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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 is a Phase 3 study that has completed, run by Janssen Research & Development. The registered enrollment target is 757 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04513912
The ClinicalTrials.gov registry entry for NCT04513912 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 757 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Seltorexant is the first listed.
NCT04513912 reports 0 study locations.
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.
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