A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - FORWARD-5 Study
NCT ID: NCT02218008
Last Updated: 2019-08-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
407 participants
INTERVENTIONAL
2014-07-31
2016-10-31
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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High Dose
ALKS 5461
Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant)
Low Dose
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 an 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 their 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
Birmingham, Alabama, United States
Alkermes Investigational Site
Colton, California, United States
Alkermes Investigational Site
Garden Grove, California, United States
Alkermes Investigational Site
Los Angeles, California, United States
Alkermes Investigational Site
Oakland, California, United States
Alkermes Investigational Site
Oceanside, California, United States
Alkermes Investigational Site
Pico Rivera, California, United States
Alkermes Investigational Site
San Gabriel, California, United States
Alkermes Investigational Site
Colorado Springs, Colorado, United States
Alkermes Investigational Site
Bradenton, Florida, United States
Alkermes Investigational Site
Fort Myers, Florida, United States
Alkermes Investigational Site
Melbourne, Florida, United States
Alkermes Investigational Site
North Miami, Florida, United States
Alkermes Investigational Site
Oakland Park, Florida, United States
Alkermes Investigational Site
Winter Haven, Florida, United States
Alkermes Investigational Site
Smyrna, Georgia, United States
Alkermes Investigational Site
Hoffman Estates, Illinois, United States
Alkermes Investigational Site
Flowood, Mississippi, United States
Alkermes Investigational Site
Saint Charles, Missouri, United States
Alkermes Investigational Site
St Louis, Missouri, United States
Alkermes Investigational Site
Princeton, New Jersey, United States
Alkermes Investigational Site
New York, New York, United States
Alkermes Investigational Site
High Point, North Carolina, United States
Alkermes Investigational Site
Canton, Ohio, United States
Alkermes Investigational Site
Portland, Oregon, United States
Alkermes Investigational Site
Memphis, Tennessee, United States
Alkermes Investigational Site
DeSoto, Texas, United States
Alkermes Investigational Site
Wichita Falls, Texas, United States
Alkermes Investigational Site
Clinton, Utah, United States
Alkermes Investigational Site
Bellevue, Washington, United States
Alkermes Investigational Site
Seattle, Washington, United States
Alkermes Investigational Site
Spokane, Washington, United States
Alkermes Investigational Site
Gatineau, , Canada
Alkermes Investigational Site
Halifax, , Canada
Alkermes Investigational Site
Penticton, , Canada
Alkermes Investigational Site
Québec, , Canada
Alkermes Investigational Site
Berlin, , Germany
Alkermes Investigational Site
Berlin, , Germany
Alkermes Investigational Site
Hanover, , Germany
Alkermes Investigational Site
Oranienburg, , Germany
Alkermes Investigational Site
Schwerin, , Germany
Alkermes Investigational Site
Stralsund, , Germany
Alkermes Investigational Site
San Juan, , Puerto Rico
Alkermes Investigational Site
San Juan, , Puerto Rico
Countries
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Related Links
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Study-specific website
Other Identifiers
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ALK5461-207
Identifier Type: -
Identifier Source: org_study_id
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