A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - the FORWARD-4 Study



Status:Completed
Conditions:Depression, Depression, Major Depression Disorder (MDD)
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 70
Updated:3/29/2019
Start Date:May 2014
End Date:December 2015

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A Phase 3 Efficacy and Safety Study of ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder (the FORWARD-4 Study)

This study will evaluate the efficacy and safety of ALKS 5461.


Inclusion Criteria:

- Have a Body Mass Index (BMI) of 18.0 to 40.0 kg/m2, inclusive

- 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 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 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
We found this trial at
43
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Lauderhill, Florida 33161
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Allentown, Pennsylvania 18104
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Alpharetta, Georgia 30005
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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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Berlin, New Jersey
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Birmingham, Alabama
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Brisbane, Queensland
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Brooklyn, New York
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Canton, Ohio 44718
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Carson, California
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Chicago, Illinois 60611
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Chicago, IL
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Coral Springs, Florida
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Coral Springs, FL
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Dayton, Ohio 45417
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Decatur, Georgia 30030
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Gainesville, Florida 32607
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Hartford, Connecticut 06106
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Houston, Texas 77007
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Houston, TX
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Joliet, IL
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Lincoln, Rhode Island
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Media, Pennsylvania
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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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Newburgh, Indiana 47630
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Norwich, Connecticut
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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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San Antonio, Texas
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Sherman Oaks, California
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Skokie, IL
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Staten Island, New York 10305
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Torrance, California 90502
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Tucson, Arizona 85712
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Upland, California 91786
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Valparaiso, Indiana
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Woodstock, Vermont
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