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
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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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Bellevue, Washington 98007
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Berlin, New Jersey
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Canton, Ohio 44718
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Dallas, Texas 75231
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Decatur, Georgia 30030
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Desoto, Texas 75115
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Flowood, Mississippi 39232
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Frankston, Victoria 3199
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Hoffman Estates, Illinois 60169
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Hollywood, Florida 33024
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Houston, Texas 77007
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Jacksonville, Florida 32256
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Jamaica, New York
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Lincoln, Rhode Island
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Little Rock, Arkansas 72211
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Los Alamitos, California
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Memphis, Tennessee 38119
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Miami, Florida 33136
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Mount Kisco, New York
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O'Fallon, Missouri
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Oceanside, California 92056
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Orlando, Florida 32810
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Palm Bay, Florida 32905
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Pico Rivera, California 90660
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Pikesville, Maryland 21208
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Redlands, California
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Richardson, Texas 75080
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San Diego, California 92123
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Santa Ana, California 92701
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Sherman Oaks, California
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Tucson, Arizona 85712
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Upland, California 91786
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Woodstock, Vermont
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