily if necessary according to the responses and symptoms of participants for up to 50 weeks.
Intervention MeSH terms: Vortioxetine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Drug Therapy