A Long-Term Safety Study of ALKS 5461

Completed · Phase 3

Conditions studied: Major Depressive Disorder

In brief

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

Key facts

Study ID

NCT02141399

Run by

Alkermes, Inc.

People needed

1485

Starts

2014-05-01

Expected to finish

2017-11-20

Last updated by the study team

2018-12-14

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Alkermes Investigational Site — Birmingham, Alabama, United States
• Alkermes Investigational Site — Tucson, Arizona, United States
• Alkermes Investigational Site — Little Rock, Arkansas, United States
• Alkermes Investigational Site — Bellflower, California, United States
• Alkermes Investigational Site — Beverly Hills, California, United States
• Alkermes Investigational Site — Carson, California, United States
• Alkermes Investigational Site — Garden Grove, California, United States
• Alkermes Investigational Site — Glendale, California, United States
• Alkermes Investigational Site — Los Alamitos, California, United States
• Alkermes Investigational Site — Los Angeles, California, United States
• Alkermes Investigational Site — National City, California, United States
• Alkermes Investigational Site — Oakland, California, United States
• Alkermes Investigational Site — Oceanside, California, United States
• Alkermes Investigational Site — Orange, California, United States
• Alkermes Investigational Site — Pico Rivera, California, United States
• Alkermes Investigational Site — Redlands, California, United States
• Alkermes Investigational Site — San Gabriel, California, United States
• Alkermes Investigational Site — Sherman Oaks, California, United States
• Alkermes Investigational Site — Temecula, California, United States
• Alkermes Investigational Site — Torrance, California, United States
• Alkermes Investigational Site — Upland, California, United States
• Alkermes Investigational Site — Colorado Springs, Colorado, United States
• Alkermes Investigational Site — Denver, Colorado, United States
• Alkermes Investigational Site — Hartford, Connecticut, United States
• Alkermes Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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