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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01428661
Recruitment Status : Completed
First Posted : September 5, 2011
Results First Posted : June 19, 2015
Last Update Posted : June 19, 2015
Information provided by (Responsible Party):
Vanda Pharmaceuticals

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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: tasimelteon Drug: placebo Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 507 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : September 2011
Actual Primary Completion Date : January 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Tasimelteon

Arm Intervention/treatment
Experimental: tasimelteon Drug: tasimelteon
20 mg once daily

Placebo Comparator: placebo Drug: placebo
once daily

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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;
  • Participation in a previous tasimelteon trial. Other protocol-defined inclusion/exclusion criteria may apply

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01428661

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United States, California
Vanda Investigational Site
Garden Grove, California, United States, 92845
Vanda Investigational Site
Irvine, California, United States, 92617
Vanda Investigational Site
Los Alamitos, California, United States, 90720
Vanda Investigational Site
Oakland, California, United States, 94612
Vanda Investigational Site
Oceanside, California, United States, 92056
Vanda Investigational Site
San Diego, California, United States, 92102
Vanda Investigational Site
Sherman Oaks, California, United States, 91403
Vanda Investigational Site
Torrance, California, United States, 90502
United States, Colorado
Vanda Investigational Site
Denver, Colorado, United States, 80239
United States, Florida
Vanda Investigational Site
Bradenton, Florida, United States, 34201
Vanda Investigational Site
Jacksonville, Florida, United States, 32216
Vanda Investigational Site
Maitland, Florida, United States, 32751
Vanda Investigational Site
N. Miami, Florida, United States, 33161
Vanda Investigational Site
Orlando, Florida, United States, 32806
United States, Georgia
Vanda Investigational Site
Atlanta, Georgia, United States, 30308
Vanda Investigational Site
Atlanta, Georgia, United States, 30328
United States, Illinois
Vanda Investigational Site
Chicago, Illinois, United States, 60640
Vanda Investigational Site
Joliet, Illinois, United States, 60435
United States, Kansas
Vanda Investigational Site
Prairie Village, Kansas, United States, 66205
United States, Maryland
Vanda Investigational Site
Baltimore, Maryland, United States, 21208
United States, Massachusetts
Vanda Investigational Site
Boston, Massachusetts, United States, 02135
United States, Nebraska
Vanda Investigational Site
Omaha, Nebraska, United States, 68198
United States, Nevada
Vanda Investigational Site
Las Vegas, Nevada, United States, 89102
United States, New Jersey
Vanda Investigational Site
Toms River, New Jersey, United States, 08755
Vanda Investigational Site
Willingboro, New Jersey, United States, 08046
United States, New York
Vanda Investigational Site
Brooklyn, New York, United States, 11235
Vanda Investigational Site
Mt. Kisco, New York, United States, 10549
Vanda Investigational Site
New York, New York, United States, 10168
Vanda Investigational Site
Rochester, New York, United States, 14618
Vanda Investigational Site
Staten Island, New York, United States, 10312
United States, Ohio
Vanda Investigational Site
Cincinnati, Ohio, United States, 45267
Vanda Investigational Site
Dayton, Ohio, United States, 45417
United States, Oregon
Vanda Investigational Site
Portland, Oregon, United States, 97210
United States, Rhode Island
Vanda Investigational Site
Lincoln, Rhode Island, United States, 02865
United States, Tennessee
Vanda Investigational Site
Memphis, Tennessee, United States, 38119
United States, Texas
Vanda Investigational Site
Austin, Texas, United States, 78731
Vanda Investigational Site
Dallas, Texas, United States, 75231
United States, Utah
Vanda Investigational Site
Salt Lake City, Utah, United States, 84106
United States, Washington
Vanda Investigational Site
Seattle, Washington, United States, 98104
United States, Wisconsin
Vanda Investigational Site
Brown Deer, Wisconsin, United States, 53223
Sponsors and Collaborators
Vanda Pharmaceuticals
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Responsible Party: Vanda Pharmaceuticals Identifier: NCT01428661    
Other Study ID Numbers: VP-VEC-162-2301
First Posted: September 5, 2011    Key Record Dates
Results First Posted: June 19, 2015
Last Update Posted: June 19, 2015
Last Verified: June 2015
Keywords provided by Vanda Pharmaceuticals:
Major Depressive Disorder
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms