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

June 29, 2021 updated by: Alkermes, Inc.

A Phase 3b Extension Study of Adjunctive ALKS 5461 in the Treatment of Refractory Major Depressive Disorder

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

175

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Frankston, Victoria, Australia, 3199
        • Alkermes Investigational Site
      • Noble Park, Victoria, Australia, 3174
        • Alkermes Investigational Site
      • Richmond, Victoria, Australia, 3121
        • Alkermes Investigational Site
  • Puerto Rico
      • San Juan, Puerto Rico, 00918
        • Alkermes Investigational Site
      • San Juan, Puerto Rico, 00926
        • Alkermes Investigational Site
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85712
        • Alkermes Investigational Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Alkermes Investigational Site
    • California
      • 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
        • Alkermes Investigational Site
    • Florida
      • 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
        • Alkermes Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30341
        • Alkermes Investigational Site
      • Decatur, Georgia, United States, 30030
        • Alkermes Investigational Site
    • Maryland
      • Pikesville, Maryland, United States, 21208
        • Alkermes Investigational Site
    • Missouri
      • O'Fallon, Missouri, United States, 63368
        • Alkermes Investigational Site
    • New York
      • Jamaica, New York, United States, 11432
        • Alkermes Investigational Site
      • Mount Kisco, New York, United States, 10549
        • Alkermes Investigational Site
    • Ohio
      • Canton, Ohio, United States, 44718
        • Alkermes Investigational Site
      • Cincinnati, Ohio, United States, 45215
        • Alkermes Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Alkermes Investigational Site
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18104
        • Alkermes Investigational Site
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Alkermes Investigational Site
    • Texas
      • Dallas, Texas, United States, 75390
        • Alkermes Investigational Site
      • DeSoto, Texas, United States, 75115
        • Alkermes Investigational Site
    • Vermont
      • Woodstock, Vermont, United States, 05091
        • Alkermes Investigational Site
    • Washington
      • Bellevue, Washington, United States, 98007
        • Alkermes Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 72 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: ALKS 5461
Sublingual tablets
Drug: ALKS 5461
samidorphan + buprenorphine administered sublingually

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Subjects With Treatment-emergent Adverse Events (TEAEs)
Time Frame: Up to 68 weeks
Number and percentage of subjects experiencing TEAEs
Up to 68 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alkermes, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 9, 2018

Primary Completion (ACTUAL)

May 1, 2020

Study Completion (ACTUAL)

May 1, 2020

Study Registration Dates

First Submitted

July 26, 2018

First Submitted That Met QC Criteria

July 26, 2018

First Posted (ACTUAL)

August 1, 2018

Study Record Updates

Last Update Posted (ACTUAL)

July 16, 2021

Last Update Submitted That Met QC Criteria

June 29, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALK5461-218

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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