A Long-Term Safety Study of ALKS 5461



Status:Completed
Conditions:Depression, Depression, Major Depression Disorder (MDD)
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 70
Updated:12/16/2018
Start Date:May 2014
End Date:November 20, 2017

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A Phase 3 Multicenter Study of the Long-Term Safety and Tolerability of ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder in Adults Who Have an Inadequate Response to Antidepressant Therapy (the FORWARD-2 Study)

This is a 52-week open-label study to evaluate the safety and tolerability of ALKS 5461.


Inclusion Criteria:

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

- Have the potential to safely benefit from the administration of ALKS 5461

- Have a diagnosis of major depressive disorder (MDD)

- Additional criteria may apply

Exclusion Criteria:

- Have a positive test for drugs of abuse

- Currently pregnant or breastfeeding

- 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 1 course of electroconvulsive treatment during their lifetime

- 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 within the past 60 days

- Additional criteria may apply
We found this trial at
125
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San Antonio, Texas
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Albuquerque, New Mexico
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Charlotte, North Carolina 28204
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Chicago, Illinois 60611
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Newburgh, Indiana 47630
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