Melatonin Agonist Effects of Tasimelteon Versus Placebo in Patients With Major Depressive Disorder (MAGELLAN)
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.
Major Depressive Disorder
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|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|
- Change from Baseline to endpoint at Week 8 using the total score of the Hamilton Depression Rating Scale (HAM-D) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Compare the safety and tolerability of tasimelteon to placebo [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
- To assess the number of participants with changes in clinical laboratory and ECG data.
- Recording of adverse events and vital signs.
- Compare the efficacy of tasimelteon to placebo on circadian rhythms and sleep parameters [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Compare the impact of treatment with tasimelteon to placebo on sexual functioning and quality of life [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]-As measured by the Arizona Sexual Experience Scale (ASEX) and Sheehan Disability Scale (SDS).
- Assess suicidality in subjects taking tasimelteon or placebo [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]-Measured using the Columbia-Suicide Severity Rating Scale (C-SSRS).
- Explore the contribution of genetic factors on efficacy and safety outcomes [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
- To evaluate the efficacy of tasimelteon compared to placebo using MADRS, CGI-S and HAM-A [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||September 2011|
|Estimated Study Completion Date:||December 2013|
|Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
20 mg once daily
|Placebo Comparator: placebo||
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.
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