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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 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.
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).
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06559306
The ClinicalTrials.gov registry entry for NCT06559306 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 752 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 228-participant average among 52 other Depressive Disorder, Major trials with a reported enrollment target (230% higher). The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 7 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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