A Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate Efficacy and Safety of Seltorexant as Monotherapy in Adult and Elderly Participants With Major Depressive Disorder (MDD) and an Open-label Long-term Extension Treatment With Seltorexant
Janssen Research & Development, LLC
Summary
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 tolerability of JNJ-42847922 in participants with MDD in the open label treatment phase.
Eligibility
- Age range
- 18–74 years
- Sex
- All
- Healthy volunteers
- No
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 episode of MDD must be a minimum of 2 weeks in duration * Must meet one of the following criteria regarding current medication status. 1. Can be presenting for a new episode of MDD on no antidepressant treatment; however, must have been treated with an antidepressant medication in a prior episode fo…
Interventions
- DrugSeltorexant
Seltorexant tablet will be administered orally.
- DrugPlacebo
Placebo tablet will be administered orally.
Locations (5)
- UHC ResearchDoral, Florida
- Nuovida Research CenterMiami, Florida
- Accelerated Clinical Research Group LLCSnellville, Georgia
- Patient Priority Clinical Sites LLCCincinnati, Ohio
- Northwest Clinical Research CenterBellevue, Washington