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180 Participants NeededMy employer runs this trial

ALKS 7290 for Depression

DC
Overseen ByDirector, Clinical Trial Manager
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Alkermes, Inc.
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

MD

Medical Director, MD

Principal Investigator

Alkermes, Inc.

Are You a Good Fit for This Trial?

This trial is for adults diagnosed with major depressive disorder who are already taking antidepressants but still have symptoms, including excessive daytime sleepiness. People with certain other medical or psychiatric conditions may not be able to join.

Inclusion Criteria

Is otherwise healthy as determined by medical evaluation, including medical history, physical examination, laboratory tests, and cardiac monitoring
I have been diagnosed with major depressive disorder by a mental health professional.
Has a BMI within 18 to 35 kg/m2 at Screening
See 3 more

Exclusion Criteria

I have been diagnosed with schizophrenia, schizoaffective disorder, bipolar disorder, or a moderate to severe substance use disorder.
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
See 1 more

What Are the Treatments Tested in This Trial?

Interventions

  • ALKS 7290

Trial Overview

The study tests ALKS 7290, a new oral medication, as an add-on treatment to current antidepressants compared to a placebo (inactive pill) in adults with depression. Participants are randomly assigned to either group.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: ALKS 7290 and Antidepressant TherapyExperimental Treatment1 Intervention
Group II: Placebo and Antidepressant TherapyPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Alkermes, Inc.

Lead Sponsor

Trials
118
Recruited
27,200+

Richard Pops

Alkermes, Inc.

Chief Executive Officer since 1991

BA in Economics from Stanford University

Dr. Craig Hopkinson

Alkermes, Inc.

Chief Medical Officer since 2017

MD

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