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RecruitingNCT07901179Updated Oct 28, 2026

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 interventional study of ALKS 7290 Dose and Placebo in Major Depressive Disorder (MDD), sponsored by Alkermes, Inc.. Recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-28.

Sponsored by Alkermes, Inc. · Phase 2, Interventional, and Treatment

Updated Oct 28, 2026Newly registeredGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
180
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Major Depressive Disorder (MDD)

Keywords

  • MDD
  • Major Depressive Disorder
  • orexin-2 receptor agonist
  • excessive daytime sleepiness
  • ALKS 7290
03

In context

Depressive Disorder, Major

3,041 studies on the registry are indexed under Depressive Disorder, Major; 588 are open to participants now.

This study's planned enrollment of 180 is above the median of 79 across 2,530 interventional studies indexed under Depressive Disorder, Major.

Browse Depressive Disorder, Major studies →

Lead sponsor

Alkermes, Inc. is the lead sponsor of 83 studies on the registry; 9 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 5 (56%) have results posted.

Browse Alkermes, Inc. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Meets the 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 within 18 to 35 kg/m2 at Screening

Exclusion criteria

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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
180 participants (estimated)

Study arms

  • Experimental
    ALKS 7290 and Antidepressant Therapy

    Drug: ALKS 7290 Dose

  • Placebo comparator
    Placebo and Antidepressant Therapy

    Drug: Placebo

Interventions

  • DrugALKS 7290 Dose

    Daily oral ALKS 7290 with antidepressant therapy

  • DrugPlacebo

    Daily oral placebo with antidepressant therapy

06

What researchers measure

Primary outcomes

  1. Incidence of treatment-emergent adverse events

    Time frame: Up to 8 weeks

Secondary outcomes

  1. Change from Baseline to Week 6 in Montgomery-Asberg Depression Rating Scale (MADRS) total score

    Time frame: Baseline to Week 6

  2. Change in Baseline to Week 6 in Clinical Global Impression-Severity (CGI-S)

    Time frame: Baseline to Week 6

07

Study locations

1 of 1 sites recruiting
  • Alkermes Investigator Site
    Jacksonville, Florida 32256, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for Jan 2028, 15 months later.

Of 96 industry-sponsored phase 2 interventional studies under Depressive Disorder, Major, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 23. This study's planned 15 months is below that.

Counting every sponsor, half of 195 studies reached it within 22 months; a quarter within 14 and three quarters within 37.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 22, 2026
First posted
Oct 28, 2026
StartEst.
Oct 2026
Primary completionEst.
Jan 2028
CompletionEst.
Jan 2028
Last update
Oct 28, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 28, 2026
Show all 1 update
  1. Oct 28, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07901179
Lead sponsor
Alkermes, Inc.
Responsible party
Sponsor
First posted
Oct 28, 2026
Start date
Oct 2026 (estimated)
Primary completion
Jan 2028 (estimated)
Completion
Jan 2028 (estimated)
Last update
Oct 28, 2026

Study contacts

Director, Clinical Trial Manager
Contact
clinicaltrials@alkermes.com
888-235-8008 (US Only)
Director, Clinical Trial Manager
Contact
clinicaltrials@alkermes.com
571-599-2702 (Global)
Medical Director, MD
study director · Alkermes, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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