Back to resultsA Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - the FORWARD-4 Study
Primary Purpose
Major Depressive Disorder
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
High Dose ALKS 5461
Low Dose ALKS 5461
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder focused on measuring Major Depressive Disorder, Depression, Alkermes, ALKS 5461, Samidorphan
Eligibility Criteria
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
Sites / Locations
- Alkermes Investigational Site
- Alkermes Investigational Site
- Alkermes Investigational Site
- Alkermes Investigational Site
- Alkermes Investigational Site
- Alkermes Investigational Site
- Alkermes Investigational Site
- Alkermes Investigational Site
- Alkermes Investigational Site
- Alkermes Investigational Site
- Alkermes Investigational Site
- Alkermes Investigational Site
- Alkermes Investigational Site
- Alkermes Investigational Site
- Alkermes, Investigational Site
- Alkermes Investigational Site
- Alkermes Investigational Site
- Alkermes Investigational Site
- Alkermes Investigational Site
- Alkermes Investigational Site
- Alkermes Investigational Site
- Alkermes Investigational Site
- Alkermes Investigational Site
- Alkermes Investigational Site
- Alkermes Investigational Site
- Alkermes Investigational Site
- Alkermes Investigational Site
- Alkermes Investigational Site
- Alkermes Investigational Site
- Alkermes Investigational Site
- Alkermes Investigational Site
- Alkermes Investigational Site
- Alkermes Investigational Site
- Alkermes Investigational Site
- Alkermes Investigational Site
- Alkermes Investigational Site
- Alkermes Investigational Site
- Alkermes Investigational Site
- Alkermes Investigational Site
- Alkermes Investigational Site
- Alkermes Investigational Site
- Alkermes Investigational Site
- Alkermes Investigational Site
- Alkermes Investigational Site
- Alkermes Investigational Site
- Alkermes Investigational Site
- Alkermes Investigational Site
- Alkermes Investigational Site
- Alkermes Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
High Dose
Low Dose
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Change From Baseline to Week 5 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score
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.
Secondary Outcome Measures
Proportion of Patients Who Exhibited Treatment Response (MADRS-10)
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).
Remission Rate
The proportion of subjects achieving remission, defined as a MADRS-10 score of </= 10 at the end of the efficacy period.
Number of Subjects With Adverse Events (AEs)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02158533
Brief Title
A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - the FORWARD-4 Study
Official Title
A Phase 3 Efficacy and Safety Study of ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder (the FORWARD-4 Study)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alkermes, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will evaluate the efficacy and safety of ALKS 5461.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Major Depressive Disorder, Depression, Alkermes, ALKS 5461, Samidorphan
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
385 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High Dose
Arm Type
Experimental
Arm Title
Low Dose
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
High Dose ALKS 5461
Other Intervention Name(s)
ALKS 5461
Intervention Description
Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant)
Intervention Type
Drug
Intervention Name(s)
Low Dose ALKS 5461
Other Intervention Name(s)
ALKS 5461
Intervention Description
Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant)
Primary Outcome Measure Information:
Title
Change From Baseline to Week 5 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score
Description
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.
Time Frame
Baseline and 5 weeks for each stage
Secondary Outcome Measure Information:
Title
Proportion of Patients Who Exhibited Treatment Response (MADRS-10)
Description
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).
Time Frame
Baseline and 5 weeks for each stage
Title
Remission Rate
Description
The proportion of subjects achieving remission, defined as a MADRS-10 score of </= 10 at the end of the efficacy period.
Time Frame
Baseline and 5 weeks for each stage
Title
Number of Subjects With Adverse Events (AEs)
Time Frame
5 weeks for Stage 1 and 6 weeks for Stage 2
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sanjeev Pathak, MD
Organizational Affiliation
Alkermes, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Alkermes Investigational Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35226
Country
United States
Facility Name
Alkermes Investigational Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Alkermes Investigational Site
City
Carson
State/Province
California
ZIP/Postal Code
90746
Country
United States
Facility Name
Alkermes Investigational Site
City
National City
State/Province
California
ZIP/Postal Code
91950
Country
United States
Facility Name
Alkermes Investigational Site
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Alkermes Investigational Site
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Facility Name
Alkermes Investigational Site
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Alkermes Investigational Site
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
Alkermes Investigational Site
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Facility Name
Alkermes Investigational Site
City
Norwich
State/Province
Connecticut
ZIP/Postal Code
06360
Country
United States
Facility Name
Alkermes Investigational Site
City
Coral Springs
State/Province
Florida
ZIP/Postal Code
33067
Country
United States
Facility Name
Alkermes Investigational Site
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
Alkermes Investigational Site
City
Lauderhill
State/Province
Florida
ZIP/Postal Code
33319
Country
United States
Facility Name
Alkermes Investigational Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Facility Name
Alkermes, Investigational Site
City
Alpharetta
State/Province
Georgia
ZIP/Postal Code
30005
Country
United States
Facility Name
Alkermes Investigational Site
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Facility Name
Alkermes Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
Alkermes Investigational Site
City
Joliet
State/Province
Illinois
ZIP/Postal Code
60435
Country
United States
Facility Name
Alkermes Investigational Site
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60076
Country
United States
Facility Name
Alkermes Investigational Site
City
Newburgh
State/Province
Indiana
ZIP/Postal Code
47630
Country
United States
Facility Name
Alkermes Investigational Site
City
Valparaiso
State/Province
Indiana
ZIP/Postal Code
46383
Country
United States
Facility Name
Alkermes Investigational Site
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42301
Country
United States
Facility Name
Alkermes Investigational Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21208
Country
United States
Facility Name
Alkermes Investigational Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21285
Country
United States
Facility Name
Alkermes Investigational Site
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
Alkermes Investigational Site
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11241
Country
United States
Facility Name
Alkermes Investigational Site
City
Mount Kisco
State/Province
New York
ZIP/Postal Code
10549
Country
United States
Facility Name
Alkermes Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10128
Country
United States
Facility Name
Alkermes Investigational Site
City
Staten Island
State/Province
New York
ZIP/Postal Code
10305
Country
United States
Facility Name
Alkermes Investigational Site
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Alkermes Investigational Site
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Facility Name
Alkermes Investigational Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Alkermes Investigational Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Alkermes Investigational Site
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18104
Country
United States
Facility Name
Alkermes Investigational Site
City
Media
State/Province
Pennsylvania
ZIP/Postal Code
19063
Country
United States
Facility Name
Alkermes Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Alkermes Investigational Site
City
Lincoln
State/Province
Rhode Island
ZIP/Postal Code
02865
Country
United States
Facility Name
Alkermes Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Alkermes Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77081
Country
United States
Facility Name
Alkermes Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Alkermes Investigational Site
City
Woodstock
State/Province
Vermont
ZIP/Postal Code
05091
Country
United States
Facility Name
Alkermes Investigational Site
City
Middleton
State/Province
Wisconsin
ZIP/Postal Code
53562
Country
United States
Facility Name
Alkermes Investigational Site
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4000
Country
Australia
Facility Name
Alkermes Investigational Site
City
Towong
State/Province
Queensland
ZIP/Postal Code
4066
Country
Australia
Facility Name
Alkermes Investigational Site
City
Frankston
State/Province
Victoria
ZIP/Postal Code
3199
Country
Australia
Facility Name
Alkermes Investigational Site
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Alkermes Investigational Site
City
Penticton
State/Province
British Columbia
Country
Canada
Facility Name
Alkermes Investigational Site
City
Gatineau
State/Province
Quebec
Country
Canada
Facility Name
Alkermes Investigational Site
City
Quebec
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - the FORWARD-4 Study
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