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

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.

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Drug: tasimelteon; Drug: placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 507
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • 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
      • Vanda Investigational Site
  • Colorado
    • Denver, Colorado, United States, 80239
      • Vanda Investigational Site
  • Florida
    • 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
      • Vanda Investigational Site
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Vanda Investigational Site
    • Atlanta, Georgia, United States, 30328
      • Vanda Investigational Site
  • Illinois
    • Chicago, Illinois, United States, 60640
      • Vanda Investigational Site
    • Joliet, Illinois, United States, 60435
      • Vanda Investigational Site
  • Kansas
    • Prairie Village, Kansas, United States, 66205
      • Vanda Investigational Site
  • Maryland
    • Baltimore, Maryland, United States, 21208
      • Vanda Investigational Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02135
      • Vanda Investigational Site
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • Vanda Investigational Site
  • Nevada
    • Las Vegas, Nevada, United States, 89102
      • Vanda Investigational Site
  • New Jersey
    • Toms River, New Jersey, United States, 08755
      • Vanda Investigational Site
    • Willingboro, New Jersey, United States, 08046
      • Vanda Investigational Site
  • New York
    • 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
      • Vanda Investigational Site
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • Vanda Investigational Site
    • Dayton, Ohio, United States, 45417
      • Vanda Investigational Site
  • Oregon
    • Portland, Oregon, United States, 97210
      • Vanda Investigational Site
  • Rhode Island
    • Lincoln, Rhode Island, United States, 02865
      • Vanda Investigational Site
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Vanda Investigational Site
  • Texas
    • Austin, Texas, United States, 78731
      • Vanda Investigational Site
    • Dallas, Texas, United States, 75231
      • Vanda Investigational Site
  • Utah
    • Salt Lake City, Utah, United States, 84106
      • Vanda Investigational Site
  • Washington
    • Seattle, Washington, United States, 98104
      • Vanda Investigational Site
  • Wisconsin
    • Brown Deer, Wisconsin, United States, 53223
      • Vanda Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: placebo	Drug: placebo; once daily
EXPERIMENTAL: tasimelteon	Drug: tasimelteon; 20 mg once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Vanda Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (ACTUAL): January 1, 2013
• Study Completion (ACTUAL): May 1, 2013

Study Registration Dates

• First Submitted: August 31, 2011
• First Submitted That Met QC Criteria: September 2, 2011
• First Posted (ESTIMATE): September 5, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): June 19, 2015
• Last Update Submitted That Met QC Criteria: June 1, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: depression; MDD; Major Depressive Disorder; tasimelteon
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Pathologic Processes; Mood Disorders; Depression; Depressive Disorder; Disease; Depressive Disorder, Major
• Other Study ID Numbers: VP-VEC-162-2301