A Study of Seltorexant as Monotherapy in Adults and Elderly Participants With Major Depressive Disorder

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Depressive Disorder, Major

In brief

The main purpose of this study is to assess how well the study drug (JNJ-42847922) works (efficacy) compared with placebo in improving depressive symptoms in participants with major depressive disorder (\[MDD\], a common mood disorder that causes a lasting feeling of sadness and a loss of interest in everyday activities) in double-blind treatment phase. Further, to evaluate long-term safety and tolerability of JNJ-42847922 in participants with MDD in the open label treatment phase.

Key facts

Study ID

NCT07573176

Run by

Janssen Research & Development, LLC

People needed

600

Starts

2026-04-30

Expected to finish

2029-05-03

Last updated by the study team

2026-07-31

Who can join

Age: 18 and older, up to 74. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Meet diagnostic and statistical manual of mental disorders-5th edition (DSM-5) diagnostic criteria for major depressive disorder (MDD), without psychotic features based upon clinical assessment
• Experienced at least one MDD episode prior to their current episode
• Current episode of MDD must be a minimum of 2 weeks in duration
• Must meet one of the following criteria regarding current medication status.
• Can be presenting for a new episode of MDD on no antidepressant treatment; however, must have been treated with an antidepressant medication in a prior episode for a minimum of 6 weeks at a stable dose at or above the minimum therapeutic level (medical record/source document).
• OR
• Have taken up to two antidepressant treatments started in the current episode that were stopped (withdrawn), or will be withdrawn (washed out) due to inadequate response or intolerance.
• Body Mass Index (BMI) between 18 and 40 kilograms per square meter (kg/m\^2)
• Must be medically stable on the basis of the following performed at screening and double-blind (DB) baseline: physical examination (including a brief neurological examination), vital signs (including blood pressure), and 12-lead electrocardiogram (ECG)

You may not qualify if…

• Use of ketamine/esketamine in the current depressive episode (up to 2 doses are allowed prior to screening)
• Has treatment-resistant depression (TRD)
• Has a primary DSM-5 diagnosis of panic disorder, generalized anxiety disorder, social anxiety disorder, or specific phobia which has been the primary focus of psychiatric treatment within the past 2 years
• Current active DSM-5 diagnosis of obsessive-compulsive disorder, posttraumatic stress disorder, anorexia nervosa, bulimia nervosa, or fibromyalgia
• Has a history or current diagnosis of a psychotic disorder, bipolar disorder, autism spectrum disorder, borderline personality disorder, or somatoform disorders
• Has dementia, any dementing disease, intellectual disability, or neurocognitive disorder
• Has a current or recent history of homicidal ideation or serious suicidal ideation within the past 3 months or a history of suicidal behavior within the past 6 months
• Has a history of moderate-to-severe substance use disorder including alcohol use disorder according to DSM-5 criteria within 6 months
• Has any significant sleep disorder, including but not limited to untreated/uncontrolled conditions
• Has known allergies, hypersensitivity, intolerance, or any contraindication to seltorexant or its excipients

Where it is running

• CI Trials — Bellflower, California, United States (enrolling)
• Behavioral Research Specialists LLC — Glendale, California, United States (enrolling)
• Excell Research Inc — Oceanside, California, United States (enrolling)
• NRC Research Institute — Orange, California, United States (enrolling)
• Cenexel — Riverside, California, United States (enrolling)
• Sunwise Clinical Research — Walnut Creek, California, United States (enrolling)
• UHC Research — Doral, Florida, United States (enrolling)
• Reliable Clinical Research — Hialeah, Florida, United States (enrolling)
• Nuovida Research Center — Miami, Florida, United States (enrolling)
• IPTB Clinical Research — Tampa, Florida, United States (enrolling)
• Health Synergy Clinical Research — West Palm Beach, Florida, United States (enrolling)
• Agile Clinical Research Trials, LLC — Atlanta, Georgia, United States (enrolling)
• Accelerated Clinical Research Group LLC — Snellville, Georgia, United States (enrolling)
• Chicago Research Center — Chicago, Illinois, United States (enrolling)
• Adams Clinical Boston — Boston, Massachusetts, United States (enrolling)
• Adams Clinical Watertown — Watertown, Massachusetts, United States (enrolling)
• CenExel Marlton NJ — Marlton, New Jersey, United States (enrolling)
• Integrative Clinical Trials LLC — Brooklyn, New York, United States (enrolling)
• Bioscience Research LLC — Mount Kisco, New York, United States (enrolling)
• Fieve Clinical Research Inc — New York, New York, United States (enrolling)
• Manhattan Behavioral Medicine — New York, New York, United States (enrolling)
• Patient Priority Clinical Sites LLC — Cincinnati, Ohio, United States (enrolling)
• Conrad Clinical Research — Edmond, Oklahoma, United States (enrolling)
• Sooner Clinical Research — Oklahoma City, Oklahoma, United States (enrolling)
• Alpine Research Organization — Clinton, Utah, United States (enrolling)

Full record on ClinicalTrials.gov

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