RecruitingDepressive Disorder, Major

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

Eligible age

18–74 yrs

Accepts

All genders

Locations

11 states

Healthy volunteers

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About this study

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.

Sponsor: Janssen Research & Development, LLC

You may qualify if…

✓ 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 for a minimum of 6 weeks at a stable dose at or above the minimum therapeutic level (medical record/source document).
✓ OR
✓ 2. Have taken up to two antidepressant treatments started in the current episode that were stopped (withdrawn), or will be withdrawn (washed out) due to inadequate response or intolerance.
✓ Body Mass Index (BMI) between 18 and 40 kilograms per square meter (kg/m\^2)

You may not qualify if…

✕ 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
✕ Has a history or current diagnosis of a psychotic disorder, bipolar disorder, autism spectrum disorder, borderline personality disorder, or somatoform disorders
✕ Has dementia, any dementing disease, intellectual disability, or neurocognitive disorder
✕ Has a current or recent history of homicidal ideation or serious suicidal ideation within the past 3 months or a history of suicidal behavior within the past 6 months
✕ Has a history of moderate-to-severe substance use disorder including alcohol use disorder according to DSM-5 criteria within 6 months