Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING Phase 3

Phase 3 Study of Adjunctive Treatment With Seltorexant in Adult and Elderly Participants With Major Depressive Disorder and Insomnia Symptoms

NCT06559306 · View on ClinicalTrials.gov ↗

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

FieldValue
Enrollment Target 752 participants
Start Date 2024-07-25
Est. Completion 2026-12-30
Phase Phase 3

Sponsor

Janssen Research & Development

442 total trials

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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 752 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 442 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06559306 reports 20 study locations spanning 7 distinct geographic areas — top geographies include California, Arizona, Arkansas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06559306?

This trial is sponsored by Janssen Research & Development, which has 442 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial