A Study of Seltorexant as Monotherapy in Adults and Elderly Participants With Major Depressive Disorder
A Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate Efficacy and Safety of Seltorexant as Monotherapy in Adult and Elderly Participants With Major Depressive Disorder (MDD) and an Open-label Long-term Extension Treatment With Seltorexant
Janssen Research & Development, LLC
600 participants
Apr 30, 2026
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria9
- 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- Have taken up to two antidepressant treatments started in the current episode that were stopped (withdrawn), or will be withdrawn (washed out) due to inadequate response or intolerance.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)
Exclusion Criteria10
- 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
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Interventions
Seltorexant tablet will be administered orally.
Placebo tablet will be administered orally.
Locations(5)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07573176