A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - the FORWARD-3 Study

May 31, 2019 updated by: Alkermes, Inc.

A Phase 3 Efficacy and Safety Study of ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder (the FORWARD-3 Study)

This study will evaluate the efficacy and safety of ALKS 5461.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

447

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

  • 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 Tarnovo, Bulgaria, 5000
        • Alkermes Investigational Site
      • Vratza, Bulgaria, 3000
        • Alkermes Investigational Site
  • United States
    • 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
      • Glendale, California, United States, 91206
        • Alkermes Investigational Site
      • Los Alamitos, California, United States, 90720
        • Alkermes Investigational Site
      • Orange, California, United States, 92868
        • Alkermes Investigational Site
      • Redlands, California, United States, 92374
        • Alkermes Investigational Site
      • Temecula, California, United States, 92591
        • Alkermes Investigational Site
    • District of Columbia
      • Washington, District of Columbia, United States, 20016
        • Alkermes Investigational Site
    • Florida
      • 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
      • Leesburg, Florida, United States, 34748
        • Alkermes Investigational Site
      • Maitland, Florida, United States, 32751
        • Alkermes Investigational Site
      • Tampa, Florida, United States, 33613
        • Alkermes Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30331
        • Alkermes Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60634
        • Alkermes Investigational Site
      • Oak Brook, Illinois, United States, 60523
        • Alkermes Investigational Site
      • Vernon Hills, Illinois, United States, 60061
        • Alkermes Investigational Site
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Alkermes Investigational Site
      • Lafayette, Indiana, United States, 47905
        • Alkermes Investigational Site
    • Kentucky
      • Edgewood, Kentucky, United States, 41017
        • Alkermes Investigational Site
    • Maryland
      • Washington DC, Maryland, United States, 20016
        • Alkermes Investigational
    • Massachusetts
      • Brockton, Massachusetts, United States, 02301
        • Alkermes Investigational Site
      • Watertown, Massachusetts, United States, 02472
        • Alkermes Investigational Site
    • Missouri
      • Kansas City, Missouri, United States, 64114
        • Alkermes Investigational Site
      • O'Fallon, Missouri, United States, 63368
        • Alkermes Investigational Site
      • Saint Louis, Missouri, United States, 63109
        • Alkermes Investigational Site
    • New Jersey
      • Cherry Hill, New Jersey, United States, 08002
        • Alkermes Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Alkermes Investigational Site
    • New York
      • Jamaica, New York, United States, 11432
        • Alkermes Investigational Site
      • New York, New York, United States, 10023
        • Alkermes Investigational Site
      • Staten Island, New York, United States, 10312
        • Alkermes Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Alkermes Investigational Site
    • Ohio
      • Beachwood, Ohio, United States, 44122
        • Alkermes Investigational Site
      • Cincinnati, Ohio, United States, 45215
        • Alkermes Investigational Site
      • Cincinnati, Ohio, United States, 45227
        • Alkermes Investigational Site
      • Mason, Ohio, United States, 45040
        • Alkermes Investigational Site
      • Middleburg Heights, Ohio, United States, 44130
        • Alkermes Investigational Site
    • Oregon
      • Portland, Oregon, United States, 97210
        • Alkermes Investigational Site
      • Salem, Oregon, United States, 97301
        • Alkermes Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Alkermes Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States, 29407
        • Alkermes Investigational Site
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Alkermes Investigational Site
    • Texas
      • Dallas, Texas, United States, 75231
        • Alkermes Investigational Site
      • Dallas, Texas, United States, 75309
        • Alkermes Investigational Site
      • Houston, Texas, United States, 77098
        • Alkermes Investigational Site
      • Sugar Land, Texas, United States, 77478
        • Alkermes Investigational Site
    • Washington
      • Bellevue, Washington, United States, 98007
        • Alkermes Investigational Site
    • Wisconsin
      • 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:

  • Have a Body Mass Index (BMI) of 18.0 to 40.0 kg/m2, inclusive
  • Agree to use an acceptable method of contraception for the duration of the study
  • Have a Major Depressive Disorder (MDD) primary diagnosis
  • Have no more than 2 inadequate responses to antidepressant therapy (ADT) in the current Major Depressive Episode (MDE)
  • Additional criteria may apply

Exclusion Criteria:

  • 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 one course of electroconvulsive treatment during lifetime
  • Have attempted suicide within the past 2 years
  • Have a positive test for drugs of abuse
  • Are pregnant, planning to become pregnant, or breastfeeding
  • 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 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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant)
Experimental: ALKS 5461
Drug: ALKS 5461
Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline to End of Treatment (Week 6) in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score
Time Frame: Baseline and week 6
The MADRS-10 scale is a clinician-administered questionnaire comprised of 10 items used to measure the severity of MDD symptoms. Scores range from 0 (no apparent symptoms) to 60 (most severe symptoms). Individual questionnaire items include: Apparent Sadness, Reported Sadness, Inner Tension, Reduced Sleep, Reduced Appetite, Concentration Difficulties, Lassitude, Inability to Feel, Pessimistic Thoughts, and Suicidal Thoughts.
Baseline and week 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Patients Who Exhibited Treatment Response (MADRS-10)
Time Frame: 6 weeks
The proportion of subjects demonstrating MADRS-10 treatment response, defined as a ≥ 50% reduction in MADRS-10 score from baseline to the end of the efficacy period (week 6).
6 weeks
Remission Rate
Time Frame: 6 weeks
The proportion of subjects achieving remission, defined as a MADRS-10 score of ≤ 10 at the end of the efficacy period.
6 weeks
Number of Subjects With Adverse Events (AEs)
Time Frame: 6 weeks
6 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

May 1, 2014

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

June 5, 2014

First Submitted That Met QC Criteria

June 5, 2014

First Posted (Estimate)

June 9, 2014

Study Record Updates

Last Update Posted (Actual)

June 25, 2019

Last Update Submitted That Met QC Criteria

May 31, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALK5461-206

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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