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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03610048
Recruitment Status : Terminated (Sponsor Decision)
First Posted : August 1, 2018
Last Update Posted : May 19, 2020
Information provided by (Responsible Party):
Alkermes, Inc.

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

Condition or disease Intervention/treatment Phase
Refractory Major Depressive Disorder Drug: ALKS 5461 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 175 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Open-label
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3b Extension Study of Adjunctive ALKS 5461 in the Treatment of Refractory Major Depressive Disorder
Actual Study Start Date : August 9, 2018
Actual Primary Completion Date : May 1, 2020
Actual Study Completion Date : May 1, 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: ALKS 5461
Sublingual tablets
Drug: ALKS 5461
samidorphan + buprenorphine administered sublingually

Primary Outcome Measures :
  1. Number of Subjects with Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Up to 68 weeks ]
    Number and percentage of subjects experiencing TEAEs

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 72 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03610048

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United States, Arizona
Alkermes Investigational Site
Tucson, Arizona, United States, 85712
United States, Arkansas
Alkermes Investigational Site
Little Rock, Arkansas, United States, 72211
United States, California
Alkermes Investigational Site
Los Alamitos, California, United States, 90720
Alkermes Investigational Site
Oceanside, California, United States, 92054
Alkermes Investigational Site
Pico Rivera, California, United States, 90660
Alkermes Investigational Site
Redlands, California, United States, 92374
Alkermes Investigational Site
Santa Ana, California, United States, 92705
Alkermes Investigational Site
Sherman Oaks, California, United States, 91403
Alkermes Investigational Site
Temecula, California, United States, 92591
United States, Florida
Alkermes Investigational Site
Hollywood, Florida, United States, 33024
Alkermes Investigational Site
Jacksonville, Florida, United States, 32256
Alkermes Investigational Site
Lauderhill, Florida, United States, 33319
Alkermes Investigational Site
Orlando, Florida, United States, 32801
Alkermes Investigational Site
Palm Bay, Florida, United States, 32905
United States, Georgia
Alkermes Investigational Site
Atlanta, Georgia, United States, 30341
Alkermes Investigational Site
Decatur, Georgia, United States, 30030
United States, Maryland
Alkermes Investigational Site
Pikesville, Maryland, United States, 21208
United States, Missouri
Alkermes Investigational Site
O'Fallon, Missouri, United States, 63368
United States, New York
Alkermes Investigational Site
Jamaica, New York, United States, 11432
Alkermes Investigational Site
Mount Kisco, New York, United States, 10549
United States, Ohio
Alkermes Investigational Site
Canton, Ohio, United States, 44718
Alkermes Investigational Site
Cincinnati, Ohio, United States, 45215
United States, Oklahoma
Alkermes Investigational Site
Oklahoma City, Oklahoma, United States, 73112
United States, Pennsylvania
Alkermes Investigational Site
Allentown, Pennsylvania, United States, 18104
United States, Tennessee
Alkermes Investigational Site
Memphis, Tennessee, United States, 38119
United States, Texas
Alkermes Investigational Site
Dallas, Texas, United States, 75390
Alkermes Investigational Site
DeSoto, Texas, United States, 75115
United States, Vermont
Alkermes Investigational Site
Woodstock, Vermont, United States, 05091
United States, Washington
Alkermes Investigational Site
Bellevue, Washington, United States, 98007
Australia, Victoria
Alkermes Investigational Site
Frankston, Victoria, Australia, 3199
Alkermes Investigational Site
Noble Park, Victoria, Australia, 3174
Alkermes Investigational Site
Richmond, Victoria, Australia, 3121
Puerto Rico
Alkermes Investigational Site
San Juan, Puerto Rico, 00918
Alkermes Investigational Site
San Juan, Puerto Rico, 00926
Sponsors and Collaborators
Alkermes, Inc.
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Study Director: Alkermes Medical Director Alkermes, Inc.
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Responsible Party: Alkermes, Inc. Identifier: NCT03610048    
Other Study ID Numbers: ALK5461-218
First Posted: August 1, 2018    Key Record Dates
Last Update Posted: May 19, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alkermes, Inc.:
Major depressive disorder
ALKS 5461
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms