Refractory Major Depressive DisorderPhase 3NCT03610048
A Long Term Study of ALKS 5461 in the Treatment of Refractory Major Depressive Disorder (MDD)
A Phase 3 study testing ALKS 5461 in people with Refractory Major Depressive Disorder, run by Alkermes, Inc. at 34 sites in 3 countries.
Trial summary
This study will assess the long-term safety and tolerability of ALKS 5461 as an adjunctive treatment for refractory MDD. Read more about this study
- Who is it for?
- Ages 18 to 72 years
- Conditions the study is for
- Refractory 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
- 175 participants
- Where
- 34 sitesin 3 countries
- Study dates
- 9 Aug 2018to 1 May 2020
- 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 72 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Completed study ALK5461-217
- Be willing to abide by the contraception requirements as outlined in the study protocol
- Be willing and able to follow the study procedures and visits as outlined in the protocol
- Additional criteria may apply
Who cannot join
- Pregnant, planning to become pregnant, or breastfeeding
- A positive urine drug test for drugs of abuse
- Poses a current suicide risk
- Additional criteria may apply
Trial locations and contacts
34 sites in 3 countries.
34 sites in 3 countries
United States29 sites
Alkermes Investigational Site
Allentown, Pennsylvania, 18104
Alkermes Investigational Site
Atlanta, Georgia, 30341
Alkermes Investigational Site
Bellevue, Washington, 98007
Alkermes Investigational Site
Canton, Ohio, 44718
Alkermes Investigational Site
Cincinnati, Ohio, 45215
Alkermes Investigational Site
Dallas, Texas, 75390
Alkermes Investigational Site
Decatur, Georgia, 30030
Alkermes Investigational Site
DeSoto, Texas, 75115
Alkermes Investigational Site
Hollywood, Florida, 33024
Alkermes Investigational Site
Jacksonville, Florida, 32256
Alkermes Investigational Site
Jamaica, New York, 11432
Alkermes Investigational Site
Lauderhill, Florida, 33319
Alkermes Investigational Site
Little Rock, Arkansas, 72211
Alkermes Investigational Site
Los Alamitos, California, 90720
Alkermes Investigational Site
Memphis, Tennessee, 38119
Alkermes Investigational Site
Mount Kisco, New York, 10549
Alkermes Investigational Site
O'Fallon, Missouri, 63368
Alkermes Investigational Site
Oceanside, California, 92054
Alkermes Investigational Site
Oklahoma City, Oklahoma, 73112
Alkermes Investigational Site
Orlando, Florida, 32801
Alkermes Investigational Site
Palm Bay, Florida, 32905
Alkermes Investigational Site
Pico Rivera, California, 90660
Alkermes Investigational Site
Pikesville, Maryland, 21208
Alkermes Investigational Site
Redlands, California, 92374
Alkermes Investigational Site
Santa Ana, California, 92705
Alkermes Investigational Site
Sherman Oaks, California, 91403
Alkermes Investigational Site
Temecula, California, 92591
Alkermes Investigational Site
Tucson, Arizona, 85712
Alkermes Investigational Site
Woodstock, Vermont, 05091
Australia3 sites
Alkermes Investigational Site
Frankston, Victoria, 3199
Alkermes Investigational Site
Noble Park, Victoria, 3174
Alkermes Investigational Site
Richmond, Victoria, 3121
Puerto Rico2 sites
Alkermes Investigational Site
San Juan, 00918
Alkermes Investigational Site
San Juan, 00926
About this study
Official title: A Phase 3b Extension Study of Adjunctive ALKS 5461 in the Treatment of Refractory Major Depressive Disorder
This study will assess the long-term safety and tolerability of ALKS 5461 as an adjunctive treatment for refractory MDD.
- Conditions
- Refractory Major Depressive Disorder
- Being tested
- ALKS 5461
- Keywords
- Alkermes, Major depressive disorder, Depression, ALKS 5461
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALKS 5461Drug
samidorphan + buprenorphine administered sublingually
| Study group | Role | What they receive |
|---|---|---|
| ALKS 5461 | Experimental | Sublingual tablets Receives: Drug: ALKS 5461 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Treatment-emergent Adverse Events (TEAEs)
Number and percentage of subjects experiencing TEAEs
Measured: Up to 68 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start9 Aug 2018
- Primary completion1 May 2020
- Study completion1 May 2020
Why it stopped: Sponsor Decision
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 Refractory 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
- Model description
- Open-label
- Masking
- None (open label)
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alkermes, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alkermes Medical Director, Study director, Alkermes, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03610048
- Sponsor's protocol ID
- ALK5461-218
- Status last verified
- Jun 2021
- First submitted
- 26 Jul 2018
- Last updated
- 16 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3b Extension Study of Adjunctive ALKS 5461 in the Treatment of Refractory Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT03610048
- Acronym / sponsor ID
- ALK5461-218
- Conditions
- Refractory Major Depressive Disorder
- Keywords
- Alkermes, Major depressive disorder, Depression, ALKS 5461
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor Decision
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Alkermes, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Aug 2018 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 1 Aug 2018 (actual)
- Results
- Posted 16 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess the long-term safety and tolerability of ALKS 5461 as an adjunctive treatment for refractory MDD.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open-label
| Arm | Type | Receives |
|---|---|---|
| ALKS 5461 | Experimental | Drug: ALKS 5461Sublingual tablets |
Who may qualify
- Ages
- 18 to 72 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Completed study ALK5461-217
- Be willing to abide by the contraception requirements as outlined in the study protocol
- Be willing and able to follow the study procedures and visits as outlined in the protocol
- Additional criteria may apply
Key exclusion criteria (4 listed)
- Pregnant, planning to become pregnant, or breastfeeding
- A positive urine drug test for drugs of abuse
- Poses a current suicide risk
- Additional criteria may apply
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 5461samidorphan + buprenorphine administered sublingually | Drug | ALKS 5461 |
Primary outcome
Number of Subjects With Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to 68 weeks
Number and percentage of subjects experiencing TEAEs
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Alkermes Medical Director study director
Alkermes, Inc.
34 sites in 3 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 Refractory Major Depressive Disorder, run by Alkermes, Inc. at 34 sites in 3 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 4 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: stopped early, as of the sponsor's last update on 16 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in United States, Australia, Puerto Rico. 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 16 Jul 2021). 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?
Number of Subjects With Treatment-emergent Adverse Events (TEAEs) (time frame: Up to 68 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 16 Jul 2021.