N
← Back to Search
Sponsored

Accelerate Your Clinical Trial Recruitment

Reach thousands of high-intent patients matching your specific inclusion criteria.

Start Campaign
RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: Janssen Research & Development, LLC • ClinicalTrials.gov ID: NCT07573176

Registry updated: 2026-10-01
Ad

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Check Eligibility →

Description

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.

Interventions

  • Seltorexant (Drug)
    Seltorexant tablet will be administered orally.
  • Placebo (Drug)
    Placebo tablet will be administered orally.

Eligibility 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 regarding current medication status. 1. Can be presenting for a new episode of MDD with no adequate antidepressant treatment started in the current episode; 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. 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 Have taken up to two antidepressant treatments started in the current episode that were stopped (withdrawn), or will be withdrawn (washed out) due to inadequate response as defined by the Massachusetts general hospital antidepressant treatment response questionnaire (MGH-ATRQ) * Body Mass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

Conditions

Depressive Disorder, Major

Locations

  • SanRo Clinical Research Group LLC WCG Clinical Network — Bryant, Arkansas, United States
  • CI Trials — Bellflower, California, United States
  • Behavioral Research Specialists LLC — Glendale, California, United States
  • Excell Research Inc — Oceanside, California, United States
  • NRC Research Institute — Orange, California, United States
  • Cenexel — Riverside, California, United States
  • Sunwise Clinical Research — Walnut Creek, California, United States
  • UHC Research — Doral, Florida, United States
  • Reliable Clinical Research — Hialeah, Florida, United States
  • Pharmax Research Clinic Inc — Miami, Florida, United States
  • Nuovida Research Center — Miami, Florida, United States
  • IPTB Clinical Research — Tampa, Florida, United States
  • Health Synergy Clinical Research — West Palm Beach, Florida, United States
  • Agile Clinical Research Trials, LLC — Atlanta, Georgia, United States
  • Accelerated Clinical Research Group LLC — Snellville, Georgia, United States
  • Chicago Research Center — Chicago, Illinois, United States
  • Pharmasite Research, Inc. — Baltimore, Maryland, United States
  • Adams Clinical Boston — Boston, Massachusetts, United States
  • Adams Clinical Watertown — Watertown, Massachusetts, United States
  • Vector Clinical Trials — Las Vegas, Nevada, United States
  • CenExel Marlton NJ — Marlton, New Jersey, United States
  • Integrative Clinical Trials LLC — Brooklyn, New York, United States
  • SPRI Clinical Trials, LLC — Brooklyn, New York, United States
  • Bioscience Research LLC — Mount Kisco, New York, United States
  • Fieve Clinical Research Inc — New York, New York, United States
  • Adams Clinical Harlem — New York, New York, United States
  • Manhattan Behavioral Medicine — New York, New York, United States
  • Magnolia Clinical Research LLC — Cary, North Carolina, United States
  • Patient Priority Clinical Sites LLC — Cincinnati, Ohio, United States
  • Conrad Clinical Research — Edmond, Oklahoma, United States
  • Sooner Clinical Research — Oklahoma City, Oklahoma, United States
  • Future Search Trials of Dallas — Dallas, Texas, United States
  • Alpine Research Organization — Clinton, Utah, United States
  • Northwest Clinical Research Center — Bellevue, Washington, United States
  • Instituto Apice — Salvador, Brazil
  • Centro Integrado Facili — São Bernardo do Campo, Brazil
  • BR Trials — São Paulo, Brazil
  • Medical Arts Research Health Group — North Vancouver, British Columbia, Canada
  • Providence Care Hospital — Kingston, Ontario, Canada
  • Beijing Huilongguan Hospital — Beijing, China
  • University Malaya Medical Centre — Kuala Lumpur, Malaysia
  • Chung Shan Medical University Hospital — Taichung, Taiwan
  • Taipei Mackay Memorial Hospital — Taipei, Taiwan
  • Taipei Medical University Hospital — Taipei, Taiwan
  • Taipei Veterans General Hospital — Taipei, Taiwan
Sponsored

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record