Recruiting
Phase 2

ALKS 7290

Sponsor:

Alkermes, Inc.

Code:

NCT07901179

Conditions

Major Depressive Disorder (MDD)

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

ALKS 7290 Dose

Placebo

Study Details

Brief 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.

Conditions

Major Depressive Disorder (MDD)

Study ID

NCT07901179

Start date

Oct, 2026

Status verified date

Oct, 2026

Completion date

Jan, 2028

Anticipated

Primary completion date

Jan, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

180 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ALKS 7290 and Antidepressant Therapy

placebo comparator: Placebo and Antidepressant Therapy

Interventions

ALKS 7290 Dose

Daily oral ALKS 7290 with antidepressant therapy

Placebo

Daily oral placebo with antidepressant therapy

Primary outcome measure

  • Incidence of treatment-emergent adverse events [ Time Frame: Up to 8 weeks ]

Central Contacts and Locations

Central contacts

Director, Clinical Trial Manager

888-235-8008 (US Only)clinicaltrials@alkermes.com

Director, Clinical Trial Manager

571-599-2702 (Global)clinicaltrials@alkermes.com

Locations

Alkermes Investigator Site

Recruiting

Jacksonville, Florida, United States, 32256

More Information

Sponsor

Alkermes, Inc.

Last update posted

Oct 28, 2026

Last verified

Oct, 2026

Keywords

  • MDD
  • Major Depressive Disorder
  • orexin-2 receptor agonist
  • excessive daytime sleepiness
  • ALKS 7290

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-29. This information was provided to ClinicalTrials.gov by Alkermes, Inc. on 2026-10-28. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.