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

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
tasimelteon
placebo
Sponsored by
Vanda Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring tasimelteon, Major Depressive Disorder, MDD, depression

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

tasimelteon

placebo

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
August 31, 2011
Last Updated
June 1, 2015
Sponsor
Vanda Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01428661
Brief Title
Melatonin Agonist Effects of Tasimelteon Versus Placebo in Patients With Major Depressive Disorder
Acronym
MAGELLAN
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 Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vanda Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
tasimelteon, Major Depressive Disorder, MDD, depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
507 (Actual)

8. Arms, Groups, and Interventions

Arm Title
tasimelteon
Arm Type
Experimental
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
tasimelteon
Intervention Description
20 mg once daily
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
once daily
Primary Outcome Measure Information:
Title
Change From Baseline to Endpoint at Week 8 Using the Total Score of the Hamilton Depression Rating Scale (HAM-D)
Description
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.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Vanda Investigational Site
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Facility Name
Vanda Investigational Site
City
Irvine
State/Province
California
ZIP/Postal Code
92617
Country
United States
Facility Name
Vanda Investigational Site
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720
Country
United States
Facility Name
Vanda Investigational Site
City
Oakland
State/Province
California
ZIP/Postal Code
94612
Country
United States
Facility Name
Vanda Investigational Site
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Vanda Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92102
Country
United States
Facility Name
Vanda Investigational Site
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Facility Name
Vanda Investigational Site
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Vanda Investigational Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80239
Country
United States
Facility Name
Vanda Investigational Site
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34201
Country
United States
Facility Name
Vanda Investigational Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Vanda Investigational Site
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Vanda Investigational Site
City
N. Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
Vanda Investigational Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Vanda Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Vanda Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Vanda Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
Vanda Investigational Site
City
Joliet
State/Province
Illinois
ZIP/Postal Code
60435
Country
United States
Facility Name
Vanda Investigational Site
City
Prairie Village
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Facility Name
Vanda Investigational Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21208
Country
United States
Facility Name
Vanda Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Facility Name
Vanda Investigational Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
Vanda Investigational Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Vanda Investigational Site
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
Vanda Investigational Site
City
Willingboro
State/Province
New Jersey
ZIP/Postal Code
08046
Country
United States
Facility Name
Vanda Investigational Site
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
Facility Name
Vanda Investigational Site
City
Mt. Kisco
State/Province
New York
ZIP/Postal Code
10549
Country
United States
Facility Name
Vanda Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10168
Country
United States
Facility Name
Vanda Investigational Site
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Vanda Investigational Site
City
Staten Island
State/Province
New York
ZIP/Postal Code
10312
Country
United States
Facility Name
Vanda Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Vanda Investigational Site
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Facility Name
Vanda Investigational Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Vanda Investigational Site
City
Lincoln
State/Province
Rhode Island
ZIP/Postal Code
02865
Country
United States
Facility Name
Vanda Investigational Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Vanda Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Vanda Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Vanda Investigational Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
Facility Name
Vanda Investigational Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Vanda Investigational Site
City
Brown Deer
State/Province
Wisconsin
ZIP/Postal Code
53223
Country
United States

12. IPD Sharing Statement

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

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