A Study of ALKS 5461 for Treatment Refractory Major Depressive Disorder (MDD)



Status:Recruiting
Conditions:Depression, Depression, Major Depression Disorder (MDD)
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 70
Updated:3/22/2019
Start Date:June 12, 2017
End Date:August 2021
Contact:Jean-Francois Gagne
Email:Jean-Francois.Gagne@INCResearch.com
Phone:919-257-6569

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A Phase 3b Efficacy and Safety Study of Adjunctive ALKS 5461 in Treatment Refractory Major Depressive Disorder

This study will evaluate the efficacy, safety, and tolerability of adjunctive ALKS 5461 in
adults who have treatment refractory MDD.


Inclusion Criteria:

- Have a Major Depressive Disorder (MDD) primary diagnosis

- Have a body mass index (BMI) of 18.0 to
- Be willing and able to follow the study procedures and visits as outlined in the
protocol (including agreeing not to enroll in any other clinical trials)

- Have inadequate responses to antidepressant therapy (ADT) in the current Major
Depressive Episode (MDE)

- Additional criteria may apply

Exclusion Criteria:

- Has any finding that would compromise the safety of the subject or affect their
ability to adhere to the protocol visit schedule or fulfill visit requirements

- Has any other significant medical condition (eg, neurological, psychiatric, or
metabolic) or clinical symptom that could unduly risk the subject or affect the
interpretation of study data

- Has any current primary diagnosis other than MDD, where primary diagnosis is defined
as the primary source of current distress and functional impairment

- Has experienced hallucinations, delusions, or any psychotic symptoms in the current
MDE

- Has been hospitalized for MDD within 3 months before screening

- Has used opioid agonists (eg, codeine, oxycodone, tramadol, morphine) or opioid
antagonists (eg, naloxone, naltrexone) within 14 days prior to screening

- Has received electroconvulsive therapy treatment within the last 2 years or within the
current MDE or failed a course of electroconvulsive treatment at any time

- Has a significant risk for suicide

- Has a positive breath alcohol test at screening

- Has a positive test for drugs of abuse at screening or visit 2

- Is pregnant, planning to become pregnant, or is breastfeeding during the study

- Additional criteria may apply
We found this trial at
39
sites
Oceanside, California 92056
1945
mi
from 43215
Oceanside, CA
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Allentown, Pennsylvania 18104
399
mi
from 43215
Allentown, PA
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Alpharetta, Georgia 30005
412
mi
from 43215
Alpharetta, GA
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Bellevue, Washington 98007
2000
mi
from 43215
Bellevue, WA
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Berlin, New Jersey
429
mi
from 43215
Berlin, NJ
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Canton, Ohio 44718
104
mi
from 43215
Canton, OH
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99
mi
from 43215
Cincinnati, OH
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Dallas, Texas 75231
905
mi
from 43215
Dallas, TX
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Decatur, Georgia 30030
433
mi
from 43215
Decatur, GA
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Desoto, Texas 75115
922
mi
from 43215
Desoto, TX
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Flowood, Mississippi 39232
660
mi
from 43215
Flowood, MS
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Frankston, Victoria 3199
9881
mi
from 43215
Frankston,
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Hoffman Estates, Illinois 60169
302
mi
from 43215
Hoffman Estates, IL
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Hollywood, Florida 33024
978
mi
from 43215
Hollywood, FL
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Houston, Texas 77007
992
mi
from 43215
Houston, TX
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Jacksonville, Florida 32256
678
mi
from 43215
Jacksonville, FL
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Jamaica, New York
488
mi
from 43215
Jamaica, NY
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Lauderhill, Florida 33161
986
mi
from 43215
Lauderhill, FL
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Lincoln, Rhode Island
618
mi
from 43215
Lincoln, RI
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Little Rock, Arkansas 72211
622
mi
from 43215
Little Rock, AR
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Los Alamitos, California
1969
mi
from 43215
Los Alamitos, CA
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Memphis, Tennessee 38119
503
mi
from 43215
Memphis, TN
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Miami, Florida 33136
992
mi
from 43215
Miami, FL
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Mount Kisco, New York
494
mi
from 43215
Mount Kisco, NY
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O'Fallon, Missouri
417
mi
from 43215
O'Fallon, MO
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Oklahoma City, Oklahoma
849
mi
from 43215
Oklahoma City, OK
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Orlando, Florida 32810
788
mi
from 43215
Orlando, FL
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Palm Bay, Florida 32905
?
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from 43215
Palm Bay, FL
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Pico Rivera, California 90660
1966
mi
from 43215
Pico Rivera, CA
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Pikesville, Maryland 21208
336
mi
from 43215
Pikesville, MD
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Redlands, California
1915
mi
from 43215
Redlands, CA
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Richardson, Texas 75080
901
mi
from 43215
Richardson, TX
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San Diego, California 92123
1947
mi
from 43215
San Diego, CA
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Santa Ana, California 92701
1960
mi
from 43215
Santa Ana, CA
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Sherman Oaks, California
1980
mi
from 43215
Sherman Oaks, CA
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Temecula, California
1929
mi
from 43215
Temecula, CA
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Tucson, Arizona 85712
1636
mi
from 43215
Tucson, AZ
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Upland, California 91786
1940
mi
from 43215
Upland, CA
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Woodstock, Vermont
596
mi
from 43215
Woodstock, VT
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