A Long-Term Safety Study of ALKS 5461

November 21, 2018 updated by: Alkermes, Inc.

A Phase 3 Multicenter Study of the Long-Term Safety and Tolerability of ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder in Adults Who Have an Inadequate Response to Antidepressant Therapy (the FORWARD-2 Study)

This is a 52-week open-label study to evaluate the safety and tolerability of ALKS 5461.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1485

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
    • Queensland
      • Towong, Queensland, Australia, 4066
        • Alkermes Investigational Site
    • Victoria
      • Frankston, Victoria, Australia, 3199
        • Alkermes Investigational Site
      • Melbourne, Victoria, Australia, 3004
        • Alkermes Investigational Site
  • Bulgaria
      • Bourgas, Bulgaria, 8001
        • Alkermes Investigational Site
      • Kazanlak, Bulgaria, 6100
        • Alkermes Investigational Site
      • Sofia, Bulgaria, 1113
        • Alkermes Investigational Site
      • Sofia, Bulgaria, 1431
        • Alkermes Investigational Site
      • Sofia, Bulgaria, 1632
        • Alkermes Investigational Site
      • Varna, Bulgaria, 9020
        • Alkermes Investigational Site
      • Veliko Turnovo, Bulgaria, 5000
        • Alkermes Investigational Site
      • Vratza, Bulgaria, 3000
        • Alkermes Investigational Site
  • Canada
      • Quebec, Canada, G3K 2P8
        • Alkermes Investigational Site
    • British Columbia
      • Penticton, British Columbia, Canada, V2A 4M4
        • Alkermes Investigational Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3S 1L8
        • Alkermes Investigational Site
    • Quebec
      • Gatineau, Quebec, Canada, J8T 8JL
        • Alkermes Investigational Site
  • Germany
      • Achim, Germany, 28832
        • Alkermes Investigational Site
      • Berlin, Germany, 10245
        • Alkermes Investigational Site
      • Berlin, Germany, 10629
        • Alkermes Investigational Site
      • Berlin, Germany, 10365
        • Alkermes Investigational Site
      • Ellwangen, Germany, 73479
        • Alkermes Investigational Site
      • Freiburg, Germany, 79104
        • Alkermes Investigational Site
      • Hannover, Germany, 30159
        • Alkermes Investigational Site
      • Mainz, Germany, 55131
        • Alkermes Investigational Site
      • Schwerin, Germany, 19053
        • Alkermes Investigational Site
      • Stralsund, Germany, 18439
        • Alkermes Investigational Site
    • Brandenburg
      • Oranienburg, Brandenburg, Germany, 16515
        • Alkermes Investigational Site
  • Hungary
      • Budapest, Hungary, 1053
        • Alkermes Investigational Site
      • Budapest, Hungary, 1135
        • Alkermes Investigational Site
      • Budapest, Hungary, 1137
        • Alkermes Investigational Site
  • Poland
      • Bialystok, Poland, 15-879
        • Alkermes Investigational Site
      • Gdansk, Poland, 80-546
        • Alkermes Investigational Site
      • Gdansk, Poland, 80-438
        • Alkermes Investigational Site
      • Gorlice, Poland, 38-300
        • Alkermes Investigational Site
  • Puerto Rico
      • San Juan, Puerto Rico, 00918
        • Alkermes Investigational Site
      • San Juan, Puerto Rico, 00926
        • Alkermes Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Alkermes Investigational Site
      • Birmingham, Alabama, United States, 35226
        • Alkermes Investigational Site
    • Arizona
      • Tucson, Arizona, United States, 85712
        • Alkermes Investigational Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Alkermes Investigational Site
    • California
      • Bellflower, California, United States, 90706
        • Alkermes Investigational Site
      • Beverly Hills, California, United States, 90210
        • Alkermes Investigational Site
      • Carson, California, United States, 90746
        • Alkermes Investigational Site
      • Garden Grove, California, United States, 92845
        • Alkermes Investigational Site
      • Glendale, California, United States, 91206
        • Alkermes Investigational Site
      • Los Alamitos, California, United States, 90720
        • Alkermes Investigational Site
      • Los Angeles, California, United States, 90024
        • Alkermes Investigational Site
      • National City, California, United States, 91950
        • Alkermes Investigational Site
      • Oakland, California, United States, 94612
        • Alkermes Investigational Site
      • Oceanside, California, United States, 92056
        • Alkermes Investigational Site
      • Orange, California, United States, 92868
        • Alkermes Investigational Site
      • Pico Rivera, California, United States, 90660
        • Alkermes Investigational Site
      • Redlands, California, United States, 92374
        • Alkermes Investigational Site
      • San Gabriel, California, United States, 91776
        • Alkermes Investigational Site
      • Sherman Oaks, California, United States, 91403
        • Alkermes Investigational Site
      • Temecula, California, United States, 92591
        • Alkermes Investigational Site
      • Torrance, California, United States, 90502
        • Alkermes Investigational Site
      • Upland, California, United States, 91786
        • Alkermes Investigational Site
    • Colorado
      • Colorado Springs, Colorado, United States, 80910
        • Alkermes Investigational Site
      • Denver, Colorado, United States, 80209
        • Alkermes Investigational Site
    • Connecticut
      • Hartford, Connecticut, United States, 06106
        • Alkermes Investigational Site
      • Norwich, Connecticut, United States, 06360
        • Alkermes Investigational Site
    • Florida
      • Bradenton, Florida, United States, 34201
        • Alkermes Investigational Site
      • Coral Springs, Florida, United States, 33067
        • Alkermes Investigational Site
      • Fort Myers, Florida, United States, 33912
        • Alkermes Investigational Site
      • Gainesville, Florida, United States, 32607
        • Alkermes Investigational Site
      • Hallandale Beach, Florida, United States, 33009
        • Alkermes Investigational Site
      • Hialeah, Florida, United States, 33016
        • Alkermes Investigational Site
      • Jacksonville, Florida, United States, 32256
        • Alkermes Investigational Site
      • Lauderhill, Florida, United States, 33319
        • Alkermes Investigational Site
      • Maitland, Florida, United States, 32751
        • Alkermes Investigational Site
      • Melbourne, Florida, United States, 32901
        • Alkermes Investigational Site
      • North Miami, Florida, United States, 33161
        • Alkermes Investigational Site
      • Oakland Park, Florida, United States, 33334
        • Alkermes Investigational Site
      • Orlando, Florida, United States, 32801
        • Alkermes Investigational Site
      • Tampa, Florida, United States, 33613
        • Alkermes Investigational Site
      • The Villages, Florida, United States, 32162
        • Alkermes Investigational Site
      • West Palm Beach, Florida, United States, 33407
        • Alkermes Investigational Site
      • Winter Haven, Florida, United States, 33880
        • Alkermes Investigational Site
    • Georgia
      • Alpharetta, Georgia, United States, 30005
        • Alkermes Investigational Site
      • Atlanta, Georgia, United States, 30308
        • Alkermes Investigational Site
      • Decatur, Georgia, United States, 30030
        • Alkermes Investigational Site
      • Smyrna, Georgia, United States, 30080
        • Alkermes Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60640
        • Alkermes Investigational Site
      • Chicago, Illinois, United States, 60634
        • Alkermes Investigational Site
      • Deerfield, Illinois, United States, 60015
        • Alkermes Investigational Site
      • Hoffman Estates, Illinois, United States, 60169
        • Alkermes Investigational Site
      • Joliet, Illinois, United States, 60435
        • Alkermes Investigational Site
      • Oak Brook, Illinois, United States, 60523
        • Alkermes Investigational Site
      • Skokie, Illinois, United States, 60076
        • Alkermes Investigational Site
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Alkermes Investigational Site
      • Lafayette, Indiana, United States, 47905
        • Alkermes Investigational Site
      • Newburgh, Indiana, United States, 47630
        • Alkermes Investigational Site
      • Valparaiso, Indiana, United States, 46383
        • Alkermes Investigational Site
    • Kentucky
      • Edgewood, Kentucky, United States, 41017
        • Alkermes Investigational Site
      • Owensboro, Kentucky, United States, 42301
        • Alkermes Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21208
        • Alkermes Investigational Site
      • Baltimore, Maryland, United States, 21204
        • Alkermes Investigational Site
      • Washington D.C., Maryland, United States, 20016
        • Alkermes Investigational Site
    • Massachusetts
      • Belmont, Massachusetts, United States, 02478
        • Alkermes Investigational Site
      • Brockton, Massachusetts, United States, 02301
        • Alkermes Investigational Site
      • Watertown, Massachusetts, United States, 02472
        • Alkermes Investigational Site
      • Worcester, Massachusetts, United States, 01655
        • Alkermes Investigational Site
    • Mississippi
      • Flowood, Mississippi, United States, 39232
        • Alkermes Investigational Site
    • Missouri
      • O'Fallon, Missouri, United States, 63368
        • Alkermes Investigational Site
      • Saint Charles, Missouri, United States, 63304
        • Alkermes Investigational Site
      • Saint Louis, Missouri, United States, 63141
        • Alkermes Investigational Site
      • Saint Louis, Missouri, United States, 63109
        • Alkermes Investigational Site
    • New Jersey
      • Berlin, New Jersey, United States, 80091
        • Alkermes Investigational Site
      • Cherry Hill, New Jersey, United States, 08002
        • Alkermes Investigational Site
      • Princeton, New Jersey, United States, 08540
        • Alkermes Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Alkermes Investigational Site
    • New York
      • Brooklyn, New York, United States, 11241
        • Alkermes Investigational Site
      • Jamaica, New York, United States, 11432
        • Alkermes Investigational Site
      • Mount Kisco, New York, United States, 10549
        • Alkermes Investigational Site
      • New York, New York, United States, 10168
        • Alkermes Investigational Site
      • New York, New York, United States, 10029
        • Alkermes Investigational Site
      • New York, New York, United States, 10128
        • Alkermes Investigational Site
      • New York, New York, United States, 10019
        • Alkermes Investigational Site
      • New York, New York, United States, 10023
        • Alkermes Investigational Site
      • Staten Island, New York, United States, 10312
        • Alkermes Investigational Site
      • Staten Island, New York, United States, 10305
        • Alkermes Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Alkermes Investigational Site
      • High Point, North Carolina, United States, 27265
        • Alkermes Investigational Site
    • Ohio
      • Beachwood, Ohio, United States, 44122
        • Alkermes Investigational Site
      • Canton, Ohio, United States, 44718
        • Alkermes Investigational Site
      • Cincinnati, Ohio, United States, 45215
        • Alkermes Investigational Site
      • Cincinnati, Ohio, United States, 45227
        • Alkermes Investigational Site
      • Dayton, Ohio, United States, 45417
        • Alkermes Investigational Site
      • Mason, Ohio, United States, 45040
        • Alkermes Investigational Site
      • Middleburg Heights, Ohio, United States, 44130
        • Alkermes Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
        • Alkermes Investigational Site
      • Oklahoma City, Oklahoma, United States, 73112
        • Alkermes Investigational Site
    • Oregon
      • Portland, Oregon, United States, 97214
        • Alkermes Investigational Site
      • Portland, Oregon, United States, 97210
        • Alkermes Investigational Site
      • Salem, Oregon, United States, 97301
        • Alkermes Investigational Site
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18104
        • Alkermes Investigational Site
      • Media, Pennsylvania, United States, 19063
        • Alkermes Investigational Site
      • Philadelphia, Pennsylvania, United States, 19107
        • Alkermes Investigational Site
      • Philadelphia, Pennsylvania, United States, 19104
        • Alkermes Investigational Site
    • Rhode Island
      • Lincoln, Rhode Island, United States, 02865
        • Alkermes Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States, 29407
        • Alkermes Investigational Site
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Alkermes Investigational Site
    • Texas
      • Austin, Texas, United States, 78731
        • Alkermes Investigational Site
      • Dallas, Texas, United States, 75231
        • Alkermes Investigational Site
      • Dallas, Texas, United States, 75390
        • Alkermes Investigational Site
      • DeSoto, Texas, United States, 75115
        • Alkermes Investigational Site
      • Houston, Texas, United States, 77081
        • Alkermes Investigational Site
      • Houston, Texas, United States, 77098
        • Alkermes Investigational Site
      • San Antonio, Texas, United States, 78229
        • Alkermes Investigational Site
      • Sugar Land, Texas, United States, 77478
        • Alkermes Investigational Site
      • Wichita Falls, Texas, United States, 76309
        • Alkermes Investigational Site
    • Utah
      • Clinton, Utah, United States, 84015
        • Alkermes Investigational Site
    • Vermont
      • Woodstock, Vermont, United States, 05091
        • Alkermes Investigational Site
    • Washington
      • Bellevue, Washington, United States, 98007
        • Alkermes Investigational Site
      • Seattle, Washington, United States, 98104
        • Alkermes Investigational Site
      • Spokane, Washington, United States, 99204
        • Alkermes Investigational Site
    • Wisconsin
      • Middleton, Wisconsin, United States, 53562
        • Alkermes Investigational Site
      • Waukesha, Wisconsin, United States, 53188
        • 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 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Agree to use an approved method of contraception for the duration of the study
  • Have the potential to safely benefit from the administration of ALKS 5461
  • Have a diagnosis of major depressive disorder (MDD)
  • Additional criteria may apply

Exclusion Criteria:

  • Have a positive test for drugs of abuse
  • Currently pregnant or breastfeeding
  • Have a current primary Axis-I disorder other than MDD
  • Have used opioid agonists (eg, codeine, oxycodone, tramadol, morphine) or opioid antagonists (eg, naloxone, naltrexone) within 14 days
  • Have received electroconvulsive therapy treatment within the last 2 years, or received more than 1 course of electroconvulsive treatment during their lifetime
  • Have attempted suicide within the past 2 years
  • Have a history of intolerance, allergy, or hypersensitivity to buprenorphine or opioid antagonists (eg, naltrexone, naloxone)
  • Have had a significant blood loss or blood donation within the past 60 days
  • 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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ALKS 5461
Drug: ALKS 5461
Sublingual tablet, taken daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of Adverse Events (AEs)
Time Frame: Up to 56 weeks
Up to 56 weeks

Collaborators and Investigators

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

Sponsor

Alkermes, Inc.

Investigators

  • Study Director: Sanjeev Pathak, MD, 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)

May 1, 2014

Primary Completion (Actual)

November 20, 2017

Study Completion (Actual)

November 20, 2017

Study Registration Dates

First Submitted

May 15, 2014

First Submitted That Met QC Criteria

May 15, 2014

First Posted (Estimate)

May 19, 2014

Study Record Updates

Last Update Posted (Actual)

December 14, 2018

Last Update Submitted That Met QC Criteria

November 21, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALK5461-208

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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