A Long Term Study of ALKS 5461 in the Treatment of Refractory Major Depressive Disorder (MDD)



Status:Enrolling by invitation
Conditions:Depression, Depression, Major Depression Disorder (MDD)
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 72
Updated:11/30/2018
Start Date:August 9, 2018
End Date:July 2021

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Trial Summary
Trial Overview
Inclusion Criteria

A Phase 3b Extension Study of Adjunctive ALKS 5461 in the Treatment of Refractory Major Depressive Disorder

This study will assess the long-term safety and tolerability of ALKS 5461 as an adjunctive
treatment for refractory MDD.


Inclusion Criteria:

- Completed study ALK5461-217

- Be willing to abide by the contraception requirements as outlined in the study
protocol

- Be willing and able to follow the study procedures and visits as outlined in the
protocol

- Additional criteria may apply

Exclusion Criteria:

- Pregnant, planning to become pregnant, or breastfeeding

- A positive urine drug test for drugs of abuse

- Poses a current suicide risk

- Additional criteria may apply
We found this trial at
24
sites
Alkermes Investigational Site
Allentown, Pennsylvania 18104
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Allentown, PA
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Alkermes Study Site
Atlanta, Georgia 30308
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Atlanta, GA
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Alkermes Investigational Site
Canton, Ohio 44718
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Canton, OH
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Alkermes Investigational Site
Cincinnati, Ohio
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Cincinnati, OH
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Alkermes Investigational Site
Desoto, Texas 75115
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Desoto, TX
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Alkermes Investigational Site
Hollywood, Florida 33024
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Hollywood, FL
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Alkermes Investigational Site
Jacksonville, Florida 32256
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Jacksonville, FL
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Alkermes Investigational Site
Jamaica, New York
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Jamaica, NY
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Alkermes Study Site
Little Rock, Arkansas 72211
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Little Rock, AR
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Alkermes Investigational Site
Los Alamitos, California
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Los Alamitos, CA
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Alkermes Investigational Site
Memphis, Tennessee 38119
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Memphis, TN
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Alkermes Investigational Site
Mount Kisco, New York
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Mount Kisco, NY
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Alkermes Investigational Site
North Miami, Florida
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North Miami, FL
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Alkermes Investigational Site
O'Fallon, Missouri
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O'Fallon, MO
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Alkermes Investigational Site
Oceanside, California 92056
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Oceanside, CA
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Alkermes Investigational Site
Oklahoma City, Oklahoma
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Oklahoma City, OK
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Alkermes Investigational Site
Orlando, Florida 32810
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Orlando, FL
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Alkermes Investigational Site
Pico Rivera, California 90660
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Pico Rivera, CA
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Alkermes Investigational Site
Pikesville, Maryland 21208
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Pikesville, MD
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Alkermes Investigational Site
Redlands, California
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Redlands, CA
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Alkermes Investigational Site
San Juan, 00918
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San Juan,
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Alkermes Investigational Site
Sherman Oaks, California
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Sherman Oaks, CA
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Alkermes Investigational Site
Temecula, California
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Temecula, CA
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Alkermes' Investigational Study Site
Tucson, Arizona 85712
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Tucson, AZ
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