A Long-Term Safety Study of ALKS 5461



Status:Completed
Conditions:Depression, Depression, Major Depression Disorder (MDD)
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 70
Updated:12/16/2018
Start Date:May 2014
End Date:November 20, 2017

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Trial Summary
Trial Overview
Inclusion Criteria

A Phase 3 Multicenter Study of the Long-Term Safety and Tolerability of ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder in Adults Who Have an Inadequate Response to Antidepressant Therapy (the FORWARD-2 Study)

This is a 52-week open-label study to evaluate the safety and tolerability of ALKS 5461.


Inclusion Criteria:

- Agree to use an approved method of contraception for the duration of the study

- Have the potential to safely benefit from the administration of ALKS 5461

- Have a diagnosis of major depressive disorder (MDD)

- Additional criteria may apply

Exclusion Criteria:

- Have a positive test for drugs of abuse

- Currently pregnant or breastfeeding

- Have a current primary Axis-I disorder other than MDD

- 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 1 course of electroconvulsive treatment during their lifetime

- Have attempted suicide within the past 2 years

- 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 the past 60 days

- Additional criteria may apply
We found this trial at
125
sites
Alkermes Investigational Site
Worcester, Massachusetts 01605
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Albuquerque, New Mexico
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Allentown, Pennsylvania 18104
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Alpharetta, Georgia 30005
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Atlanta, Georgia 30308
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Austin, Texas 78731
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Baltimore, Maryland 21285
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Baltimore, Maryland 21285
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Beachwood, Ohio
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Bellevue, Washington 98007
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Bellflower, California 90706
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Belmont, Massachusetts 02478
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Berlin, New Jersey
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Beverly Hills, California
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Birmingham, Alabama
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Birmingham, Alabama
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Bradenton, Florida 34201
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Brockton, Massachusetts
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Brooklyn, New York
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Canton, Ohio 44718
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Carson, California
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Charleston, South Carolina 29407
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Charlotte, North Carolina 28204
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Cherry Hill, New Jersey
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Chicago, Illinois 60611
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Chicago, Illinois 60611
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Cincinnati, Ohio
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Cincinnati, Ohio
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Clinton, Utah
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Colorado Springs, Colorado
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Coral Springs, Florida
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Dallas, Texas 75231
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Dallas, Texas 75231
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Dayton, Ohio 45417
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Decatur, Georgia 30030
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Deerfield, Illinois 60015
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Denver, Colorado
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Desoto, Texas 75115
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Edgewood, Kentucky
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Flowood, Mississippi 39232
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Fort Myers, Florida 33912
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Gainesville, Florida 32607
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Garden Grove, California 92845
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Glendale, California
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Hallandale Beach, Florida
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Hartford, Connecticut 06106
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Hialeah, Florida 33016
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High Point, North Carolina 27265
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Hoffman Estates, Illinois 60169
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Houston, Texas 77007
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Houston, Texas 77007
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Indianapolis, Indiana
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Jacksonville, Florida 32256
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Jacksonville, Florida 32256
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Jamaica, New York
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Joliet, Illinois
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Lafayette, Indiana
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Lauderhill, Florida 33161
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Lincoln, Rhode Island
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Little Rock, Arkansas 72211
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Los Alamitos, California
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Los Angeles, California
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Maitland, Florida 32751
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Mason, Ohio 45040
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Media, Pennsylvania
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Melbourne, Florida
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Memphis, Tennessee 38119
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Memphis, Tennessee 38119
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Middleburg Heights, Ohio
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Middleton, Wisconsin
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Mount Kisco, New York
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National City, California 91950
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New York, New York 10021
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New York, New York 10021
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New York, New York 10021
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New York, New York 10021
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New York, New York 10021
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Newburgh, Indiana 47630
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North Miami, Florida
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Norwich, Connecticut
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O'Fallon, Missouri
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Oak Brook, Illinois
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Oakland, California 94612
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Oakland Park, Florida 33334
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Oceanside, California 92056
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Oklahoma City, Oklahoma
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Oklahoma City, Oklahoma
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Orange, California 92868
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Orlando, Florida 32810
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Owensboro, Kentucky
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Philadelphia, Pennsylvania 19131
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Philadelphia, Pennsylvania 19131
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Pico Rivera, California 90660
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Portland, Oregon
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Portland, Oregon
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Princeton, New Jersey
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Redlands, California
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Saint Charles, Missouri 63304
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Saint Louis, Missouri 63104
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Salem, Oregon
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San Antonio, Texas
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