A Study of Seltorexant as Monotherapy in Adults and Elderly Participants With Major Depressive Disorder
Recruiting
Phase 3
Interventional Study
Depressive Disorder, Major
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 74
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 600 (estimated)
- Sponsor
- Janssen Research & Development, LLC · Industry
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About This Trial
The main purpose of this study is to assess how well the study drug (JNJ-42847922) works (efficacy) compared with placebo in improving depressive symptoms in participants with major depressive disorder (\[MDD\], a common mood disorder that causes a lasting feeling of sadness and a loss of interest in everyday activities) in double-blind treatment phase. Further, to evaluate long-term safety and to…
Trial Locations
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Eligibility Criteria
Inclusion criteria:
* Meet diagnostic and statistical manual of mental disorders-5th edition (DSM-5) diagnostic criteria for major depressive disorder (MDD), without psychotic features based upon clinical assessment
* Experienced at least one MDD episode prior to their current episode
* Current epi…
Contacts