Phase 3 Study of Adjunctive Treatment With Seltorexant in Adult and Elderly Participants With Major Depressive Disorder and Insomnia Symptoms (NCT06559306)
A Two-Part Multicenter, Double-Blind, Randomized Placebo-Controlled Study to Evaluate Efficacy and Safety and the Maintenance of Effect of 20-(Milligram) mg Seltorexant as Adjunctive Therapy to Antidepressants in Adult and Elderly Patients With Major Depressive Disorder With Insomnia Symptoms
🩺 Plain-English Summary (8th-Grade Level)
The purpose of this study is to know how well seltorexant works, and also to evaluate safety and maintenance effect of seltorexant compared with placebo as an adjunctive therapy to an antidepressant in improving depressive symptoms in participants with major depressive disorder with insomnia symptoms (MDDIS) who have had an inadequate response to current antidepressant therapy with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI).
Who can join: Review the eligibility criteria below.
Location: University of Alabama at Birmingham — Birmingham, Alabama
Age range: 18 Years to 74 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (205 Sites)
Showing the first 25 of 205 sites.
- University of Alabama at Birmingham — Birmingham, Alabama
- Chandler Clinical Trials — Chandler, Arizona
- University of Arizona — Tucson, Arizona
- SanRo Clinical Research Group LLC WCG Clinical Network — Bryant, Arkansas
- Preferred Research Partners — Little Rock, Arkansas
- PAMOJA Clinical Institute LLC — Anaheim, California
- Axiom Research — Colton, California
- Elite Research Network 6 — Encino, California
- Behavioral Research Specialists LLC — Glendale, California
- WR PRI Los Alamitos — Los Alamitos, California
- Excell Research Inc — Oceanside, California
- Prospective Research Innovations Inc — Rancho Cucamonga, California
- Anderson Clinical Research — Redlands, California
- Lumos Clinical Research Center LLC — San Jose, California
- Syrentis Clinical Research — Santa Ana, California
- California Neuroscience Research — Sherman Oaks, California
- Mountain View Clinical Research — Denver, Colorado
- UConn Health Center — Farmington, Connecticut
- Clinical Research of Brandon — Brandon, Florida
- AGA Clinical Trials — Hialeah, Florida
- Reliable Clinical Research — Hialeah, Florida
- Advanced Research Institute of Miami — Homestead, Florida
- Clinical NeuroScience Solutions Inc — Jacksonville, Florida
- Multi Specialty Research Associates Inc — Lake City, Florida
- Alcanza Clinical Research — Largo, Florida
📞 Contact the Study Coordinator
Phone: (844) 434-4210
Email: Participate-In-This-Study1@its.jnj.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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Explore by condition: All Depressive Disorder, Major clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.