Major Depressive DisorderPhase 3NCT02141399
A Long-Term Safety Study of ALKS 5461
A Phase 3 study testing ALKS 5461 in people with Major Depressive Disorder, run by Alkermes, Inc. at 158 sites in 8 countries.
Trial summary
This is a 52-week open-label study to evaluate the safety and tolerability of ALKS 5461. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- ALKS 5461
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,485 participants
- Where
- 158 sitesin 8 countries
- Study dates
- May 2014to 20 Nov 2017
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
158 sites in 8 countries.
158 sites in 8 countries
United States123 sites
Alkermes Investigational Site
Albuquerque, New Mexico, 87109
Alkermes Investigational Site
Allentown, Pennsylvania, 18104
Alkermes Investigational Site
Alpharetta, Georgia, 30005
Alkermes Investigational Site
Atlanta, Georgia, 30308
Alkermes Investigational Site
Austin, Texas, 78731
Alkermes Investigational Site
Baltimore, Maryland, 21204
Alkermes Investigational Site
Baltimore, Maryland, 21208
Alkermes Investigational Site
Beachwood, Ohio, 44122
Alkermes Investigational Site
Bellevue, Washington, 98007
Alkermes Investigational Site
Bellflower, California, 90706
Alkermes Investigational Site
Belmont, Massachusetts, 02478
Alkermes Investigational Site
Berlin, New Jersey, 80091
Alkermes Investigational Site
Beverly Hills, California, 90210
Alkermes Investigational Site
Birmingham, Alabama, 35226
Alkermes Investigational Site
Birmingham, Alabama, 35294
Alkermes Investigational Site
Bradenton, Florida, 34201
Alkermes Investigational Site
Brockton, Massachusetts, 02301
Alkermes Investigational Site
Brooklyn, New York, 11241
Alkermes Investigational Site
Canton, Ohio, 44718
Alkermes Investigational Site
Carson, California, 90746
Alkermes Investigational Site
Charleston, South Carolina, 29407
Alkermes Investigational Site
Charlotte, North Carolina, 28204
Alkermes Investigational Site
Cherry Hill, New Jersey, 08002
Alkermes Investigational Site
Chicago, Illinois, 60634
Alkermes Investigational Site
Chicago, Illinois, 60640
Alkermes Investigational Site
Cincinnati, Ohio, 45215
Alkermes Investigational Site
Cincinnati, Ohio, 45227
Alkermes Investigational Site
Clinton, Utah, 84015
Alkermes Investigational Site
Colorado Springs, Colorado, 80910
Alkermes Investigational Site
Coral Springs, Florida, 33067
Alkermes Investigational Site
Dallas, Texas, 75231
Alkermes Investigational Site
Dallas, Texas, 75390
Alkermes Investigational Site
Dayton, Ohio, 45417
Alkermes Investigational Site
Decatur, Georgia, 30030
Alkermes Investigational Site
Deerfield, Illinois, 60015
Alkermes Investigational Site
Denver, Colorado, 80209
Alkermes Investigational Site
DeSoto, Texas, 75115
Alkermes Investigational Site
Edgewood, Kentucky, 41017
Alkermes Investigational Site
Flowood, Mississippi, 39232
Alkermes Investigational Site
Fort Myers, Florida, 33912
Alkermes Investigational Site
Gainesville, Florida, 32607
Alkermes Investigational Site
Garden Grove, California, 92845
Alkermes Investigational Site
Glendale, California, 91206
Alkermes Investigational Site
Hallandale, Florida, 33009
Alkermes Investigational Site
Hartford, Connecticut, 06106
Alkermes Investigational Site
Hialeah, Florida, 33016
Alkermes Investigational Site
High Point, North Carolina, 27265
Alkermes Investigational Site
Hoffman Estates, Illinois, 60169
Alkermes Investigational Site
Houston, Texas, 77081
Alkermes Investigational Site
Houston, Texas, 77098
Alkermes Investigational Site
Indianapolis, Indiana, 46260
Alkermes Investigational Site
Jacksonville, Florida, 32256
Alkermes Investigational Site
Jamaica, New York, 11432
Alkermes Investigational Site
Joliet, Illinois, 60435
Alkermes Investigational Site
Lafayette, Indiana, 47905
Alkermes Investigational Site
Lauderhill, Florida, 33319
Alkermes Investigational Site
Lincoln, Rhode Island, 02865
Alkermes Investigational Site
Little Rock, Arkansas, 72211
Alkermes Investigational Site
Los Alamitos, California, 90720
Alkermes Investigational Site
Los Angeles, California, 90024
Alkermes Investigational Site
Maitland, Florida, 32751
Alkermes Investigational Site
Mason, Ohio, 45040
Alkermes Investigational Site
Media, Pennsylvania, 19063
Alkermes Investigational Site
Melbourne, Florida, 32901
Alkermes Investigational Site
Memphis, Tennessee, 38119
Alkermes Investigational Site
Middleburg Heights, Ohio, 44130
Alkermes Investigational Site
Middleton, Wisconsin, 53562
Alkermes Investigational Site
Mount Kisco, New York, 10549
Alkermes Investigational Site
National City, California, 91950
Alkermes Investigational Site
New York, New York, 10019
Alkermes Investigational Site
New York, New York, 10023
Alkermes Investigational Site
New York, New York, 10029
Alkermes Investigational Site
New York, New York, 10128
Alkermes Investigational Site
New York, New York, 10168
Alkermes Investigational Site
Newburgh, Indiana, 47630
Alkermes Investigational Site
North Miami, Florida, 33161
Alkermes Investigational Site
Norwich, Connecticut, 06360
Alkermes Investigational Site
O'Fallon, Missouri, 63368
Alkermes Investigational Site
Oak Brook, Illinois, 60523
Alkermes Investigational Site
Oakland, California, 94612
Alkermes Investigational Site
Oakland Park, Florida, 33334
Alkermes Investigational Site
Oceanside, California, 92056
Alkermes Investigational Site
Oklahoma City, Oklahoma, 73103
Alkermes Investigational Site
Oklahoma City, Oklahoma, 73112
Alkermes Investigational Site
Orange, California, 92868
Alkermes Investigational Site
Orlando, Florida, 32801
Alkermes Investigational Site
Owensboro, Kentucky, 42301
Alkermes Investigational Site
Philadelphia, Pennsylvania, 19104
Alkermes Investigational Site
Philadelphia, Pennsylvania, 19107
Alkermes Investigational Site
Pico Rivera, California, 90660
Alkermes Investigational Site
Portland, Oregon, 97210
Alkermes Investigational Site
Portland, Oregon, 97214
Alkermes Investigational Site
Princeton, New Jersey, 08540
Alkermes Investigational Site
Redlands, California, 92374
Alkermes Investigational Site
Saint Charles, Missouri, 63304
Alkermes Investigational Site
Salem, Oregon, 97301
Alkermes Investigational Site
San Antonio, Texas, 78229
Alkermes Investigational Site
San Gabriel, California, 91776
Alkermes Investigational Site
Seattle, Washington, 98104
Alkermes Investigational Site
Sherman Oaks, California, 91403
Alkermes Investigational Site
Skokie, Illinois, 60076
Alkermes Investigational Site
Smyrna, Georgia, 30080
Alkermes Investigational Site
Spokane, Washington, 99204
Alkermes Investigational Site
St Louis, Missouri, 63109
Alkermes Investigational Site
St Louis, Missouri, 63141
Alkermes Investigational Site
Staten Island, New York, 10305
Alkermes Investigational Site
Staten Island, New York, 10312
Alkermes Investigational Site
Sugar Land, Texas, 77478
Alkermes Investigational Site
Tampa, Florida, 33613
Alkermes Investigational Site
Temecula, California, 92591
Alkermes Investigational Site
The Villages, Florida, 32162
Alkermes Investigational Site
Torrance, California, 90502
Alkermes Investigational Site
Tucson, Arizona, 85712
Alkermes Investigational Site
Upland, California, 91786
Alkermes Investigational Site
Valparaiso, Indiana, 46383
Alkermes Investigational Site
Washington D.C., Maryland, 20016
Alkermes Investigational Site
Watertown, Massachusetts, 02472
Alkermes Investigational Site
Waukesha, Wisconsin, 53188
Alkermes Investigational Site
West Palm Beach, Florida, 33407
Alkermes Investigational Site
Wichita Falls, Texas, 76309
Alkermes Investigational Site
Winter Haven, Florida, 33880
Alkermes Investigational Site
Woodstock, Vermont, 05091
Alkermes Investigational Site
Worcester, Massachusetts, 01655
Germany11 sites
Alkermes Investigational Site
Achim, 28832
Alkermes Investigational Site
Berlin, 10245
Alkermes Investigational Site
Berlin, 10365
Alkermes Investigational Site
Berlin, 10629
Alkermes Investigational Site
Ellwangen, 73479
Alkermes Investigational Site
Freiburg im Breisgau, 79104
Alkermes Investigational Site
Hanover, 30159
Alkermes Investigational Site
Mainz, 55131
Alkermes Investigational Site
Oranienburg, Brandenburg, 16515
Alkermes Investigational Site
Schwerin, 19053
Alkermes Investigational Site
Stralsund, 18439
Bulgaria8 sites
Alkermes Investigational Site
Burgas, 8001
Alkermes Investigational Site
Kazanlak, 6100
Alkermes Investigational Site
Sofia, 1113
Alkermes Investigational Site
Sofia, 1431
Alkermes Investigational Site
Sofia, 1632
Alkermes Investigational Site
Varna, 9020
Alkermes Investigational Site
Veliko Tarnovo, 5000
Alkermes Investigational Site
Vratsa, 3000
Canada4 sites
Alkermes Investigational Site
Gatineau, Quebec, J8T 8JL
Alkermes Investigational Site
Halifax, Nova Scotia, B3S 1L8
Alkermes Investigational Site
Penticton, British Columbia, V2A 4M4
Alkermes Investigational Site
Québec, G3K 2P8
Poland4 sites
Alkermes Investigational Site
Bialystok, 15-879
Alkermes Investigational Site
Gdansk, 80-438
Alkermes Investigational Site
Gdansk, 80-546
Alkermes Investigational Site
Gorlice, 38-300
Australia3 sites
Alkermes Investigational Site
Frankston, Victoria, 3199
Alkermes Investigational Site
Melbourne, Victoria, 3004
Alkermes Investigational Site
Towong, Queensland, 4066
Hungary3 sites
Alkermes Investigational Site
Budapest, 1053
Alkermes Investigational Site
Budapest, 1135
Alkermes Investigational Site
Budapest, 1137
Puerto Rico2 sites
Alkermes Investigational Site
San Juan, 00918
Alkermes Investigational Site
San Juan, 00926
About this study
Official title: 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.
- Conditions
- Major Depressive Disorder
- Being tested
- ALKS 5461
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALKS 5461Drug
Sublingual tablet, taken daily
| Study group | Role | What they receive |
|---|---|---|
| ALKS 5461 | Experimental | Not described Receives: Drug: ALKS 5461 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events (AEs)
Measured: Up to 56 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2014 (estimated)
- Study startMay 2014
- Primary completion20 Nov 2017
- Study completion20 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,485 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alkermes, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sanjeev Pathak, MD, Study director, Alkermes, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02141399
- Sponsor's protocol ID
- ALK5461-208
- Status last verified
- Nov 2018
- First submitted
- 15 May 2014
- Last updated
- 14 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT02141399
- Acronym / sponsor ID
- ALK5461-208
- Conditions
- Major Depressive Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,485 participants (actual)
- Lead sponsor
- Alkermes, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2014 (actual)
- Primary completion
- 20 Nov 2017 (actual)
- Study completion
- 20 Nov 2017 (actual)
- First posted
- 19 May 2014 (estimated)
- Results
- Posted 14 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a 52-week open-label study to evaluate the safety and tolerability of ALKS 5461.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ALKS 5461 | Experimental | Drug: ALKS 5461 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALKS 5461Sublingual tablet, taken daily | Drug | ALKS 5461 |
Primary outcome
Incidence of Adverse Events (AEs)
Time frame: Up to 56 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sanjeev Pathak, MD study director
Alkermes, Inc.
158 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ALKS 5461 in people with Major Depressive Disorder, run by Alkermes, Inc. at 158 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 158 sites in United States, Germany, Bulgaria, Canada, Poland and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events (AEs) (time frame: Up to 56 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2018.