Major Depressive Disorder Clinical Trial
Official title:
MAGELLAN: A Multicenter, Randomized, Double-Masked, Placebo-Controlled, Parallel Study to Investigate the Safety and Efficacy of 20 Mg Tasimelteon Versus Placebo in Adult Subjects With Major Depressive Disorder Followed by a 52-Week Open-Label Extension
The purpose of this study is to evaluate the safety and efficacy of an 8-week double-masked treatment of tasimelteon or placebo in male and female subjects with Major Depressive Disorder.
This is a randomized, parallel, double-masked, placebo-controlled, multicenter outpatient
study comparing tasimelteon with placebo in the treatment of subjects with Major Depressive
Disorder (MDD).
The study has three phases: the pre-randomization phase, the randomization phase, and an
open-label extension phase. The pre-randomization phase comprises a screening visit where
subject's initial eligibility will be evaluated. The randomization phase is comprised of an
8-week double-masked segment. Subjects meeting all entry criteria for the study will enter
the randomization phase. During this phase, subjects will be asked to take either 20 mg
tasimelteon or placebo for 8 weeks in a double-masked fashion. At the end of the 8-week
double-masked phase, those subjects who completed the 8-week treatment phase will be offered
to enroll into a 52-week open-label extension where each subject will receive daily doses of
20 mg tasimelteon.
;
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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