Major Depressive Disorder Clinical Trial
Official title:
An Open-label, Long-Term Extension Study to Assess the Safety and Efficacy of Lu AA21004 in Patients With Major Depressive Disorder (Extension to Lu AA21004/CCT-003 Study)
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).
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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