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NCT07573176 · ClinicalTrials.gov registry record · Phase 3

A Study of Seltorexant as Monotherapy in Adults and Elderly Participants With Major Depressive Disorder

A Phase 3 study, sponsored by Janssen Research & Development.

Recruiting
Registry status
Phase 3
Development phase
600
Enrollment target

NCT07573176: Recruiting Phase 3 study, sponsored by Janssen Research & Development.

NCT07573176 is a Phase 3 study that is actively recruiting participants, run by Janssen Research & Development. The registered enrollment target is 600 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (22% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07573176, a Phase 3 study, is actively recruiting participants, sponsored by Janssen Research & Development.

RECRUITING
Registry status
Phase 3
Development phase
600 participants
Enrollment target

Study Summary

The main purpose of this study is to assess how well the study drug (JNJ-42847922) works (efficacy) compared with placebo in improving depressive symptoms in participants with major depressive disorder (\[MDD\], a common mood disorder that causes a lasting feeling of sadness and a loss of interest in everyday activities) in double-blind treatment phase. Further, to evaluate long-term safety and tolerability of JNJ-42847922 in participants with MDD in the open label treatment phase.

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.

Interventions

  • DRUG Placebo
  • DRUG Seltorexant

Trial Details

FieldValue
Enrollment Target 600 participants
Start Date 2026-04-30
Est. Completion 2029-05-03
Phase Phase 3
Janssen Research & Development

593 total trials

What NCT07573176 shows while recruiting

NCT07573176 is an interventional study that assigns participants to a tested intervention. The registered 600 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (22% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT07573176 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT07573176 about?

NCT07573176 is a clinical study titled "A Study of Seltorexant as Monotherapy in Adults and Elderly Participants With Major Depressive Disorder". The main purpose of this study is to assess how well the study drug (JNJ-42847922) works (efficacy) compared with placebo in improving depressive symptoms in participants with major depressive disorder (\[MDD\], a common mood disorder that causes a lasting feeling of sadness and a loss of interest i...

What is the current status of trial NCT07573176?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 600 participants. The study started on 2026-04-30. Estimated completion is 2029-05-03.

What interventions are being tested in trial NCT07573176?

The interventions under investigation include: Placebo (DRUG), Seltorexant (DRUG).

Who is sponsoring clinical trial NCT07573176?

This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT07573176's enrollment target sits among peer trials

600 608th of 2000 higher than 1,363 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT07573176, the US trial registry maintained by the National Library of Medicine. NCT07573176 (mid enrollment · none site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.