Actively Recruiting
A Study to Evaluate Efficacy and Safety of Seltorexant as Monotherapy in Adults and Elderly With Major Depressive Disorder and Open-label Long-term Extension
Led by Janssen Research & Development, LLC · Updated on 2026-06-05
600
Participants Needed
10
Research Sites
36 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the drug seltorexant compared with placebo to see how well it improves depressive symptoms in adults and elderly participants diagnosed with major depressive disorder (MDD), a common mood disorder causing lasting sadness and loss of interest. The study also aims to assess the long-term safety and tolerability of seltorexant in participants during an open-label treatment phase. Participants will be randomly assigned to receive either seltorexant or a matching placebo tablet once daily for 42 days in the double-blind treatment phase. Those who qualify for the open-label phase will then receive seltorexant daily for up to 6 months. The study includes both a double-blind phase and an extended open-label phase to monitor treatment effects and safety over time. During the study, participants will undergo assessments including depression rating scales, safety monitoring for adverse events, vital signs, suicidality evaluations, withdrawal symptom checks, and measurements of sexual function, body weight, body mass index, waist circumference, and laboratory tests. The primary outcome focuses on changes in depression severity, while the open-label phase tracks safety and tolerability. Participation may last up to six months depending on the study phase and individual progress.
CONDITIONS
Brief 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...
- Adults aged 18 to 74 years
- Diagnosed with major depressive disorder (MDD) without psychotic features according to DSM-5
- Experienced at least one prior MDD episode before current episode
- Current MDD episode lasting at least 2 weeks
- Either not on antidepressant treatment for current episode but previously treated for at least 6 weeks at stable dose, or have stopped/will stop up to two antidepressant treatments in current episode due to inadequate response or intolerance
- Body mass index 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 current depressive episode (more than 2 doses not allowed)
- Diagnosis of treatment-resistant depression
- Primary diagnosis in past 2 years of panic disorder, generalized anxiety disorder, social anxiety disorder, or specific phobia as main psychiatric focus
- Current 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 within last 3 to 6 months
- Moderate-to-severe substance use disorder including alcohol use disorder within 6 months
- Significant untreated or uncontrolled sleep disorder
- Known allergies or contraindications to seltorexant or its components
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 42 days
Participants receive either seltorexant or placebo tablets orally once daily in a double-blind treatment phase.
Multiple visits during the 6-week treatment period
Duration - Up to 6 months
Eligible participants receive seltorexant tablets daily in an open-label treatment phase lasting up to 6 months.
Visits occur periodically throughout the open-label phase
Duration - Up to 14 days
Participants are monitored for withdrawal symptoms and safety assessments for up to 14 days after treatment ends or early withdrawal.
1 to 2 visits after treatment completion or early withdrawal
Trial Site Locations
Total: 10 locations
1
Sunwise Clinical Research
Walnut Creek, California, United States, 94596
Actively Recruiting
2
UHC Research
Doral, Florida, United States, 33178
Actively Recruiting
3
Nuovida Research Center
Miami, Florida, United States, 33186
Actively Recruiting
4
Health Synergy Clinical Research
West Palm Beach, Florida, United States, 33407
Actively Recruiting
5
Accelerated Clinical Research Group LLC
Snellville, Georgia, United States, 30078
Actively Recruiting
6
Adams Clinical Watertown
Watertown, Massachusetts, United States, 02472
Actively Recruiting
7
Integrative Clinical Trials LLC
Brooklyn, New York, United States, 11229
Actively Recruiting
8
Patient Priority Clinical Sites LLC
Cincinnati, Ohio, United States, 45215
Actively Recruiting
9
Alpine Research Organization
Clinton, Utah, United States, 84015
Actively Recruiting
10
Northwest Clinical Research Center
Bellevue, Washington, United States, 98007
Actively Recruiting
Research Team
S
Study Contact
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here