A Long Term Study of ALKS 5461 in the Treatment of Refractory Major Depressive Disorder (MDD)

Stopped early · Phase 3

Conditions studied: Refractory Major Depressive Disorder

In brief

This study will assess the long-term safety and tolerability of ALKS 5461 as an adjunctive treatment for refractory MDD.

Key facts

Study ID

NCT03610048

Run by

Alkermes, Inc.

People needed

175

Starts

2018-08-09

Expected to finish

2020-05-01

Last updated by the study team

2021-07-16

Who can join

Age: 18 and older, up to 72. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Completed study ALK5461-217
• Be willing to abide by the contraception requirements as outlined in the study protocol
• Be willing and able to follow the study procedures and visits as outlined in the protocol
• Additional criteria may apply

You may not qualify if…

• Pregnant, planning to become pregnant, or breastfeeding
• A positive urine drug test for drugs of abuse
• Poses a current suicide risk
• Additional criteria may apply

Where it is running

• Alkermes Investigational Site — Tucson, Arizona, United States
• Alkermes Investigational Site — Little Rock, Arkansas, United States
• Alkermes Investigational Site — Los Alamitos, California, United States
• Alkermes Investigational Site — Oceanside, California, United States
• Alkermes Investigational Site — Pico Rivera, California, United States
• Alkermes Investigational Site — Redlands, California, United States
• Alkermes Investigational Site — Santa Ana, California, United States
• Alkermes Investigational Site — Sherman Oaks, California, United States
• Alkermes Investigational Site — Temecula, California, United States
• Alkermes Investigational Site — Hollywood, Florida, United States
• Alkermes Investigational Site — Jacksonville, Florida, United States
• Alkermes Investigational Site — Lauderhill, Florida, United States
• Alkermes Investigational Site — Orlando, Florida, United States
• Alkermes Investigational Site — Palm Bay, Florida, United States
• Alkermes Investigational Site — Atlanta, Georgia, United States
• Alkermes Investigational Site — Decatur, Georgia, United States
• Alkermes Investigational Site — Pikesville, Maryland, United States
• Alkermes Investigational Site — O'Fallon, Missouri, United States
• Alkermes Investigational Site — Jamaica, New York, United States
• Alkermes Investigational Site — Mount Kisco, New York, United States
• Alkermes Investigational Site — Canton, Ohio, United States
• Alkermes Investigational Site — Cincinnati, Ohio, United States
• Alkermes Investigational Site — Oklahoma City, Oklahoma, United States
• Alkermes Investigational Site — Allentown, Pennsylvania, United States
• Alkermes Investigational Site — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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