Melatonin Agonist Effects of Tasimelteon Versus Placebo in Patients With Major Depressive Disorder (MAGELLAN)
|ClinicalTrials.gov Identifier: NCT01428661|
Recruitment Status : Completed
First Posted : September 5, 2011
Results First Posted : June 19, 2015
Last Update Posted : June 19, 2015
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder||Drug: tasimelteon Drug: placebo||Phase 2 Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||507 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||May 2013|
20 mg once daily
|Placebo Comparator: placebo||
- Change From Baseline to Endpoint at Week 8 Using the Total Score of the Hamilton Depression Rating Scale (HAM-D) [ Time Frame: 8 weeks ]Hamilton Rating Scale for Depression (HAM-D) assesses the range of symptoms that are most frequently observed in subjects with major depressive disorder (MDD) on a scale from 0 to 52. Higher HAM-D scores indicate more severe levels of depressive symptoms, thus, a negative change from baseline indicates a reduction (or improvement) in depressive symptoms.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01428661
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