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

Detailed 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 and confirmed by the SCID-CT diagnosed with first depressive episode prior to age 55 * Experienced at least one MDD episode prior to their current episode based on clinician-confirmed MDD diagnosis/MDE and documented in source records * Current episode of MDD must be a minimum of 8 weeks in duration and maximum of 24 months duration * Must meet one of the following criteria regard…

Interventions

Drug
Seltorexant
Seltorexant tablet will be administered orally.
Drug
Placebo
Placebo tablet will be administered orally.

Locations (45)

SanRo Clinical Research Group LLC WCG Clinical Network
Bryant, Arkansas
CI Trials
Bellflower, California
Behavioral Research Specialists LLC
Glendale, California
Excell Research Inc
Oceanside, California
NRC Research Institute
Orange, California
Cenexel
Riverside, California