Melatonin Agonist Effects of Tasimelteon Versus Placebo in Patients With Major Depressive Disorder
MAGELLAN
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
1 other identifier
interventional
507
1 country
40
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 major-depressive-disorder
Started Sep 2011
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 31, 2011
CompletedStudy Start
First participant enrolled
September 1, 2011
CompletedFirst Posted
Study publicly available on registry
September 5, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedResults Posted
Study results publicly available
June 19, 2015
CompletedJune 19, 2015
June 1, 2015
1.3 years
August 31, 2011
January 6, 2015
June 1, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline to Endpoint at Week 8 Using the Total Score of the Hamilton Depression Rating Scale (HAM-D)
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.
8 weeks
Study Arms (2)
tasimelteon
EXPERIMENTALplacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Subjects with diagnosis of MDD, single or recurrent episode, according to DSM-IV TR criteria;
- Current episode ≥4 weeks and ≤1 year;
- CGI-Severity score ≥4 at screening and baseline.
You may not qualify if:
- Lifetime history of bipolar disorder (I or II), schizophrenia, schizoaffective disorder, eating disorder, or obsessive-compulsive disorder;
- Any other current Axis I (except general anxiety disorder as long as it is not considered the primary disorder) or Axis II disorder;
- A positive test for drugs of abuse at the screening visit and/or history of drug or alcohol abuse/dependence as defined in DSM-IV TR, Diagnostic Criteria for Drug and Alcohol Abuse and Dependence, within the past 12 months;
- Formal psychotherapy within 3 months of the screening visit. General supportive psychotherapy is acceptable;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (40)
Vanda Investigational Site
Garden Grove, California, 92845, United States
Vanda Investigational Site
Irvine, California, 92617, United States
Vanda Investigational Site
Los Alamitos, California, 90720, United States
Vanda Investigational Site
Oakland, California, 94612, United States
Vanda Investigational Site
Oceanside, California, 92056, United States
Vanda Investigational Site
San Diego, California, 92102, United States
Vanda Investigational Site
Sherman Oaks, California, 91403, United States
Vanda Investigational Site
Torrance, California, 90502, United States
Vanda Investigational Site
Denver, Colorado, 80239, United States
Vanda Investigational Site
Bradenton, Florida, 34201, United States
Vanda Investigational Site
Jacksonville, Florida, 32216, United States
Vanda Investigational Site
Maitland, Florida, 32751, United States
Vanda Investigational Site
North Miami, Florida, 33161, United States
Vanda Investigational Site
Orlando, Florida, 32806, United States
Vanda Investigational Site
Atlanta, Georgia, 30308, United States
Vanda Investigational Site
Atlanta, Georgia, 30328, United States
Vanda Investigational Site
Chicago, Illinois, 60640, United States
Vanda Investigational Site
Joliet, Illinois, 60435, United States
Vanda Investigational Site
Prairie Village, Kansas, 66205, United States
Vanda Investigational Site
Baltimore, Maryland, 21208, United States
Vanda Investigational Site
Boston, Massachusetts, 02135, United States
Vanda Investigational Site
Omaha, Nebraska, 68198, United States
Vanda Investigational Site
Las Vegas, Nevada, 89102, United States
Vanda Investigational Site
Toms River, New Jersey, 08755, United States
Vanda Investigational Site
Willingboro, New Jersey, 08046, United States
Vanda Investigational Site
Brooklyn, New York, 11235, United States
Vanda Investigational Site
Mount Kisco, New York, 10549, United States
Vanda Investigational Site
New York, New York, 10168, United States
Vanda Investigational Site
Rochester, New York, 14618, United States
Vanda Investigational Site
Staten Island, New York, 10312, United States
Vanda Investigational Site
Cincinnati, Ohio, 45267, United States
Vanda Investigational Site
Dayton, Ohio, 45417, United States
Vanda Investigational Site
Portland, Oregon, 97210, United States
Vanda Investigational Site
Lincoln, Rhode Island, 02865, United States
Vanda Investigational Site
Memphis, Tennessee, 38119, United States
Vanda Investigational Site
Austin, Texas, 78731, United States
Vanda Investigational Site
Dallas, Texas, 75231, United States
Vanda Investigational Site
Salt Lake City, Utah, 84106, United States
Vanda Investigational Site
Seattle, Washington, 98104, United States
Vanda Investigational Site
Brown Deer, Wisconsin, 53223, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Curt Wolfgang, Ph.D.
- Organization
- Vanda Pharmaceuticals Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 31, 2011
First Posted
September 5, 2011
Study Start
September 1, 2011
Primary Completion
January 1, 2013
Study Completion
May 1, 2013
Last Updated
June 19, 2015
Results First Posted
June 19, 2015
Record last verified: 2015-06