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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 : Enrolling by invitation
First Posted : August 1, 2018
Last Update Posted : November 28, 2018
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)
Estimated Enrollment : 250 participants
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
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

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

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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

  Show 25 Study Locations
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     History of Changes
Other Study ID Numbers: ALK5461-218
First Posted: August 1, 2018    Key Record Dates
Last Update Posted: November 28, 2018
Last Verified: November 2018
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
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists
Alcohol Deterrents