- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02158533
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
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
385
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
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Queensland
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Brisbane, Queensland, Australia, 4000
- Alkermes Investigational Site
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Towong, Queensland, Australia, 4066
- Alkermes Investigational Site
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Victoria
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Frankston, Victoria, Australia, 3199
- Alkermes Investigational Site
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Melbourne, Victoria, Australia, 3004
- Alkermes Investigational Site
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Quebec, Canada
- Alkermes Investigational Site
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British Columbia
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Penticton, British Columbia, Canada
- Alkermes Investigational Site
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Quebec
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Gatineau, Quebec, Canada
- Alkermes Investigational Site
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Alabama
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Birmingham, Alabama, United States, 35226
- Alkermes Investigational Site
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Arizona
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Tucson, Arizona, United States, 85712
- Alkermes Investigational Site
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California
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Carson, California, United States, 90746
- Alkermes Investigational Site
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National City, California, United States, 91950
- Alkermes Investigational Site
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Orange, California, United States, 92868
- Alkermes Investigational Site
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Sherman Oaks, California, United States, 91403
- Alkermes Investigational Site
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Torrance, California, United States, 90502
- Alkermes Investigational Site
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Upland, California, United States, 91786
- Alkermes Investigational Site
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Connecticut
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Hartford, Connecticut, United States, 06106
- Alkermes Investigational Site
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Norwich, Connecticut, United States, 06360
- Alkermes Investigational Site
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Florida
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Coral Springs, Florida, United States, 33067
- Alkermes Investigational Site
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Gainesville, Florida, United States, 32607
- Alkermes Investigational Site
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Lauderhill, Florida, United States, 33319
- Alkermes Investigational Site
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Orlando, Florida, United States, 32801
- Alkermes Investigational Site
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Georgia
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Alpharetta, Georgia, United States, 30005
- Alkermes, Investigational Site
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Decatur, Georgia, United States, 30030
- Alkermes Investigational Site
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Illinois
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Chicago, Illinois, United States, 60640
- Alkermes Investigational Site
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Joliet, Illinois, United States, 60435
- Alkermes Investigational Site
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Skokie, Illinois, United States, 60076
- Alkermes Investigational Site
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Indiana
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Newburgh, Indiana, United States, 47630
- Alkermes Investigational Site
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Valparaiso, Indiana, United States, 46383
- Alkermes Investigational Site
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Kentucky
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Owensboro, Kentucky, United States, 42301
- Alkermes Investigational Site
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Maryland
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Baltimore, Maryland, United States, 21208
- Alkermes Investigational Site
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Baltimore, Maryland, United States, 21285
- Alkermes Investigational Site
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New Jersey
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Berlin, New Jersey, United States, 08009
- Alkermes Investigational Site
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New York
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Brooklyn, New York, United States, 11241
- Alkermes Investigational Site
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Mount Kisco, New York, United States, 10549
- Alkermes Investigational Site
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New York, New York, United States, 10128
- Alkermes Investigational Site
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Staten Island, New York, United States, 10305
- Alkermes Investigational Site
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Ohio
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Canton, Ohio, United States, 44718
- Alkermes Investigational Site
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Dayton, Ohio, United States, 45417
- Alkermes Investigational Site
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73103
- Alkermes Investigational Site
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Oklahoma City, Oklahoma, United States, 73112
- Alkermes Investigational Site
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Pennsylvania
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Allentown, Pennsylvania, United States, 18104
- Alkermes Investigational Site
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Media, Pennsylvania, United States, 19063
- Alkermes Investigational Site
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Philadelphia, Pennsylvania, United States, 19107
- Alkermes Investigational Site
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Rhode Island
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Lincoln, Rhode Island, United States, 02865
- Alkermes Investigational Site
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Texas
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Austin, Texas, United States, 78731
- Alkermes Investigational Site
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Houston, Texas, United States, 77081
- Alkermes Investigational Site
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San Antonio, Texas, United States, 78229
- Alkermes Investigational Site
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Vermont
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Woodstock, Vermont, United States, 05091
- Alkermes Investigational Site
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Wisconsin
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Middleton, Wisconsin, United States, 53562
- Alkermes Investigational Site
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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 |
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Placebo Comparator: Placebo
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Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant)
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Experimental: High Dose
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Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant)
Other Names:
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Experimental: Low Dose
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Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant)
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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
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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.
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Baseline and 5 weeks for each stage
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Proportion of Patients Who Exhibited Treatment Response (MADRS-10)
Time Frame: Baseline and 5 weeks for each stage
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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).
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Baseline and 5 weeks for each stage
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Remission Rate
Time Frame: Baseline and 5 weeks for each stage
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The proportion of subjects achieving remission, defined as a MADRS-10 score of </= 10 at the end of the efficacy period.
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Baseline and 5 weeks for each stage
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Number of Subjects With Adverse Events (AEs)
Time Frame: 5 weeks for Stage 1 and 6 weeks for Stage 2
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5 weeks for Stage 1 and 6 weeks for Stage 2
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 6, 2014
First Posted (Estimate)
June 9, 2014
Study Record Updates
Last Update Posted (Actual)
August 14, 2019
Last Update Submitted That Met QC Criteria
August 2, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Pathologic Processes
- Mood Disorders
- Depression
- Depressive Disorder
- Disease
- Depressive Disorder, Major
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Opioid
- Narcotics
- Narcotic Antagonists
- Alcohol Deterrents
- Buprenorphine
- Naltrexone
Other Study ID 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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