A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - the FORWARD-3 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

NCT02158546

Run by

Alkermes, Inc.

People needed

447

Starts

2014-05-01

Expected to finish

2015-12-01

Last updated by the study team

2019-06-25

Who can join

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

You may qualify if…

• Have a Body Mass Index (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 a Major Depressive Disorder (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 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 — Bellflower, California, United States
• Alkermes Investigational Site — Beverly Hills, California, United States
• Alkermes Investigational Site — Glendale, California, United States
• Alkermes Investigational Site — Los Alamitos, California, United States
• Alkermes Investigational Site — Orange, California, United States
• Alkermes Investigational Site — Redlands, California, United States
• Alkermes Investigational Site — Temecula, California, United States
• Alkermes Investigational Site — Washington D.C., District of Columbia, United States
• Alkermes Investigational Site — Hallandale, Florida, United States
• Alkermes Investigational Site — Hialeah, Florida, United States
• Alkermes Investigational Site — Jacksonville, Florida, United States
• Alkermes Investigational Site — Leesburg, Florida, United States
• Alkermes Investigational Site — Maitland, Florida, United States
• Alkermes Investigational Site — Tampa, Florida, United States
• Alkermes Investigational Site — Atlanta, Georgia, United States
• Alkermes Investigational Site — Chicago, Illinois, United States
• Alkermes Investigational Site — Oak Brook, Illinois, United States
• Alkermes Investigational Site — Vernon Hills, Illinois, United States
• Alkermes Investigational Site — Indianapolis, Indiana, United States
• Alkermes Investigational Site — Lafayette, Indiana, United States
• Alkermes Investigational Site — Edgewood, Kentucky, United States
• Alkermes Investigational — Washington DC, Maryland, United States
• Alkermes Investigational Site — Brockton, Massachusetts, United States
• Alkermes Investigational Site — Watertown, Massachusetts, United States
• Alkermes Investigational Site — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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