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NCT04951609 · ClinicalTrials.gov registry record · Phase 1
A Study of Seltorexant as Adjunctive Therapy to Antidepressants in Adolescents With Major Depressive Disorder Who Have an Inadequate Response to Selective Serotonin Reuptake Inhibitor (SSRI) and Psychotherapy
A Phase 1 study, sponsored by Janssen Research & Development.
- Terminated
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
NCT04951609: Clinical Trial Phase 1 study, sponsored by Janssen Research & Development.
NCT04951609 is a Phase 1 study that was terminated before completion, run by Janssen Research & Development. The registered enrollment target is 31 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04951609, a Phase 1 study, was terminated before completion, sponsored by Janssen Research & Development.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the safety and tolerability of Seltorexant as adjunctive therapy to an antidepressant in adolescents with major depressive disorder (MDD) in the short-term compared with placebo.
Primary Outcome
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs are adverse events with onset during the double-blind treatment phase or that are a consequence of a preexisting condition that has worsened since baseline.
Interventions
- DRUG Placebo
- DRUG Seltorexant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2021-09-02 |
| Est. Completion | 2024-04-08 |
| Phase | Phase 1 |
Why NCT04951609 stopped before completion
NCT04951609 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04951609 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04951609 about?
NCT04951609 is a clinical study titled "A Study of Seltorexant as Adjunctive Therapy to Antidepressants in Adolescents With Major Depressive Disorder Who Have an Inadequate Response to Selective Serotonin Reuptake Inhibitor (SSRI) and Psychotherapy". The purpose of this study is to assess the safety and tolerability of Seltorexant as adjunctive therapy to an antidepressant in adolescents with major depressive disorder (MDD) in the short-term compared with placebo.
What is the current status of trial NCT04951609?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2021-09-02. Estimated completion is 2024-04-08.
What interventions are being tested in trial NCT04951609?
The interventions under investigation include: Placebo (DRUG), Seltorexant (DRUG).
Who is sponsoring clinical trial NCT04951609?
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 NCT04951609's enrollment target sits among peer trials
31 1322nd of 2000 higher than 669 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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