Conditions: Major Depressive Disorder
Keywords: tasimelteon Major Depressive Disorder MDD depression
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 507
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: tasimelteon intervention 2: placebo
Intervention descriptions: intervention 1: 20 mg once daily intervention 2: once daily

Protocol document: