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NCT06559306 · ClinicalTrials.gov registry record · Phase 3
Phase 3 Study of Adjunctive Treatment With Seltorexant in Adult and Elderly Participants With Major Depressive Disorder and Insomnia Symptoms
A Phase 3 study of Depressive Disorder, Major, sponsored by Janssen Research & Development.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 752
- Enrollment target
- 20
- Study locations
NCT06559306: Recruiting Phase 3 study of Depressive Disorder, Major, sponsored by Janssen Research & Development.
NCT06559306 is a Phase 3 study of Depressive Disorder, Major that is actively recruiting participants, run by Janssen Research & Development. The registered enrollment target is 752 participants, above the 228-participant average among 52 other Depressive Disorder, Major trials with a reported enrollment target (230% higher). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06559306, a Phase 3 study of Depressive Disorder, Major, is actively recruiting participants, sponsored by Janssen Research & Development.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 752 participants
- Enrollment target
- 20
- Study locations
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).
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Seltorexant
- DRUG Selective Serotonin Reuptake Inhibitor (SSRI)/Serotonin-Norepinephrine Reuptake Inhibitor (SNRI)
Study Locations (20)
California
- PAMOJA Clinical Institute LLC - Anaheim
- Axiom Research - Colton
- Elite Research Network - Encino
- Behavioral Research Specialists LLC - Glendale
- WR PRI Los Alamitos - Los Alamitos
- Excell Research Inc - Oceanside
- Prospective Research Innovations Inc - Rancho Cucamonga
- Anderson Clinical Research - Redlands
- Lumos Clinical Research Center LLC - San Jose
- Syrentis Clinical Research - Santa Ana
- California Neuroscience Research - Sherman Oaks
Arizona
- Chandler Clinical Trials - Chandler
- University of Arizona - Tucson
Arkansas
- SanRo Clinical Research Group LLC WCG Clinical Network - Bryant
- Preferred Research Partners - Little Rock
Florida
- Clinical Research of Brandon - Brandon
- AGA Clinical Trials - Hialeah
Alabama
- University of Alabama at Birmingham - Birmingham
Colorado
- Mountain View Clinical Research - Denver
Connecticut
- UConn Health Center - Farmington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 752 participants |
| Start Date | 2024-07-25 |
| Est. Completion | 2026-12-30 |
| Phase | Phase 3 |
What NCT06559306 shows while recruiting
NCT06559306 is an interventional study that assigns participants to a tested intervention. The registered 752 participants enrollment target is mid-sized for trials with a published cap, above the 228-participant average among 52 other Depressive Disorder, Major trials with a reported enrollment target (230% higher).
The record links to 1 condition, with Depressive Disorder, Major appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT06559306 names 20 study sites across 7 states, led by California, Arizona, Arkansas.
Frequently Asked Questions
What is clinical trial NCT06559306 about?
NCT06559306 is a clinical study titled "Phase 3 Study of Adjunctive Treatment With Seltorexant in Adult and Elderly Participants With Major Depressive Disorder and Insomnia Symptoms". 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 symptom...
What is the current status of trial NCT06559306?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 752 participants. The study started on 2024-07-25. Estimated completion is 2026-12-30.
What conditions does trial NCT06559306 study?
This clinical trial studies the following conditions: Depressive Disorder, Major.
What interventions are being tested in trial NCT06559306?
The interventions under investigation include: Placebo (DRUG), Seltorexant (DRUG), Selective Serotonin Reuptake Inhibitor (SSRI)/Serotonin-Norepinephrine Reuptake Inhibitor (SNRI) (DRUG).
Who is sponsoring clinical trial NCT06559306?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06559306 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Depressive Disorder, Major
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06559306's enrollment target sits among peer trials
752 4th of 52 higher than 49 of 52 other Depressive Disorder, Major trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Depressive Disorder, Major trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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