Actively Recruiting
A Study of Seltorexant as Monotherapy in Adults and Elderly Participants With Major Depressive Disorder
Led by Janssen Research & Development, LLC · Updated on 2026-05-08
600
Participants Needed
5
Research Sites
157 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of Seltorexant as Monotherapy in Adults and Elderly Participants With Major Depressive Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Meet DSM-5 criteria for major depressive disorder (MDD) without psychotic features
- Have experienced at least one prior episode of MDD before the current episode
- Current MDD episode must last at least 2 weeks
- Must either be starting a new MDD episode without current antidepressant treatment but with past antidepressant treatment for at least 6 weeks at a stable dose, or have taken up to two antidepressants in the current episode that were stopped or will be stopped due to inadequate response or intolerance
- Body Mass Index (BMI) between 18 and 40 kg/m²
- Medically stable based on physical exam, vital signs, and 12-lead ECG at screening and baseline
You will not qualify if you...
- Use of ketamine or esketamine in the current depressive episode (more than 2 doses)
- Treatment-resistant depression
- Primary diagnosis of panic disorder, generalized anxiety disorder, social anxiety disorder, or specific phobia treated primarily in the last 2 years
- Current active diagnosis of obsessive-compulsive disorder, posttraumatic stress disorder, anorexia nervosa, bulimia nervosa, or fibromyalgia
- History or current diagnosis of psychotic disorder, bipolar disorder, autism spectrum disorder, borderline personality disorder, or somatoform disorders
- Dementia, intellectual disability, or neurocognitive disorder
- Recent history of serious suicidal ideation or behavior
- Moderate-to-severe substance use disorder including alcohol use disorder within 6 months
- Significant untreated or uncontrolled sleep disorders
- Allergies or intolerance to seltorexant or its ingredients
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 5 locations
1
UHC Research
Doral, Florida, United States, 33178
Actively Recruiting
2
Nuovida Research Center
Miami, Florida, United States, 33186
Actively Recruiting
3
Accelerated Clinical Research Group LLC
Snellville, Georgia, United States, 30078
Actively Recruiting
4
Patient Priority Clinical Sites LLC
Cincinnati, Ohio, United States, 45215
Actively Recruiting
5
Northwest Clinical Research Center
Bellevue, Washington, United States, 98007
Actively Recruiting
Research Team
S
Study Contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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