A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - the FORWARD-4 Study
NCT ID: NCT02158533
Last Updated: 2019-08-14
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
385 participants
INTERVENTIONAL
2014-05-31
2015-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - the FORWARD-3 Study
NCT02158546
A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - FORWARD-5 Study
NCT02218008
A Study of Different Titration Schedules of ALKS 5461 in Adults With Major Depressive Disorder (MDD)
NCT02085135
A Long-Term Safety Study of ALKS 5461
NCT02141399
A Study of ALKS 5461 for Treatment Refractory Major Depressive Disorder (MDD)
NCT03188185
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
High Dose
High Dose ALKS 5461
Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant)
Low Dose
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
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant)
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
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
Meet the organizations funding or collaborating on the study and learn about their roles.
Alkermes, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sanjeev Pathak, MD
Role: STUDY_DIRECTOR
Alkermes, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Alkermes Investigational Site
Birmingham, Alabama, United States
Alkermes Investigational Site
Tucson, Arizona, United States
Alkermes Investigational Site
Carson, California, United States
Alkermes Investigational Site
National City, California, United States
Alkermes Investigational Site
Orange, California, United States
Alkermes Investigational Site
Sherman Oaks, California, United States
Alkermes Investigational Site
Torrance, California, United States
Alkermes Investigational Site
Upland, California, United States
Alkermes Investigational Site
Hartford, Connecticut, United States
Alkermes Investigational Site
Norwich, Connecticut, United States
Alkermes Investigational Site
Coral Springs, Florida, United States
Alkermes Investigational Site
Gainesville, Florida, United States
Alkermes Investigational Site
Lauderhill, Florida, United States
Alkermes Investigational Site
Orlando, Florida, United States
Alkermes, Investigational Site
Alpharetta, Georgia, United States
Alkermes Investigational Site
Decatur, Georgia, United States
Alkermes Investigational Site
Chicago, Illinois, United States
Alkermes Investigational Site
Joliet, Illinois, United States
Alkermes Investigational Site
Skokie, Illinois, United States
Alkermes Investigational Site
Newburgh, Indiana, United States
Alkermes Investigational Site
Valparaiso, Indiana, United States
Alkermes Investigational Site
Owensboro, Kentucky, United States
Alkermes Investigational Site
Baltimore, Maryland, United States
Alkermes Investigational Site
Baltimore, Maryland, United States
Alkermes Investigational Site
Berlin, New Jersey, United States
Alkermes Investigational Site
Brooklyn, New York, United States
Alkermes Investigational Site
Mount Kisco, 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
Canton, Ohio, United States
Alkermes Investigational Site
Dayton, Ohio, United States
Alkermes Investigational Site
Oklahoma City, Oklahoma, United States
Alkermes Investigational Site
Oklahoma City, Oklahoma, United States
Alkermes Investigational Site
Allentown, Pennsylvania, United States
Alkermes Investigational Site
Media, Pennsylvania, United States
Alkermes Investigational Site
Philadelphia, Pennsylvania, United States
Alkermes Investigational Site
Lincoln, Rhode Island, United States
Alkermes Investigational Site
Austin, Texas, United States
Alkermes Investigational Site
Houston, Texas, United States
Alkermes Investigational Site
San Antonio, Texas, United States
Alkermes Investigational Site
Woodstock, Vermont, United States
Alkermes Investigational Site
Middleton, Wisconsin, United States
Alkermes Investigational Site
Brisbane, Queensland, Australia
Alkermes Investigational Site
Towong, Queensland, Australia
Alkermes Investigational Site
Frankston, Victoria, Australia
Alkermes Investigational Site
Melbourne, Victoria, Australia
Alkermes Investigational Site
Penticton, British Columbia, Canada
Alkermes Investigational Site
Gatineau, Quebec, Canada
Alkermes Investigational Site
Québec, , Canada
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ALK5461-205
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.