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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 is a Phase 3 study that has completed, run by Janssen Research & Development. The registered enrollment target is 588 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04533529
The ClinicalTrials.gov registry entry for NCT04533529 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 588 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 2 interventions - of which Placebo is the first listed.
NCT04533529 reports 0 study locations.
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.
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