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NCT04513912 · ClinicalTrials.gov registry record · Phase 3
A Study of Seltorexant Compared to Quetiapine XR as Adjunctive Therapy to Antidepressants in Adult and Elderly Participants With Major Depressive Disorder With Insomnia Symptoms Who Have Responded Inadequately to Antidepressant Therapy
A Phase 3 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 3
- Development phase
- 757
- Enrollment target
NCT04513912: Completed Phase 3 study, sponsored by Janssen Research & Development.
NCT04513912 is a Phase 3 study that has completed, run by Janssen Research & Development. The registered enrollment target is 757 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04513912, a Phase 3 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 757 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the efficacy of seltorexant compared with quetiapine extended-release (XR) as adjunctive therapy to an antidepressant drug in treatment response 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
Responders are defined as percentage of participants with greater than or equal to (\>=) 50 percent (%) improvement in the montgomery-asberg depression rating scale (MADRS) total score from baseline. MADRS is a clinician-administered scale designed to measure depression severity and detects changes due to antidepressant treatment. The MADRS evaluates the following 10 items: apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude,
Interventions
- DRUG Seltorexant
- DRUG Quetiapine XR
- DRUG Matching placebo to Seltorexant
- DRUG Matching placebo to Quetiapine XR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 757 participants |
| Start Date | 2020-09-15 |
| Est. Completion | 2023-10-03 |
| Phase | Phase 3 |
What the finished NCT04513912 record still lists
NCT04513912 is an interventional study that assigns participants to a tested intervention. The registered 757 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 4 interventions - of which Seltorexant is the first listed.
NCT04513912 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04513912 about?
NCT04513912 is a clinical study titled "A Study of Seltorexant Compared to Quetiapine XR as Adjunctive Therapy to Antidepressants in Adult and Elderly Participants With Major Depressive Disorder With Insomnia Symptoms Who Have Responded Inadequately to Antidepressant Therapy". The purpose of this study is to assess the efficacy of seltorexant compared with quetiapine extended-release (XR) as adjunctive therapy to an antidepressant drug in treatment response in participants with major depressive disorder with insomnia symptoms (MDDIS) who have had an inadequate response to...
What is the current status of trial NCT04513912?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 757 participants. The study started on 2020-09-15. Estimated completion is 2023-10-03.
What interventions are being tested in trial NCT04513912?
The interventions under investigation include: Seltorexant (DRUG), Quetiapine XR (DRUG), Matching placebo to Seltorexant (DRUG), Matching placebo to Quetiapine XR (DRUG).
Who is sponsoring clinical trial NCT04513912?
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 NCT04513912's enrollment target sits among peer trials
757 456th of 2000 higher than 1,544 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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