A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - FORWARD-5 Study

Completed · Phase 3 · Has a placebo group

Conditions studied: Major Depressive Disorder

In brief

This study will evaluate the efficacy and safety of ALKS 5461.

Key facts

Study ID

NCT02218008

Run by

Alkermes, Inc.

People needed

407

Starts

2014-07-01

Expected to finish

2016-10-01

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…

• Have a BMI of 18.0 to 40.0 kg/m2, inclusive
• Agree to use an acceptable method of contraception for the duration of the study
• Have an MDD primary diagnosis
• Have no more than 2 inadequate responses to antidepressant therapy (ADT) in the current Major Depressive Episode (MDE)
• Additional criteria may apply

You may not qualify if…

• 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 one course of electroconvulsive treatment during their lifetime
• Have attempted suicide within the past 2 years
• Have a positive test for drugs of abuse
• Are pregnant, planning to become pregnant, or breastfeeding
• 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 60 days
• Additional criteria may apply

Where it is running

• Alkermes Investigational Site — Birmingham, Alabama, United States
• Alkermes Investigational Site — Colton, California, United States
• Alkermes Investigational Site — Garden Grove, California, United States
• Alkermes Investigational Site — Los Angeles, California, United States
• Alkermes Investigational Site — Oakland, California, United States
• Alkermes Investigational Site — Oceanside, California, United States
• Alkermes Investigational Site — Pico Rivera, California, United States
• Alkermes Investigational Site — San Gabriel, California, United States
• Alkermes Investigational Site — Colorado Springs, Colorado, United States
• Alkermes Investigational Site — Bradenton, Florida, United States
• Alkermes Investigational Site — Fort Myers, Florida, United States
• Alkermes Investigational Site — Melbourne, Florida, United States
• Alkermes Investigational Site — North Miami, Florida, United States
• Alkermes Investigational Site — Oakland Park, Florida, United States
• Alkermes Investigational Site — Winter Haven, Florida, United States
• Alkermes Investigational Site — Smyrna, Georgia, United States
• Alkermes Investigational Site — Hoffman Estates, Illinois, United States
• Alkermes Investigational Site — Flowood, Mississippi, United States
• Alkermes Investigational Site — Saint Charles, Missouri, United States
• Alkermes Investigational Site — St Louis, Missouri, United States
• Alkermes Investigational Site — Princeton, New Jersey, United States
• Alkermes Investigational Site — New York, New York, United States
• Alkermes Investigational Site — High Point, North Carolina, United States
• Alkermes Investigational Site — Canton, Ohio, United States
• Alkermes Investigational Site — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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