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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 74 Years
Eligible Sex
All
Accepts 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 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 Have taken up to two antidepressant treatments started in the current episode that were stopped (withdrawn), or will be withdrawn (washed out) due to inadequate response or intolerance.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)

Exclusion Criteria

  • 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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Seltorexant 		Participants will receive seltorexant tablet orally once daily, from Day 1 to Day 42 in double blind (DB) treatment phase. Eligible participants who will enter the open label (OL) treatment phase will receive seltorexant tablet daily from OL baseline until the end of phase/ early withdrawal (EW) visit (up to 6 months).
  • Drug: Seltorexant
    Seltorexant tablet will be administered orally.
    Other names:
    • JNJ-42847922
Placebo Comparator
Placebo 		Participants will receive matching placebo tablet orally once daily from Day 1 to Day 42 in double-blind treatment phase. Eligible participants who will enter the OL treatment phase will receive seltorexant tablet daily from OL baseline until the end of phase/ EW visit (up to 6 months).
  • Drug: Seltorexant
    Seltorexant tablet will be administered orally.
    Other names:
    • JNJ-42847922
  • Drug: Placebo
    Placebo tablet will be administered orally.

Recruiting Locations

CI Trials
Bellflower, California 90706

Excell Research Inc
Oceanside, California 92056

Sunwise Clinical Research
Walnut Creek, California 94596

UHC Research
Doral, Florida 33178

Nuovida Research Center
Miami, Florida 33186

IPTB Clinical Research
Tampa, Florida 33629

Health Synergy Clinical Research
West Palm Beach, Florida 33407

Accelerated Clinical Research Group LLC
Snellville, Georgia 30078

Adams Clinical Boston
Boston, Massachusetts 02116

Adams Clinical Watertown
Watertown, Massachusetts 02472

CenExel Marlton NJ
Marlton, New Jersey 08053

Integrative Clinical Trials LLC
Brooklyn, New York 11229

Manhattan Behavioral Medicine
New York, New York 10036

Patient Priority Clinical Sites LLC
Cincinnati, Ohio 45215

Alpine Research Organization
Clinton, Utah 84015

Northwest Clinical Research Center
Bellevue, Washington 98007

More Details

Status
Recruiting
Sponsor
Janssen Research & Development, LLC

Study Contact

Study Contact
844-434-4210
Participate-In-This-Study1@its.jnj.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.