A Study of ALKS 5461 for Treatment Refractory Major Depressive Disorder (MDD)
NCT ID: NCT03188185
Last Updated: 2021-04-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
278 participants
INTERVENTIONAL
2017-06-12
2020-03-05
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
Sublingual tablets
ALKS 5461
Samidorphan + buprenorphine, administered sublingually
ALKS 5461 Placebo
Sublingual tablets
ALKS 5461 Placebo
Placebo tablet, administered sublingually
Interventions
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ALKS 5461
Samidorphan + buprenorphine, administered sublingually
ALKS 5461 Placebo
Placebo tablet, administered sublingually
Eligibility Criteria
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Inclusion Criteria
* Have a body mass index (BMI) of 18.0 to \</= 40.0 kg/m\^2
* Be willing and able to follow the study procedures and visits as outlined in the protocol (including agreeing not to enroll in any other clinical trials)
* Have inadequate responses to antidepressant therapy (ADT) in the current Major Depressive Episode (MDE)
* Additional criteria may apply
Exclusion Criteria
* Has any other significant medical condition (eg, neurological, psychiatric, or metabolic) or clinical symptom that could unduly risk the subject or affect the interpretation of study data
* Has any current primary diagnosis other than MDD, where primary diagnosis is defined as the primary source of current distress and functional impairment
* Has experienced hallucinations, delusions, or any psychotic symptoms in the current MDE
* Has been hospitalized for MDD within 3 months before screening
* Has used opioid agonists (eg, codeine, oxycodone, tramadol, morphine) or opioid antagonists (eg, naloxone, naltrexone) within 14 days prior to screening
* Has received electroconvulsive therapy treatment within the last 2 years or within the current MDE or failed a course of electroconvulsive treatment at any time
* Has a significant risk for suicide
* Has a positive breath alcohol test at screening
* Has a positive test for drugs of abuse at screening or visit 2
* Is pregnant, planning to become pregnant, or is breastfeeding during the study
* 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
Tucson, Arizona, United States
Alkermes Investigational Site
Little Rock, Arkansas, United States
Alkermes Investigational Site
Los Alamitos, California, United States
Alkermes Investigational Site
Oceanside, California, United States
Alkermes Investigational Site
Pico Rivera, California, United States
Alkermes Investigational Site
Redlands, California, United States
Alkermes Investigational Site
Santa Ana, California, United States
Alkermes Investigational Site
Sherman Oaks, California, United States
Alkermes Investigational Site
Temecula, California, United States
Alkermes Investigative Site
Upland, California, United States
Alkermes Investigational Site
Hollywood, Florida, United States
Alkermes Investigational Site
Jacksonville, Florida, United States
Alkermes Investigational Site
Lauderhill, Florida, United States
Alkermes Investigational Site
Orlando, Florida, United States
Alkermes Investigative Site
Palm Bay, Florida, United States
Alkermes Investigational Site
Atlanta, Georgia, United States
Alkermes Investigational Site
Decatur, Georgia, United States
Alkermes Investigational Site
Pikesville, Maryland, United States
Alkermes Investigational Site
O'Fallon, Missouri, United States
Alkermes Investigational Site
Jamaica, New York, United States
Alkermes Investigational Site
Mount Kisco, New York, United States
Alkermes Investigational Site
Canton, Ohio, United States
Alkermes Investigational Site
Cincinnati, Ohio, United States
Alkermes Investigational Site
Oklahoma City, Oklahoma, United States
Alkermes Investigational Site
Allentown, Pennsylvania, United States
Alkermes Investigational Site
Memphis, Tennessee, United States
Alkermes Investigational Site
Dallas, Texas, United States
Alkermes Investigational Site
DeSoto, Texas, United States
Alkermes Investigational Site
Woodstock, Vermont, United States
Alkermes Investigative Site
Bellevue, Washington, United States
Alkermes Investigational Site
Frankston, Victoria, Australia
Alkermes Investigational Site
Noble Park, Victoria, Australia
Alkermes Investigational Site
Richmond, Victoria, Australia
Alkermes Investigational Site
San Juan, , Puerto Rico
Alkermes Investigational Site
San Juan, , Puerto Rico
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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ALK5461-217
Identifier Type: -
Identifier Source: org_study_id
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