A Study to Evaluate ALKS 5461 in Subjects With Major Depressive Disorder (MDD)

Completed · Phase 2 · Has a placebo group

Conditions studied: Major Depressive Disorder

In brief

This study will evaluate the efficacy of ALKS 5461 when administered daily for 4 weeks to adults with Major Depressive Disorder (MDD) and inadequate response to antidepressant therapy.

Key facts

Study ID

NCT01500200

Run by

Alkermes, Inc.

People needed

142

Starts

2011-12-01

Expected to finish

2013-03-01

Last updated by the study team

2019-05-21

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosed with a major depressive episode (MDE)
• Body mass index less than or equal to 40 kg/m2
• Have been treated with an adequate dose of SSRI/SNRI during the current MDE for at least 8 weeks, with the same, adequate dose over the last 4 weeks that is expected to remain stable throughout the study
• History of inadequate response during the entire current MDE to 1 or 2 adequate antidepressant treatments, including current treatment
• Be otherwise physically healthy

You may not qualify if…

• Have an axis I diagnosis of delirium, dementia, amnestic or other cognitive disorder, schizophrenia or other psychotic disorder, bipolar I or II disorder, eating disorder, obsessive-compulsive disorder, panic disorder, acute stress disorder, or posttraumatic stress disorder
• Have a clinically significant current axis II diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal, or histrionic personality disorder
• Are experiencing hallucinations, delusions, or any psychotic symptomatology in the current MDE
• Receive new onset psychotherapy within 6 weeks of screening
• Use of opioid agonists (eg, codeine, oxycodone, morphine) within 14 days before screening
• Have received electroconvulsive therapy during the current MDE
• Have attempted suicide within the past 2 years
• Have a thyroid pathology
• Have a history of a seizure disorder or of neuroleptic malignant syndrome/serotonin syndrome
• Have a positive test for human immunodeficiency virus (HIV)
• Additional inclusion/exclusion criteria may apply

Where it is running

• Alkermes Investigational Site — Tucson, Arizona, United States
• Alkermes Investigational Site — Oceanside, California, United States
• Alkermes Investigational Site — Santa Ana, California, United States
• Alkermes Investigational Site — Torrance, California, United States
• Alkermes Investigational Site — Fort Myers, Florida, United States
• Alkermes Investigational Site — Lauderhill, Florida, United States
• Alkermes Investigational Site — Leesburg, Florida, United States
• Alkermes Investigational Site — North Miami, Florida, United States
• Alkermes Investigational Site — St. Petersburg, Florida, United States
• Alkermes Investigational Site — Atlanta, Georgia, United States
• Alkermes Investigational Site — Hoffman Estates, Illinois, United States
• Alkermes Investigational Site — Baltimore, Maryland, United States
• Alkermes Investigational Site — Boston, Massachusetts, United States
• Alkermes Investigational Site — Haverhill, Massachusetts, United States
• Alkermes Investigational Site — Berlin, New Jersey, United States
• Alkermes Investigational Site — Brooklyn, New York, United States
• Alkermes Investigational Site — New York, New York, United States
• Alkermes Investigational Site — Canton, Ohio, United States
• Alkermes Investigational Site — Dayton, Ohio, United States
• Alkermes Investigational Site — Oklahoma City, Oklahoma, United States
• Alkermes Investigational Site — Philadelphia, Pennsylvania, United States
• Alkermes Investigational Site — Charleston, South Carolina, United States
• Alkermes Investigational Site — Austin, Texas, United States
• Alkermes Investigational Site — Dallas, Texas, United States
• Alkermes Investigational Site — Houston, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.