Major Depressive Disorder (MDD)Phase 2NCT07901179
A Study to Evaluate the Safety and Efficacy of ALKS 7290 as an Adjunctive Therapy to Antidepressants in Adult Participants With Major Depressive Disorder
A Phase 2 study testing ALKS 7290 Dose in people with Major Depressive Disorder (MDD), run by Alkermes, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to assess the efficacy, safety and tolerability of ALKS 7290 following oral administration in adult participants with Major Depressive Disorder. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder (MDD)
- What is being tested?
- ALKS 7290 Dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Jan 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meets the DSM-5 criteria for MDD, as confirmed by both MINI and an adequate clinical psychiatric evaluation.
- Is otherwise healthy as determined by medical evaluation, including medical history, physical examination, laboratory tests, and cardiac monitoring.
- Participants must be stable on permitted medication prior to screening.
- An inadequate response to an adequate dosage of antidepressant therapy in the current depressive episode.
- Symptoms of depression that are considered moderate to severe, based on assessments completed with the study team during both screening and baseline visits.
- Has a BMI within 18 to 35 kg/m2 at Screening
Who cannot join
- Diagnosis of schizophrenia, schizoaffective disorder, or bipolar I or II disorder, moderate to severe substance use disorder
- Significant problems with memory, thinking, learning or understanding that could make it difficult to complete study activities or follow study instructions. This includes conditions such as dementia or other disorders affecting thinking and memory that have been present within the past two years.
- Participant poses a current suicide risk as assessed by the Investigator or as confirmed by the C-SSRS
- Any other psychiatric condition that could interfere with participation in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Alkermes Investigator Site
Jacksonville, Florida, 32256
About this study
Official title: A Phase 2, Randomized, Double-Blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of ALKS 7290 as an Adjunctive Therapy to Antidepressants in Adult Participants With Major Depressive Disorder
The purpose of this study is to assess the efficacy, safety and tolerability of ALKS 7290 following oral administration in adult participants with Major Depressive Disorder.
- Conditions
- Major Depressive Disorder (MDD)
- Being tested
- ALKS 7290 Dose, Placebo
- Keywords
- MDD, Major Depressive Disorder, orexin-2 receptor agonist, excessive daytime sleepiness, ALKS 7290
- Medical subject headings
- Depressive Disorder, Major, Disorders of Excessive Somnolence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALKS 7290 DoseDrug
Daily oral ALKS 7290 with antidepressant therapy
PlaceboDrug
Daily oral placebo with antidepressant therapy
| Study group | Role | What they receive |
|---|---|---|
| ALKS 7290 and Antidepressant Therapy | Experimental | Not described Receives: Drug: ALKS 7290 Dose |
| Placebo and Antidepressant Therapy | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events
Measured: Up to 8 weeks
Secondary outcomes (2)
Change from Baseline to Week 6 in Montgomery-Asberg Depression Rating Scale (MADRS) total score
Measured: Baseline to Week 6
Change in Baseline to Week 6 in Clinical Global Impression-Severity (CGI-S)
Measured: Baseline to Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive Disorder (MDD)Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alkermes, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, MD, Study director, Alkermes, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07901179
- Sponsor's protocol ID
- ALKS 7290-202
- Status last verified
- Oct 2026
- First submitted
- 22 Oct 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-Blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of ALKS 7290 as an Adjunctive Therapy to Antidepressants in Adult Participants With Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT07901179
- Acronym / sponsor ID
- ALKS 7290-202
- Conditions
- Major Depressive Disorder (MDD)
- Keywords
- MDD, Major Depressive Disorder, orexin-2 receptor agonist, excessive daytime sleepiness, ALKS 7290
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Alkermes, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 28 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the efficacy, safety and tolerability of ALKS 7290 following oral administration in adult participants with Major Depressive Disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ALKS 7290 and Antidepressant Therapy | Experimental | Drug: ALKS 7290 Dose |
| Placebo and Antidepressant Therapy | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Meets the DSM-5 criteria for MDD, as confirmed by both MINI and an adequate clinical psychiatric evaluation.
- Is otherwise healthy as determined by medical evaluation, including medical history, physical examination, laboratory tests, and cardiac monitoring.
- Participants must be stable on permitted medication prior to screening.
- An inadequate response to an adequate dosage of antidepressant therapy in the current depressive episode.
- Symptoms of depression that are considered moderate to severe, based on assessments completed with the study team during both screening and baseline visits.
Key exclusion criteria (4 listed)
- Diagnosis of schizophrenia, schizoaffective disorder, or bipolar I or II disorder, moderate to severe substance use disorder
- Significant problems with memory, thinking, learning or understanding that could make it difficult to complete study activities or follow study instructions. This includes conditions such as dementia or other disorders affecting thinking and memory that have been present within the past two years.
- Participant poses a current suicide risk as assessed by the Investigator or as confirmed by the C-SSRS
- Any other psychiatric condition that could interfere with participation in the study.
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 7290 DoseDaily oral ALKS 7290 with antidepressant therapy | Drug | ALKS 7290 and Antidepressant Therapy |
| PlaceboDaily oral placebo with antidepressant therapy | Drug | Placebo and Antidepressant Therapy |
Primary outcome
Incidence of treatment-emergent adverse events
Time frame: Up to 8 weeks
2 secondary outcomes
Change from Baseline to Week 6 in Montgomery-Asberg Depression Rating Scale (MADRS) total score
Time frame: Baseline to Week 6
Change in Baseline to Week 6 in Clinical Global Impression-Severity (CGI-S)
Time frame: Baseline to Week 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Medical Director, MD study director
Alkermes, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ALKS 7290 Dose in people with Major Depressive Disorder (MDD), run by Alkermes, Inc. at 1 site in United States.
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 6 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: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Director, Clinical Trial Manager (888-235-8008 (US Only), clinicaltrials@alkermes.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment-emergent adverse events (time frame: Up to 8 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 28 Oct 2026.