A Study of Different Titration Schedules of ALKS 5461 in Adults With Major Depressive Disorder (MDD)



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:February 2014
End Date:September 2014

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A Phase 3, Randomized, Double-blind Study to Evaluate the Safety and Tolerability of Two Titration Schedules for ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder in Adults With an Inadequate Response to Antidepressant Therapy (the FORWARD-1 Study)

This is a Phase 3 study designed to evaluate the safety and tolerability of two titration
schedules for ALKS 5461.


Inclusion Criteria:

- Body mass index of 18-40 kg/m2

- Have a diagnosis of MDD

- Have a current major depressive episode (MDE) lasting 8 weeks to 24 months

- Have been treated with an adequate dose of an approved antidepressant during the
current MDE for at least 8 weeks

- Have an inadequate response to current antidepressant treatment

- Agree to use an approved method of birth control for the duration of the study

- Additional criteria may apply

Exclusion Criteria:

- Currently pregnant or breastfeeding

- History of or current infection with Hepatitis B Virus, Hepatitis C Virus or Human
Immunodeficiency Virus (HIV)

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

- Have used opioid agonists (eg, codeine, oxycodone, tramadol, or morphine) or opioid
antagonists (eg, naloxone, naltrexone) within 14 days

- Have received electroconvulsive therapy treatment within the last 5 years

- Have attempted suicide within the past 2 years

- 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 with 60 days of screening

- Additional criteria may apply
We found this trial at
9
sites
Atlanta, Georgia 30308
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Allentown, Pennsylvania 18104
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Allentown, PA
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Bellevue, Washington 98007
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Dayton, Ohio 45417
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Halifax, Nova Scotia
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Halifax,
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Jacksonville, Florida 32256
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Jacksonville, FL
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Orlando, Florida 32810
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Orlando, FL
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Saint Charles, Missouri 63304
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Saint Charles, MO
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Staten Island, New York 10305
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Staten Island, NY
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