NCT01428661

Melatonin Agonist Effects of Tasimelteon Versus Placebo in Patients With Major Depressive Disorder

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 507 (actual)
• Sponsor: Vanda Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	tasimelteon	20 mg once daily
DRUG	placebo	once daily

Timeline

• Start date: 2011-09-01
• Primary completion: 2013-01-01
• Completion: 2013-05-01
• First posted: 2011-09-05
• Last updated: 2015-06-19
• Results posted: 2015-06-19

Locations

40 sites across 1 country: United States