A Study of ALKS 5461 for Treatment Refractory Major Depressive Disorder (MDD)

Completed · Phase 3 · Has a placebo group

Conditions studied: Major Depressive Disorder

In brief

This study will evaluate the efficacy, safety, and tolerability of adjunctive ALKS 5461 in adults who have treatment refractory MDD.

Key facts

Study ID

NCT03188185

Run by

Alkermes, Inc.

People needed

278

Starts

2017-06-12

Expected to finish

2020-03-05

Last updated by the study team

2021-04-08

Who can join

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

You may qualify if…

• Have a Major Depressive Disorder (MDD) primary diagnosis
• Have a body mass index (BMI) of 18.0 to </= 40.0 kg/m\^2
• Be willing and able to follow the study procedures and visits as outlined in the protocol (including agreeing not to enroll in any other clinical trials)
• Have inadequate responses to antidepressant therapy (ADT) in the current Major Depressive Episode (MDE)
• Additional criteria may apply

You may not qualify if…

• Has any finding that would compromise the safety of the subject or affect their ability to adhere to the protocol visit schedule or fulfill visit requirements
• Has any other significant medical condition (eg, neurological, psychiatric, or metabolic) or clinical symptom that could unduly risk the subject or affect the interpretation of study data
• Has any current primary diagnosis other than MDD, where primary diagnosis is defined as the primary source of current distress and functional impairment
• Has experienced hallucinations, delusions, or any psychotic symptoms in the current MDE
• Has been hospitalized for MDD within 3 months before screening
• Has used opioid agonists (eg, codeine, oxycodone, tramadol, morphine) or opioid antagonists (eg, naloxone, naltrexone) within 14 days prior to screening
• Has received electroconvulsive therapy treatment within the last 2 years or within the current MDE or failed a course of electroconvulsive treatment at any time
• Has a significant risk for suicide
• Has a positive breath alcohol test at screening
• Has a positive test for drugs of abuse at screening or visit 2
• Is pregnant, planning to become pregnant, or is breastfeeding during the study
• 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 Investigative Site — Upland, 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 Investigative 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

Full record on ClinicalTrials.gov

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