A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - the FORWARD-3 Study
NCT ID: NCT02158546
Last Updated: 2019-06-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
447 participants
INTERVENTIONAL
2014-05-31
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ALKS 5461
ALKS 5461
Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant)
Placebo
Placebo
Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant)
Interventions
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ALKS 5461
Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant)
Placebo
Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant)
Eligibility Criteria
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Inclusion Criteria
* Agree to use an acceptable method of contraception for the duration of the study
* Have a Major Depressive Disorder (MDD) primary diagnosis
* Have no more than 2 inadequate responses to antidepressant therapy (ADT) in the current Major Depressive Episode (MDE)
* Additional criteria may apply
Exclusion Criteria
* Have used opioid agonists (eg, codeine, oxycodone, tramadol, morphine) or opioid antagonists (eg, naloxone, naltrexone) within 14 days
* Have received electroconvulsive therapy treatment within the last 2 years or received more than one course of electroconvulsive treatment during lifetime
* Have attempted suicide within the past 2 years
* Have a positive test for drugs of abuse
* Are pregnant, planning to become pregnant, or breastfeeding
* Have a history of intolerance, allergy, or hypersensitivity to buprenorphine or opioid antagonists (eg, naltrexone, naloxone)
* Have had a significant blood loss or blood donation within 60 days
* Additional criteria may apply
18 Years
70 Years
ALL
No
Sponsors
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Alkermes, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Sanjeev Pathak, MD
Role: STUDY_DIRECTOR
Alkermes, Inc.
Locations
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Alkermes Investigational Site
Little Rock, Arkansas, United States
Alkermes Investigational Site
Bellflower, California, United States
Alkermes Investigational Site
Beverly Hills, California, United States
Alkermes Investigational Site
Glendale, California, United States
Alkermes Investigational Site
Los Alamitos, California, United States
Alkermes Investigational Site
Orange, California, United States
Alkermes Investigational Site
Redlands, California, United States
Alkermes Investigational Site
Temecula, California, United States
Alkermes Investigational Site
Washington D.C., District of Columbia, United States
Alkermes Investigational Site
Hallandale, Florida, United States
Alkermes Investigational Site
Hialeah, Florida, United States
Alkermes Investigational Site
Jacksonville, Florida, United States
Alkermes Investigational Site
Leesburg, Florida, United States
Alkermes Investigational Site
Maitland, Florida, United States
Alkermes Investigational Site
Tampa, Florida, United States
Alkermes Investigational Site
Atlanta, Georgia, United States
Alkermes Investigational Site
Chicago, Illinois, United States
Alkermes Investigational Site
Oak Brook, Illinois, United States
Alkermes Investigational Site
Vernon Hills, Illinois, United States
Alkermes Investigational Site
Indianapolis, Indiana, United States
Alkermes Investigational Site
Lafayette, Indiana, United States
Alkermes Investigational Site
Edgewood, Kentucky, United States
Alkermes Investigational
Washington DC, Maryland, United States
Alkermes Investigational Site
Brockton, Massachusetts, United States
Alkermes Investigational Site
Watertown, Massachusetts, United States
Alkermes Investigational Site
Kansas City, Missouri, United States
Alkermes Investigational Site
O'Fallon, Missouri, United States
Alkermes Investigational Site
St Louis, Missouri, United States
Alkermes Investigational Site
Cherry Hill, New Jersey, United States
Alkermes Investigational Site
Albuquerque, New Mexico, United States
Alkermes Investigational Site
Jamaica, New York, United States
Alkermes Investigational Site
New York, New York, United States
Alkermes Investigational Site
Staten Island, New York, United States
Alkermes Investigational Site
Charlotte, North Carolina, United States
Alkermes Investigational Site
Beachwood, Ohio, United States
Alkermes Investigational Site
Cincinnati, Ohio, United States
Alkermes Investigational Site
Cincinnati, Ohio, United States
Alkermes Investigational Site
Mason, Ohio, United States
Alkermes Investigational Site
Middleburg Heights, Ohio, United States
Alkermes Investigational Site
Portland, Oregon, United States
Alkermes Investigational Site
Salem, Oregon, United States
Alkermes Investigational Site
Philadelphia, Pennsylvania, United States
Alkermes Investigational Site
Charleston, South Carolina, United States
Alkermes Investigational Site
Memphis, Tennessee, United States
Alkermes Investigational Site
Dallas, Texas, United States
Alkermes Investigational Site
Dallas, Texas, United States
Alkermes Investigational Site
Houston, Texas, United States
Alkermes Investigational Site
Sugar Land, Texas, United States
Alkermes Investigational Site
Bellevue, Washington, United States
Alkermes Investigational Site
Waukesha, Wisconsin, United States
Alkermes Investigational Site
Burgas, , Bulgaria
Alkermes Investigational Site
Kazanlak, , Bulgaria
Alkermes Investigational Site
Sofia, , Bulgaria
Alkermes Investigational Site
Sofia, , Bulgaria
Alkermes Investigational Site
Sofia, , Bulgaria
Alkermes Investigational Site
Varna, , Bulgaria
Alkermes Investigational Site
Veliko Tarnovo, , Bulgaria
Alkermes Investigational Site
Vratsa, , Bulgaria
Countries
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Other Identifiers
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ALK5461-206
Identifier Type: -
Identifier Source: org_study_id
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