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
Skokie, Illinois
1723
mi
from 98109
Skokie, IL
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Alkermes Investigational Site
Albuquerque, New Mexico
1186
mi
from 98109
Albuquerque, NM
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Alkermes Investigational Site
Allentown, Pennsylvania 18104
2336
mi
from 98109
Allentown, PA
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Alkermes, Investigational Site
Alpharetta, Georgia 30005
2169
mi
from 98109
Alpharetta, GA
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Alkermes Study Site
Atlanta, Georgia 30308
2178
mi
from 98109
Atlanta, GA
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Alkermes Study Site
Austin, Texas 78731
1770
mi
from 98109
Austin, TX
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Alkermes Investigational Site
Baltimore, Maryland 21285
2328
mi
from 98109
Baltimore, MD
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Alkermes Investigational Site
Baltimore, Maryland 21285
2328
mi
from 98109
Baltimore, MD
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Alkermes Investigational Site
Beachwood, Ohio
2030
mi
from 98109
Beachwood, OH
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Alkermes Investigational Site
Bellevue, Washington 98007
7
mi
from 98109
Bellevue, WA
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Alkermes Investigational Site
Bellflower, California 90706
975
mi
from 98109
Bellflower, CA
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Alkermes Investigational Site
Belmont, Massachusetts 02478
2478
mi
from 98109
Belmont, MA
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Alkermes Investigational Site
Berlin, New Jersey
2389
mi
from 98109
Berlin, NJ
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Alkermes Investigational Site
Beverly Hills, California
958
mi
from 98109
Beverly Hills, CA
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Alkermes Investigational Site
Birmingham, Alabama
2079
mi
from 98109
Birmingham, AL
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Alkermes Investigational Site
Birmingham, Alabama
2079
mi
from 98109
Birmingham, AL
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Alkermes Investigational Site
Bradenton, Florida 34201
2552
mi
from 98109
Bradenton, FL
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Alkermes Investigational Site
Brockton, Massachusetts
2495
mi
from 98109
Brockton, MA
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Alkermes Investigational Site
Brooklyn, New York
2406
mi
from 98109
Brooklyn, NY
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Alkermes Investigational Site
Canton, Ohio 44718
2057
mi
from 98109
Canton, OH
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Alkermes Investigational Site
Carson, California
976
mi
from 98109
Carson, CA
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Alkermes Study Site
Charleston, South Carolina 29407
2423
mi
from 98109
Charleston, SC
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Alkermes Investigational Site
Charlotte, North Carolina 28204
2282
mi
from 98109
Charlotte, NC
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Alkermes Investigational Site
Cherry Hill, New Jersey
2380
mi
from 98109
Cherry Hill, NJ
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Alkermes Study Site
Chicago, Illinois 60611
1733
mi
from 98109
Chicago, IL
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Alkermes Study Site
Chicago, Illinois 60611
1733
mi
from 98109
Chicago, IL
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Alkermes Investigational Site
Cincinnati, Ohio
1967
mi
from 98109
Cincinnati, OH
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Alkermes Investigational Site
Cincinnati, Ohio
1967
mi
from 98109
Cincinnati, OH
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Alkermes Investigational Site
Clinton, Utah
676
mi
from 98109
Clinton, UT
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Alkermes Investigational Site
Colorado Springs, Colorado
1067
mi
from 98109
Colorado Springs, CO
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Alkermes Investigational Site
Coral Springs, Florida
2704
mi
from 98109
Coral Springs, FL
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Alkermes Investigational Site
Dallas, Texas 75231
1677
mi
from 98109
Dallas, TX
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Alkermes Investigational Site
Dallas, Texas 75231
1677
mi
from 98109
Dallas, TX
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Alkermes Investigational Site
Dayton, Ohio 45417
1956
mi
from 98109
Dayton, OH
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Alkermes Investigational Site
Decatur, Georgia 30030
2182
mi
from 98109
Decatur, GA
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Alkermes Investigational Site
Deerfield, Illinois 60015
1714
mi
from 98109
Deerfield, IL
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Alkermes Investigational Site
Denver, Colorado
1020
mi
from 98109
Denver, CO
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Alkermes Investigational Site
Desoto, Texas 75115
1687
mi
from 98109
Desoto, TX
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Alkermes Investigational Site
Edgewood, Kentucky
1966
mi
from 98109
Edgewood, KY
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Alkermes Investigational Site
Flowood, Mississippi 39232
1985
mi
from 98109
Flowood, MS
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Alkermes Investigational Site
Fort Myers, Florida 33912
2615
mi
from 98109
Fort Myers, FL
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Alkermes Investigational Site
Gainesville, Florida 32607
2449
mi
from 98109
Gainesville, FL
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Alkermes Investigational Site
Garden Grove, California 92845
982
mi
from 98109
Garden Grove, CA
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Alkermes Investigational Site
Glendale, California
955
mi
from 98109
Glendale, CA
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Alkermes Investigational Site
Hallandale Beach, Florida
2723
mi
from 98109
Hallandale Beach, FL
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Alkermes Investigational Site
Hartford, Connecticut 06106
2429
mi
from 98109
Hartford, CT
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Alkermes Investigational Site
Hialeah, Florida 33016
2719
mi
from 98109
Hialeah, FL
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Alkermes Investigational Site
High Point, North Carolina 27265
2289
mi
from 98109
High Point, NC
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Alkermes Investigational Site
Hoffman Estates, Illinois 60169
1704
mi
from 98109
Hoffman Estates, IL
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Alkermes Investigational Site
Houston, Texas 77007
1887
mi
from 98109
Houston, TX
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Alkermes Investigational Site
Houston, Texas 77007
1887
mi
from 98109
Houston, TX
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Alkermes Investigational Site
Indianapolis, Indiana
1868
mi
from 98109
Indianapolis, IN
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Alkermes Investigational Site
Jacksonville, Florida 32256
2462
mi
from 98109
Jacksonville, FL
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Alkermes Investigational Site
Jacksonville, Florida 32256
2462
mi
from 98109
Jacksonville, FL
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Alkermes Investigational Site
Jamaica, New York
2412
mi
from 98109
Jamaica, NY
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Alkermes Investigational Site
Joliet, Illinois
1722
mi
from 98109
Joliet, IL
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Alkermes Investigational Site
Lafayette, Indiana
1813
mi
from 98109
Lafayette, IN
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Alkermes Investigational Site
Lauderhill, Florida 33161
2726
mi
from 98109
Lauderhill, FL
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Alkermes Investigational Site
Lincoln, Rhode Island
2481
mi
from 98109
Lincoln, RI
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Alkermes Study Site
Little Rock, Arkansas 72211
1782
mi
from 98109
Little Rock, AR
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Alkermes Investigational Site
Los Alamitos, California
981
mi
from 98109
Los Alamitos, CA
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Alkermes Investigational Site
Los Angeles, California
962
mi
from 98109
Los Angeles, CA
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Alkermes Investigational Site
Maitland, Florida 32751
2543
mi
from 98109
Maitland, FL
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Alkermes' Investigational Study Site
Mason, Ohio 45040
1968
mi
from 98109
Mason, OH
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Alkermes Investigational Site
Media, Pennsylvania
2364
mi
from 98109
Media, PA
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Alkermes Investigational Site
Melbourne, Florida
2603
mi
from 98109
Melbourne, FL
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Alkermes Investigational Site
Memphis, Tennessee 38119
1876
mi
from 98109
Memphis, TN
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Alkermes Investigational Site
Memphis, Tennessee 38119
1876
mi
from 98109
Memphis, TN
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Alkermes Investigational Site
Middleburg Heights, Ohio
2019
mi
from 98109
Middleburg Heights, OH
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Alkermes Investigational Site
Middleton, Wisconsin
1611
mi
from 98109
Middleton, WI
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Alkermes Investigational Site
Mount Kisco, New York
2399
mi
from 98109
Mount Kisco, NY
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Alkermes Investigational Site
National City, California 91950
1069
mi
from 98109
National City, CA
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Alkermes Investigational Site
New York, New York 10021
2401
mi
from 98109
New York, NY
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Alkermes Investigational Site
New York, New York 10021
2401
mi
from 98109
New York, NY
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Alkermes Investigational Site
New York, New York 10021
2401
mi
from 98109
New York, NY
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Alkermes Investigational Site
New York, New York 10021
2401
mi
from 98109
New York, NY
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Alkermes Investigational Site
New York, New York 10021
2401
mi
from 98109
New York, NY
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Alkermes Investigational Site
Newburgh, Indiana 47630
1874
mi
from 98109
Newburgh, IN
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Alkermes Investigational Site
North Miami, Florida
2726
mi
from 98109
North Miami, FL
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Alkermes Investigational Site
Norwich, Connecticut
2465
mi
from 98109
Norwich, CT
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Alkermes Investigational Site
O'Fallon, Missouri
1691
mi
from 98109
O'Fallon, MO
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Alkermes Investigational Site
Oak Brook, Illinois
1719
mi
from 98109
Oak Brook, IL
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Alkermes Investigational Site
Oakland, California 94612
678
mi
from 98109
Oakland, CA
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Alkermes Investigational Site
Oakland Park, Florida 33334
2714
mi
from 98109
Oakland Park, FL
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Alkermes Investigational Site
Oceanside, California 92056
1031
mi
from 98109
Oceanside, CA
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Alkermes Investigational Site
Oklahoma City, Oklahoma
1523
mi
from 98109
Oklahoma City, OK
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Alkermes Investigational Site
Oklahoma City, Oklahoma
1523
mi
from 98109
Oklahoma City, OK
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Alkermes Investigational Site
Orange, California 92868
984
mi
from 98109
Orange, CA
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Alkermes Investigational Site
Orlando, Florida 32810
2541
mi
from 98109
Orlando, FL
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Alkermes Investigational Site
Owensboro, Kentucky
1894
mi
from 98109
Owensboro, KY
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Alkermes Study Site
Philadelphia, Pennsylvania 19131
2373
mi
from 98109
Philadelphia, PA
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Alkermes Study Site
Philadelphia, Pennsylvania 19131
2373
mi
from 98109
Philadelphia, PA
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Alkermes Investigational Site
Pico Rivera, California 90660
968
mi
from 98109
Pico Rivera, CA
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Alkermes Investigational Site
Portland, Oregon
146
mi
from 98109
Portland, OR
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Alkermes Investigational Site
Portland, Oregon
146
mi
from 98109
Portland, OR
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Alkermes Investigational Site
Princeton, New Jersey
2383
mi
from 98109
Princeton, NJ
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Alkermes Investigational Site
Redlands, California
975
mi
from 98109
Redlands, CA
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Alkermes Investigational Site
Saint Charles, Missouri 63304
1697
mi
from 98109
Saint Charles, MO
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Alkermes Investigational Site
Saint Louis, Missouri 63104
1721
mi
from 98109
Saint Louis, MO
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Alkermes Investigational Site
Salem, Oregon
188
mi
from 98109
Salem, OR
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Alkermes Investigational Site
San Antonio, Texas
1787
mi
from 98109
San Antonio, TX
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