Major Depressive DisorderPhase 3NCT03188185
A Study of ALKS 5461 for Treatment Refractory Major Depressive Disorder (MDD)
A Phase 3 study testing ALKS 5461 in people with Major Depressive Disorder, run by Alkermes, Inc. at 35 sites in 3 countries.
Trial summary
This study will evaluate the efficacy, safety, and tolerability of adjunctive ALKS 5461 in adults who have treatment refractory MDD. 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?
- Yes, some participants may receive a placebo
- How many people
- 278 participants
- Where
- 35 sitesin 3 countries
- Study dates
- 12 Jun 2017to 5 Mar 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a Major Depressive Disorder (MDD) primary diagnosis
- Have a body mass index (BMI) of 18.0 to </= 40.0 kg/m^2
- Be willing and able to follow the study procedures and visits as outlined in the protocol (including agreeing not to enroll in any other clinical trials)
- Have inadequate responses to antidepressant therapy (ADT) in the current Major Depressive Episode (MDE)
- Additional criteria may apply
Who cannot join
- Has any finding that would compromise the safety of the subject or affect their ability to adhere to the protocol visit schedule or fulfill visit requirements
- Has any other significant medical condition (eg, neurological, psychiatric, or metabolic) or clinical symptom that could unduly risk the subject or affect the interpretation of study data
- Has any current primary diagnosis other than MDD, where primary diagnosis is defined as the primary source of current distress and functional impairment
- Has experienced hallucinations, delusions, or any psychotic symptoms in the current MDE
- Has been hospitalized for MDD within 3 months before screening
- Has used opioid agonists (eg, codeine, oxycodone, tramadol, morphine) or opioid antagonists (eg, naloxone, naltrexone) within 14 days prior to screening
Show all 12Show fewer
- Has received electroconvulsive therapy treatment within the last 2 years or within the current MDE or failed a course of electroconvulsive treatment at any time
- Has a significant risk for suicide
- Has a positive breath alcohol test at screening
- Has a positive test for drugs of abuse at screening or visit 2
- Is pregnant, planning to become pregnant, or is breastfeeding during the study
- Additional criteria may apply
Trial locations and contacts
35 sites in 3 countries.
35 sites in 3 countries
United States30 sites
Alkermes Investigational Site
Allentown, Pennsylvania, 18104
Alkermes Investigational Site
Atlanta, Georgia, 30341
Alkermes Investigative Site
Bellevue, Washington, 98007
Alkermes Investigational Site
Canton, Ohio, 44720
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, 92056
Alkermes Investigational Site
Oklahoma City, Oklahoma, 73112
Alkermes Investigational Site
Orlando, Florida, 32801
Alkermes Investigative 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 Investigative Site
Upland, California, 91786
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, 00926-3160
About this study
Official title: A Phase 3b Efficacy and Safety Study of Adjunctive ALKS 5461 in Treatment Refractory Major Depressive Disorder
This study will evaluate the efficacy, safety, and tolerability of adjunctive ALKS 5461 in adults who have treatment refractory MDD.
- Conditions
- Major Depressive Disorder
- Being tested
- ALKS 5461, ALKS 5461 Placebo
- Keywords
- Alkermes, Major Depressive Disorder, Treatment Refractory MDD, 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
Samidorphan + buprenorphine, administered sublingually
ALKS 5461 PlaceboDrug
Placebo tablet, administered sublingually
| Study group | Role | What they receive |
|---|---|---|
| ALKS 5461 | Experimental | Sublingual tablets Receives: Drug: ALKS 5461 |
| ALKS 5461 Placebo | Placebo comparator | Sublingual tablets Receives: Drug: ALKS 5461 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to the End of Treatment (EOT) in the Montgomery Asberg Depression Rating Scale-10 (MADRS-10) Scores
The MADRS-10 scale is a clinician-administered questionnaire comprised of 10 items used to measure the severity of Major Depressive Disorder (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.
Measured: Baseline and 5 weeks for Stage 1, Baseline and 6 weeks for Stage 2
Secondary outcomes (2)
Montgomery Asberg Depression Rating Scale (MADRS) Response Rate
The percentage of subjects demonstrating a MADRS-10 treatment response, defined as a >/= 50% reduction in MADRS-10 score from baseline to the end of the efficacy period (Week 5 for Stage 1, Week 6 for Stage 2). The MADRS-10 scale is a measure of the severity of Major Depressive Disorder (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).
Measured: Baseline and 5 weeks for Stage 1, Baseline and 6 weeks for Stage 2
Montgomery Asberg Depression Rating Scale (MADRS) Remission Rate
The percentage of subjects achieving remission, defined as a subject with a score </= 10 at the end of the efficacy period (Week 5 for Stage 1, Week 6 for Stage 2). The MADRS-10 scale is a measure of the severity of Major Depressive Disorder (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).the end of the efficacy period.
Measured: 5 weeks for Stage 1, 6 weeks for Stage 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2017
- Study start12 Jun 2017
- Primary completion26 Feb 2020
- Study completion5 Mar 2020
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 278 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
- NCT03188185
- Sponsor's protocol ID
- ALK5461-217
- Status last verified
- Mar 2021
- First submitted
- 9 Jun 2017
- Last updated
- 8 Apr 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 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3b Efficacy and Safety Study of Adjunctive ALKS 5461 in Treatment Refractory Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT03188185
- Acronym / sponsor ID
- ALK5461-217
- Conditions
- Major Depressive Disorder
- Keywords
- Alkermes, Major Depressive Disorder, Treatment Refractory MDD, ALKS 5461
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 278 participants (actual)
- Lead sponsor
- Alkermes, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Jun 2017 (actual)
- Primary completion
- 26 Feb 2020 (actual)
- Study completion
- 5 Mar 2020 (actual)
- First posted
- 15 Jun 2017 (actual)
- Results
- Posted 15 Mar 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 evaluate the efficacy, safety, and tolerability of adjunctive ALKS 5461 in adults who have treatment refractory MDD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ALKS 5461 | Experimental | Drug: ALKS 5461Sublingual tablets |
| ALKS 5461 Placebo | Placebo comparator | Drug: ALKS 5461 PlaceboSublingual tablets |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Have a Major Depressive Disorder (MDD) primary diagnosis
- Have a body mass index (BMI) of 18.0 to </= 40.0 kg/m^2
- Be willing and able to follow the study procedures and visits as outlined in the protocol (including agreeing not to enroll in any other clinical trials)
- Have inadequate responses to antidepressant therapy (ADT) in the current Major Depressive Episode (MDE)
- Additional criteria may apply
Key exclusion criteria (12 listed)
- Has any finding that would compromise the safety of the subject or affect their ability to adhere to the protocol visit schedule or fulfill visit requirements
- Has any other significant medical condition (eg, neurological, psychiatric, or metabolic) or clinical symptom that could unduly risk the subject or affect the interpretation of study data
- Has any current primary diagnosis other than MDD, where primary diagnosis is defined as the primary source of current distress and functional impairment
- Has experienced hallucinations, delusions, or any psychotic symptoms in the current MDE
- Has been hospitalized for MDD within 3 months before screening
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 |
| ALKS 5461 PlaceboPlacebo tablet, administered sublingually | Drug | ALKS 5461 Placebo |
Primary outcome
Change From Baseline to the End of Treatment (EOT) in the Montgomery Asberg Depression Rating Scale-10 (MADRS-10) Scores
Time frame: Baseline and 5 weeks for Stage 1, Baseline and 6 weeks for Stage 2
The MADRS-10 scale is a clinician-administered questionnaire comprised of 10 items used to measure the severity of Major Depressive Disorder (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.
2 secondary outcomes
Montgomery Asberg Depression Rating Scale (MADRS) Response Rate
Time frame: Baseline and 5 weeks for Stage 1, Baseline and 6 weeks for Stage 2
Montgomery Asberg Depression Rating Scale (MADRS) Remission Rate
Time frame: 5 weeks for Stage 1, 6 weeks for Stage 2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 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.
Sanjeev Pathak, MD study director
Alkermes, Inc.
35 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 Major Depressive Disorder, run by Alkermes, Inc. at 35 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 5 inclusion and 12 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 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 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. Some participants in this study may receive a placebo. 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 15 Mar 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?
Change From Baseline to the End of Treatment (EOT) in the Montgomery Asberg Depression Rating Scale-10 (MADRS-10) Scores (time frame: Baseline and 5 weeks for Stage 1, Baseline and 6 weeks for Stage 2). 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 8 Apr 2021.