ClinicalTrials.gov record
Phase 3 Study of Adjunctive Treatment With Seltorexant in Adult and Elderly Participants With Major Depressive Disorder and Insomnia Symptoms
ClinicalTrials.gov ID: NCT06559306
Public ClinicalTrials.gov record NCT06559306. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
ClinicalTrials.gov public records Last synced May 9, 2026, 6:11 PM EDT
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Study identification
- NCT ID
- NCT06559306
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Janssen Research & Development, LLC
- Industry
- Enrollment
- 752 participants
Conditions and interventions
Conditions
Interventions
- Placebo Drug
- Selective Serotonin Reuptake Inhibitor (SSRI)/Serotonin-Norepinephrine Reuptake Inhibitor (SNRI) Drug
- Seltorexant Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 74 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 24, 2024
- Primary completion
- Dec 29, 2026
- Completion
- Dec 29, 2026
- Last update posted
- May 7, 2026
2024 – 2026
United States locations
- U.S. sites
- 84
- U.S. states
- 22
- U.S. cities
- 68
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | Recruiting |
| Chandler Clinical Trials | Chandler | Arizona | 85224 | Completed |
| University of Arizona | Tucson | Arizona | 85724 | Recruiting |
| SanRo Clinical Research Group LLC WCG Clinical Network | Bryant | Arkansas | 72022 | Recruiting |
| Preferred Research Partners | Little Rock | Arkansas | 72211 | Completed |
| PAMOJA Clinical Institute LLC | Anaheim | California | 92801 | Recruiting |
| Axiom Research | Colton | California | 92324 | Recruiting |
| Elite Research Network 6 | Encino | California | 91316 | Completed |
| Behavioral Research Specialists LLC | Glendale | California | 91206 | Completed |
| WR PRI Los Alamitos | Los Alamitos | California | 90720 | Completed |
| Excell Research Inc | Oceanside | California | 92056 | Recruiting |
| Prospective Research Innovations Inc | Rancho Cucamonga | California | 91730 | Completed |
| Anderson Clinical Research | Redlands | California | 92374 | Recruiting |
| Lumos Clinical Research Center LLC | San Jose | California | 95124 | Recruiting |
| Syrentis Clinical Research | Santa Ana | California | 92705 | Completed |
| California Neuroscience Research | Sherman Oaks | California | 91403 | Completed |
| Mountain View Clinical Research | Denver | Colorado | 80209 | Recruiting |
| UConn Health Center | Farmington | Connecticut | 06030 | Recruiting |
| Clinical Research of Brandon | Brandon | Florida | 33511 | Recruiting |
| AGA Clinical Trials | Hialeah | Florida | 33012 | Recruiting |
| Reliable Clinical Research | Hialeah | Florida | 33012 | Recruiting |
| Advanced Research Institute of Miami | Homestead | Florida | 33033 | Recruiting |
| Clinical NeuroScience Solutions Inc | Jacksonville | Florida | 32256 | Recruiting |
| Multi Specialty Research Associates Inc | Lake City | Florida | 32055 | Completed |
| Alcanza Clinical Research | Largo | Florida | 33777 | Completed |
| Pharmax Research Clinic Inc | Miami | Florida | 33126 | Recruiting |
| Miami Dade Medical Research Institute | Miami | Florida | 33176 | Recruiting |
| Nuovida Research Center | Miami | Florida | 33186 | Recruiting |
| Aqualane Clinical Research | Naples | Florida | 34105 | Completed |
| Bravo Health Care Center | North Bay Village | Florida | 33141 | Completed |
| Nova Psychiatry INC | Orlando | Florida | 32803 | Recruiting |
| Florida Center for TMS | Saint Augustine | Florida | 32086 | Completed |
| University of South Florida | Tampa | Florida | 33613 | Completed |
| Psych Me Medical Research Inc | Tampa | Florida | 33614 | Recruiting |
| Interventional Psychiatry of Tampa Bay | Tampa | Florida | 33629 | Recruiting |
| Health Synergy Clinical Research | West Palm Beach | Florida | 33407 | Recruiting |
| Conquest Research | Winter Park | Florida | 32789 | Completed |
| Advanced Discovery Research | Atlanta | Georgia | 30318 | Recruiting |
| Agile Clinical Research Trials, LLC | Atlanta | Georgia | 30328 | Active, not recruiting |
| iResearch Atlanta LLC | Decatur | Georgia | 30030 | Recruiting |
| Peachford Hospital-Atlanta Behavorial Research | Dunwoody | Georgia | 30338 | Completed |
| iResearch Savannah | Savannah | Georgia | 31405 | Completed |
| Accelerated Clinical Research Group LLC | Snellville | Georgia | 30078 | Recruiting |
| Renew Health Clinical Research | Snellville | Georgia | 30078 | Completed |
| Northwestern University | Chicago | Illinois | 60611 | Recruiting |
| MetroMed Clinical Research | Chicago | Illinois | 60614 | Completed |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | Recruiting |
| Revive Research Institute | Elgin | Illinois | 60123 | Completed |
| Baber Research Group | Naperville | Illinois | 60563 | Recruiting |
| Boston Clinical Trials | Boston | Massachusetts | 02131 | Completed |
| Adams Clinical LLC | Watertown | Massachusetts | 02472 | Recruiting |
| Mankato Clinic | Mankato | Minnesota | 56001 | Recruiting |
| Redbird Research | Las Vegas | Nevada | 89119 | Completed |
| Oasis Clinical Research LLC | Las Vegas | Nevada | 89121 | Completed |
| ActivMed Practices and Research | Portsmouth | New Hampshire | 03801 | Completed |
| Integrative Clinical Trials LLC | Brooklyn | New York | 11229 | Recruiting |
| SPRI Clinical Trials, LLC | Brooklyn | New York | 11235 | Recruiting |
| University at Buffalo Psychiatry | Buffalo | New York | 14202 | Completed |
| Bioscience Research LLC | Mount Kisco | New York | 10549 | Recruiting |
| Fieve Clinical Research Inc | New York | New York | 10017 | Recruiting |
| Hapworth Psychiatric Medical PLLC | New York | New York | 10022 | Completed |
| Lucian Miron Manu MD Psychiatry PC | Woodbury | New York | 11797 | Completed |
| IMA Clinical Research PC 3 | Hickory | North Carolina | 28601 | Completed |
| Haidar Almhana Nieding | Avon Lake | Ohio | 44012 | Completed |
| Patient Priority Clinical Sites LLC | Cincinnati | Ohio | 45215 | Recruiting |
| University of Cincinnati College of Medicine | Cincinnati | Ohio | 45219 | Completed |
| The Ohio State University | Columbus | Ohio | 43210 | Recruiting |
| North Star Medical Research | Middleburg Heights | Ohio | 44130 | Completed |
| Conrad Clinical Research | Edmond | Oklahoma | 73013 | Recruiting |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | Recruiting |
| Clinical Trials of South Carolina | Charleston | South Carolina | 29406 | Recruiting |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | Completed |
| The University of Texas at Austin | Austin | Texas | 78712 | Completed |
| BioBehavioral Research of Austin PC | Austin | Texas | 78759 | Completed |
| Houston Clinical Trials LLC | Bellaire | Texas | 77401 | Recruiting |
| Relaro Medical Trials | Dallas | Texas | 75243 | Completed |
| North Texas Clinical Trials | Fort Worth | Texas | 76104 | Recruiting |
| VAST Clinical Research | Garland | Texas | 75041 | Completed |
| Baylor College of Medicine | Houston | Texas | 77030 | Recruiting |
| DM Clinical Research | Houston | Texas | 77081 | Recruiting |
| R and H Clinical Research | Stafford | Texas | 77477 | Recruiting |
| Grayline Research Center | Wichita Falls | Texas | 76309 | Active, not recruiting |
| Cedar Clinical Research | Draper | Utah | 84020 | Completed |
| Core Clinical Research | Everett | Washington | 98201 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 121 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06559306, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 7, 2026 · Synced May 9, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06559306 live on ClinicalTrials.gov.