ALKS 7290 added to antidepressants for adults with major depressive disorder
Tests ALKS 7290 alongside antidepressants in adults with major depressive disorder.
Plain-language title generated from the registry record
Registry title: A Study to Evaluate the Safety and Efficacy of ALKS 7290 as an Adjunctive Therapy to Antidepressants in Adult Participants With Major Depressive Disorder
Key facts
- Where
- Jacksonville, United StatesSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07901179, who can take part
Where in United States
- JacksonvilleJacksonville, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Alkermes, Inc.
- Trial code
- NCT07901179
- Record updated
- 28 October 2026
- Original description
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 full original descriptionShow less
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.
Inclusion: 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: 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; Any other psychiatric condition that could interfere with participation in the study; Participant poses a current suicide risk as assessed by the Investigator or as confirmed by the C-SSRS.