Phase 3 Study of Adjunctive Treatment With Seltorexant in Adult and Elderly Participants With Major Depressive Disorder and Insomnia Symptoms
Condition(s) studied
Investigational drug(s) / intervention(s)
Seltorexant: Seltorexant will be administered orally.
Placebo: Matching Placebo tablets will be administered orally.
Selective Serotonin Reuptake Inhibitor (SSRI)/Serotonin-Norepinephrine Reuptake Inhibitor (SNRI): SSRI/SNRI will be administered orally.
Study summary
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).
Eligibility
Primary outcome measure(s)
- Part 1: Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Day 43 — Baseline, Day 43
The MADRS is a clinician-administered scale designed to measure depression severity and detects changes due to antidepressant treatment. The scale consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 60. Higher scores represent a more severe condition. - Part 2: Time from Randomization to the First Relapse in Participants Who Achieve a Stable Response — Time from randomization to the first Relapse during the maintenance phase (up to 2 years and 10 months)
Stable response is defined as a greater than equal to (\>=) 50 percent (%) reduction in the MADRS total score for the last 3 consecutive visits of the OL stabilization Phase, as assessed by the site investigator. Time from randomization to the first relapse during the DB maintenance phase in participants who achieve a stable response at the end of OL seltorexant treatment will be reported.
Trial sites (205)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | Completed |
| Chandler Clinical Trials | Chandler | Arizona | Completed |
| University of Arizona | Tucson | Arizona | Recruiting |
| SanRo Clinical Research Group LLC WCG Clinical Network | Bryant | Arkansas | Recruiting |
| Preferred Research Partners | Little Rock | Arkansas | Completed |
| PAMOJA Clinical Institute LLC | Anaheim | California | Recruiting |
| Axiom Research | Colton | California | Recruiting |
| Elite Research Network 6 | Encino | California | Completed |
| Behavioral Research Specialists LLC | Glendale | California | Recruiting |
| WR PRI Los Alamitos | Los Alamitos | California | Completed |
| Excell Research Inc | Oceanside | California | Recruiting |
| Prospective Research Innovations Inc | Rancho Cucamonga | California | Completed |
| Anderson Clinical Research | Redlands | California | Recruiting |
| Lumos Clinical Research Center LLC | San Jose | California | Recruiting |
| Syrentis Clinical Research | Santa Ana | California | Completed |
| California Neuroscience Research | Sherman Oaks | California | Completed |
| Mountain View Clinical Research | Denver | Colorado | Recruiting |
| UConn Health Center | Farmington | Connecticut | Recruiting |
| Clinical Research of Brandon | Brandon | Florida | Recruiting |
| AGA Clinical Trials | Hialeah | Florida | Recruiting |
| Reliable Clinical Research | Hialeah | Florida | Recruiting |
| Advanced Research Institute of Miami | Homestead | Florida | Recruiting |
| Clinical NeuroScience Solutions Inc | Jacksonville | Florida | Recruiting |
| Multi Specialty Research Associates Inc | Lake City | Florida | Completed |
| Alcanza Clinical Research | Largo | Florida | Completed |
| Pharmax Research Clinic Inc | Miami | Florida | Recruiting |
| Miami Dade Medical Research Institute | Miami | Florida | Recruiting |
| Nuovida Research Center | Miami | Florida | Recruiting |
| Aqualane Clinical Research | Naples | Florida | Completed |
| Bravo Health Care Center | North Bay Village | Florida | Completed |
| Nova Psychiatry INC | Orlando | Florida | Recruiting |
| Florida Center for TMS | Saint Augustine | Florida | Completed |
| University of South Florida | Tampa | Florida | Completed |
| Psych Me Medical Research Inc | Tampa | Florida | Recruiting |
| Interventional Psychiatry of Tampa Bay | Tampa | Florida | Recruiting |
| Health Synergy Clinical Research | West Palm Beach | Florida | Recruiting |
| Conquest Research | Winter Park | Florida | Completed |
| Advanced Discovery Research | Atlanta | Georgia | Recruiting |
| Agile Clinical Research Trials, LLC | Atlanta | Georgia | Recruiting |
| iResearch Atlanta LLC | Decatur | Georgia | Recruiting |
+ 165 more sites — see the full list on the official registry below.
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06559306 on ClinicalTrials.gov ↗ ← All trials in Italy