ALKS 7290 added to antidepressants for adults with major depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2 interventional trial evaluating the safety and potential benefit of ALKS 7290 as an adjunctive oral therapy for adults with Major Depressive Disorder who have not fully responded to antidepressants. Participants will be randomized to receive either ALKS 7290 at a specified dose or placebo, in addition to their current medication. The study monitors efficacy, safety, tolerability, and changes in depressive symptoms over a defined period. Eligibility requires DSM-5 confirmed MDD, stability on permitted meds, inadequate antidepressant response, and moderate to severe symptoms. Key exclusions include certain psychiatric conditions and significant cognitive or substance-use concerns.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Where it's running

• Alkermes Investigator Site
  Jacksonville, Florida, United States Recruiting

Study contacts

• Study coordinator: Director, Clinical Trial Manager
• Email: clinicaltrials@alkermes.com
• Phone: 888-235-8008 (US Only)

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.