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 Have taken up to two antidepressant treatments started in the current episode that were stopped (withdrawn), or will be withdrawn (washed out) due to inadequate response or intolerance.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)
Must be medically stable on the basis of the following performed at screening and double-blind (DB) baseline: physical examination (including a brief neurological examination), vital signs (including blood pressure), and 12-lead electrocardiogram (ECG)
You may not be 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
Has any significant sleep disorder, including but not limited to untreated/uncontrolled conditions
Has known allergies, hypersensitivity, intolerance, or any contraindication to seltorexant or its excipients
Clareo Health | A Study of Seltorexant as Monotherapy in Adults and Elderly Participants With Major Depressive Disorder
