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

Completed · Phase 3

Conditions studied: Major Depressive Disorder

In brief

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

Key facts

Study ID

NCT02085135

Run by

Alkermes, Inc.

People needed

66

Starts

2014-02-01

Expected to finish

2014-09-01

Last updated by the study team

2019-08-14

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Alkermes Investigational Site — Jacksonville, Florida, United States
• Alkermes Investigational Site — Orlando, Florida, United States
• Alkermes Investigational Site — Atlanta, Georgia, United States
• Alkermes Investigational Site — Saint Charles, Missouri, United States
• Alkermes Investigational Site — Staten Island, New York, United States
• Alkermes Investigational Site — Dayton, Ohio, United States
• Alkermes Investigational Site — Allentown, Pennsylvania, United States
• Alkermes Investigational Site — Bellevue, Washington, United States
• Alkermes Investigational Site — Halifax, Nova Scotia, Canada

Full record on ClinicalTrials.gov

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