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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vanda Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01428661
First received: August 31, 2011
Last updated: February 3, 2014
Last verified: February 2014
  Purpose

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 Intervention Phase
Major Depressive Disorder
Drug: tasimelteon
Drug: placebo
Phase 2
Phase 3

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Vanda Pharmaceuticals:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 507
Study Start Date: September 2011
Study Completion Date: May 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: tasimelteon Drug: tasimelteon
20 mg once daily
Placebo Comparator: placebo Drug: placebo
once daily

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01428661

  Hide Study Locations
Locations
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
  More Information

No publications provided

Responsible Party: Vanda Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01428661     History of Changes
Other Study ID Numbers: VP-VEC-162-2301
Study First Received: August 31, 2011
Last Updated: February 3, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Vanda Pharmaceuticals:
tasimelteon
Major Depressive Disorder
MDD
depression

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on August 28, 2014