Melatonin Agonist Effects of Tasimelteon Versus Placebo in Patients With Major Depressive Disorder
NCT ID: NCT01428661
Last Updated: 2015-06-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
507 participants
INTERVENTIONAL
2011-09-30
2013-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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tasimelteon
tasimelteon
20 mg once daily
placebo
placebo
once daily
Interventions
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tasimelteon
20 mg once daily
placebo
once daily
Eligibility Criteria
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Inclusion Criteria
* Current episode ≥4 weeks and ≤1 year;
* CGI-Severity score ≥4 at screening and baseline.
Exclusion Criteria
* 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;
18 Years
65 Years
ALL
No
Sponsors
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Vanda Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Vanda Investigational Site
Garden Grove, California, United States
Vanda Investigational Site
Irvine, California, United States
Vanda Investigational Site
Los Alamitos, California, United States
Vanda Investigational Site
Oakland, California, United States
Vanda Investigational Site
Oceanside, California, United States
Vanda Investigational Site
San Diego, California, United States
Vanda Investigational Site
Sherman Oaks, California, United States
Vanda Investigational Site
Torrance, California, United States
Vanda Investigational Site
Denver, Colorado, United States
Vanda Investigational Site
Bradenton, Florida, United States
Vanda Investigational Site
Jacksonville, Florida, United States
Vanda Investigational Site
Maitland, Florida, United States
Vanda Investigational Site
North Miami, Florida, United States
Vanda Investigational Site
Orlando, Florida, United States
Vanda Investigational Site
Atlanta, Georgia, United States
Vanda Investigational Site
Atlanta, Georgia, United States
Vanda Investigational Site
Chicago, Illinois, United States
Vanda Investigational Site
Joliet, Illinois, United States
Vanda Investigational Site
Prairie Village, Kansas, United States
Vanda Investigational Site
Baltimore, Maryland, United States
Vanda Investigational Site
Boston, Massachusetts, United States
Vanda Investigational Site
Omaha, Nebraska, United States
Vanda Investigational Site
Las Vegas, Nevada, United States
Vanda Investigational Site
Toms River, New Jersey, United States
Vanda Investigational Site
Willingboro, New Jersey, United States
Vanda Investigational Site
Brooklyn, New York, United States
Vanda Investigational Site
Mount Kisco, New York, United States
Vanda Investigational Site
New York, New York, United States
Vanda Investigational Site
Rochester, New York, United States
Vanda Investigational Site
Staten Island, New York, United States
Vanda Investigational Site
Cincinnati, Ohio, United States
Vanda Investigational Site
Dayton, Ohio, United States
Vanda Investigational Site
Portland, Oregon, United States
Vanda Investigational Site
Lincoln, Rhode Island, United States
Vanda Investigational Site
Memphis, Tennessee, United States
Vanda Investigational Site
Austin, Texas, United States
Vanda Investigational Site
Dallas, Texas, United States
Vanda Investigational Site
Salt Lake City, Utah, United States
Vanda Investigational Site
Seattle, Washington, United States
Vanda Investigational Site
Brown Deer, Wisconsin, United States
Countries
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Other Identifiers
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VP-VEC-162-2301
Identifier Type: -
Identifier Source: org_study_id
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