A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - the FORWARD-3 Study



Status:Completed
Conditions:Depression, Depression, Major Depression Disorder (MDD)
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 70
Updated:4/21/2016
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-3 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
51
sites
Hialeah, Florida 33016
2310
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from 91732
Hialeah, FL
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Albuquerque, New Mexico
652
mi
from 91732
Albuquerque, NM
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Atlanta, Georgia 30308
1919
mi
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Atlanta, GA
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2041
mi
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Beachwood, OH
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Bellevue, Washington 98007
959
mi
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Bellevue, WA
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Bellflower, California 90706
14
mi
from 91732
Bellflower, CA
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Beverly Hills, California
22
mi
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Beverly Hills, CA
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Bourgas,
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Brockton, Massachusetts
2581
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Brockton, MA
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Charleston, South Carolina 29407
2184
mi
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Charleston, SC
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Charlotte, North Carolina 28204
2102
mi
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Charlotte, NC
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Cherry Hill, New Jersey
2382
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Cherry Hill, NJ
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Chicago, Illinois 60611
1729
mi
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Chicago, IL
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1879
mi
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Cincinnati, OH
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1879
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Cincinnati, OH
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Dallas, Texas 75231
1225
mi
from 91732
Dallas, TX
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Dallas, Texas 75231
1225
mi
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Dallas, TX
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Edgewood, Kentucky
1875
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Edgewood, KY
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Glendale, California
14
mi
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Glendale, CA
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Hallandale Beach, Florida
2318
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Hallandale Beach, FL
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Houston, Texas 77007
1354
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Houston, TX
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Indianapolis, Indiana
1792
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Indianapolis, IN
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Jacksonville, Florida 32256
2138
mi
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Jacksonville, FL
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Jamaica, New York
2444
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Jamaica, NY
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Kansas City, Missouri
1341
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Kansas City, MO
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Lafayette, Indiana
1757
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Lafayette, IN
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Leesburg, Florida 34748
2149
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Leesburg, FL
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Little Rock, Arkansas 72211
1463
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Little Rock, AR
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Los Alamitos, California
18
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Los Alamitos, CA
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Maitland, Florida 32751
2183
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from 91732
Maitland, FL
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1890
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Mason, OH
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Memphis, Tennessee 38119
1598
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Memphis, TN
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Middleburg Heights, Ohio
2025
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Middleburg Heights, OH
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New York, New York 10021
2432
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New York, NY
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O'Fallon, Missouri
1546
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O'Fallon, MO
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Oak Brook, Illinois
1712
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Oak Brook, IL
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Orange, California 92868
21
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Orange, CA
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Philadelphia, Pennsylvania 19131
2375
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Philadelphia, PA
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828
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Portland, OR
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Redlands, California
47
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Redlands, CA
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796
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Salem, OR
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St. Louis, Missouri 63118
1573
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St. Louis, MO
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Staten Island, New York 10305
2429
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Staten Island, NY
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1057
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Sugarland, TX
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2136
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Tampa, FL
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Temecula, California
63
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Temecula, CA
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Vernon Hills, Illinois
1716
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Vernon Hills, IL
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Washington, District of Columbia 20016
2281
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Washington,
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Washington DC, Maryland 20016
2278
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Washington DC, MD
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Watertown, Massachusetts
2572
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Watertown, MA
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Waukesha, Wisconsin
1712
mi
from 91732
Waukesha, WI
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