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NCT04533529 · ClinicalTrials.gov registry record · Phase 3
A Study of Seltorexant as Adjunctive Therapy to Antidepressants in Adult and Elderly Participants With Major Depressive Disorder With Insomnia Symptoms Who Have Responded Inadequately to Antidepressant and Long-term Safety Extension Treatment With Seltorexant
A Phase 3 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 3
- Development phase
- 588
- Enrollment target
NCT04533529: Completed Phase 3 study, sponsored by Janssen Research & Development.
NCT04533529 is a Phase 3 study that has completed, run by Janssen Research & Development. The registered enrollment target is 588 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (24% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04533529, a Phase 3 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 588 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the efficacy of seltorexant compared with placebo as 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 an selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI) in double-blind treatment phase and to assess the long-term safety and tolerability of seltorexant as adjunctive therapy to an antidepressant in participants with major depressive disorder (MDD) in open-label treatment phase.
Primary Outcome
The MADRS is a clinician-rated scale designed to measure depression severity and detected changes due to antidepressant intervention. Scale has 10 items(apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts) each of which was scored from 0 (not present or normal) to 6 (severe or continuous presence of symptoms). MADRS total score is sum of scores from individual que
Interventions
- DRUG Placebo
- DRUG Seltorexant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 588 participants |
| Start Date | 2020-09-16 |
| Est. Completion | 2024-04-30 |
| Phase | Phase 3 |
What the finished NCT04533529 record still lists
NCT04533529 is an interventional study that assigns participants to a tested intervention. The registered 588 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 (24% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04533529 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04533529 about?
NCT04533529 is a clinical study titled "A Study of Seltorexant as Adjunctive Therapy to Antidepressants in Adult and Elderly Participants With Major Depressive Disorder With Insomnia Symptoms Who Have Responded Inadequately to Antidepressant and Long-term Safety Extension Treatment With Seltorexant". The purpose of this study is to assess the efficacy of seltorexant compared with placebo as 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 antidepres...
What is the current status of trial NCT04533529?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 588 participants. The study started on 2020-09-16. Estimated completion is 2024-04-30.
What interventions are being tested in trial NCT04533529?
The interventions under investigation include: Placebo (DRUG), Seltorexant (DRUG).
Who is sponsoring clinical trial NCT04533529?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04533529's enrollment target sits among peer trials
588 645th of 2000 higher than 1,356 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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