A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - the FORWARD-4 Study

August 2, 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-4 Study)

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
385

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
      • Brisbane, Queensland, Australia, 4000
        • Alkermes Investigational Site
      • Towong, Queensland, Australia, 4066
        • Alkermes Investigational Site
    • Victoria
      • Frankston, Victoria, Australia, 3199
        • Alkermes Investigational Site
      • Melbourne, Victoria, Australia, 3004
        • Alkermes Investigational Site
  • Canada
      • Quebec, Canada
        • Alkermes Investigational Site
    • British Columbia
      • Penticton, British Columbia, Canada
        • Alkermes Investigational Site
    • Quebec
      • Gatineau, Quebec, Canada
        • Alkermes Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35226
        • Alkermes Investigational Site
    • Arizona
      • Tucson, Arizona, United States, 85712
        • Alkermes Investigational Site
    • California
      • Carson, California, United States, 90746
        • Alkermes Investigational Site
      • National City, California, United States, 91950
        • Alkermes Investigational Site
      • Orange, California, United States, 92868
        • Alkermes Investigational Site
      • Sherman Oaks, California, United States, 91403
        • Alkermes Investigational Site
      • Torrance, California, United States, 90502
        • Alkermes Investigational Site
      • Upland, California, United States, 91786
        • Alkermes Investigational Site
    • Connecticut
      • Hartford, Connecticut, United States, 06106
        • Alkermes Investigational Site
      • Norwich, Connecticut, United States, 06360
        • Alkermes Investigational Site
    • Florida
      • Coral Springs, Florida, United States, 33067
        • Alkermes Investigational Site
      • Gainesville, Florida, United States, 32607
        • Alkermes Investigational Site
      • Lauderhill, Florida, United States, 33319
        • Alkermes Investigational Site
      • Orlando, Florida, United States, 32801
        • Alkermes Investigational Site
    • Georgia
      • Alpharetta, Georgia, United States, 30005
        • Alkermes, Investigational Site
      • Decatur, Georgia, United States, 30030
        • Alkermes Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60640
        • Alkermes Investigational Site
      • Joliet, Illinois, United States, 60435
        • Alkermes Investigational Site
      • Skokie, Illinois, United States, 60076
        • Alkermes Investigational Site
    • Indiana
      • Newburgh, Indiana, United States, 47630
        • Alkermes Investigational Site
      • Valparaiso, Indiana, United States, 46383
        • Alkermes Investigational Site
    • Kentucky
      • Owensboro, Kentucky, United States, 42301
        • Alkermes Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21208
        • Alkermes Investigational Site
      • Baltimore, Maryland, United States, 21285
        • Alkermes Investigational Site
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • Alkermes Investigational Site
    • New York
      • Brooklyn, New York, United States, 11241
        • Alkermes Investigational Site
      • Mount Kisco, New York, United States, 10549
        • Alkermes Investigational Site
      • New York, New York, United States, 10128
        • Alkermes Investigational Site
      • Staten Island, New York, United States, 10305
        • Alkermes Investigational Site
    • Ohio
      • Canton, Ohio, United States, 44718
        • Alkermes Investigational Site
      • Dayton, Ohio, United States, 45417
        • Alkermes Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
        • Alkermes Investigational Site
      • Oklahoma City, Oklahoma, United States, 73112
        • 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
    • Rhode Island
      • Lincoln, Rhode Island, United States, 02865
        • Alkermes Investigational Site
    • Texas
      • Austin, Texas, United States, 78731
        • Alkermes Investigational Site
      • Houston, Texas, United States, 77081
        • Alkermes Investigational Site
      • San Antonio, Texas, United States, 78229
        • Alkermes Investigational Site
    • Vermont
      • Woodstock, Vermont, United States, 05091
        • Alkermes Investigational Site
    • Wisconsin
      • Middleton, Wisconsin, United States, 53562
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Drug: Placebo
Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant)
Experimental: High Dose
Drug: High Dose ALKS 5461
Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant)
Other Names:
  • ALKS 5461
Experimental: Low Dose
Drug: Low Dose ALKS 5461
Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant)
Other Names:
  • ALKS 5461

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline to Week 5 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score
Time Frame: Baseline and 5 weeks for each stage
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 5 weeks for each stage

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of Patients Who Exhibited Treatment Response (MADRS-10)
Time Frame: Baseline and 5 weeks for each stage
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 5). The MADRS-10 scale is a measure of the severity of MDD symptoms and includes the following 10 items: Apparent Sadness, Reported Sadness, Inner Tension, Reduced Sleep, Reduced Appetite, Concentration Difficulties, Lassitude, Inability to Feel, Pessimistic Thoughts, and Suicidal Thoughts. Scores range from 0 (no apparent symptoms) to 60 (most severe symptoms).
Baseline and 5 weeks for each stage
Remission Rate
Time Frame: Baseline and 5 weeks for each stage
The proportion of subjects achieving remission, defined as a MADRS-10 score of </= 10 at the end of the efficacy period.
Baseline and 5 weeks for each stage
Number of Subjects With Adverse Events (AEs)
Time Frame: 5 weeks for Stage 1 and 6 weeks for Stage 2
5 weeks for Stage 1 and 6 weeks for Stage 2

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Alkermes, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 5, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 6, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 9, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 14, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ALK5461-205

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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