A Study of Seltorexant as Monotherapy in Adults and Elderly Participants With Major Depressive Disorder

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-74
SponsorJanssen Research & Development, LLC

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 tolerability of JNJ-42847922 in participants with MDD in the open label treatment phase.

Eligibility criteria

Qualifiers

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.

Disqualifiers

Use of ketamine/esketamine in the current depressive episode (up to 2 doses are allowed prior to screening)

Has treatment-resistant depression (TRD)

Has a primary DSM-5 diagnosis of panic disorder, generalized anxiety disorder, social anxiety disorder, or specific phobia which has been the primary focus of psychiatric treatment within the past 2 years

Current active DSM-5 diagnosis of obsessive-compulsive disorder, posttraumatic stress disorder, anorexia nervosa, bulimia nervosa, or fibromyalgia

Trial design

Treatments tested in this trial

  • Seltorexant
  • Placebo

Treatment groups

600 Participants
are divided into 2 treatment groups