Seltorexant (JNJ-42847922) as monotherapy for adults and older adults with major depressive disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3, randomized, double-blind trial compares seltorexant (JNJ-42847922) with placebo as a monotherapy for adults and elderly participants diagnosed with major depressive disorder. Participants may enter either medication-free or after a washout of up to two recent antidepressants, and must have a current depressive episode of at least two weeks. After the double-blind treatment phase, participants may enter an open-label phase to collect longer-term safety and tolerability data. The trial is conducted at outpatient clinical research sites with regular in-person visits for symptom rating and safety monitoring.

Why it matters

Who can join: the full rules

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 Have taken up to two antidepressant treatments started in the current episode that were stopped (withdrawn), or will be withdrawn (washed out) due to inadequate response as defined by the Massachusetts general hospital antidepressant treatment response questionnaire (MGH-ATRQ)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

Where it's running

• SanRo Clinical Research Group LLC WCG Clinical Network
  Bryant, Arkansas, United States Recruiting
• CI Trials
  Bellflower, California, United States Recruiting
• Behavioral Research Specialists LLC
  Glendale, California, United States Recruiting
• Excell Research Inc
  Oceanside, California, United States Recruiting
• NRC Research Institute
  Orange, California, United States Recruiting
• Cenexel
  Riverside, California, United States Recruiting

+3 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Study Contact
• Email: Participate-In-This-Study1@its.jnj.com
• Phone: 844-434-4210

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Brenipatide added to standard antidepressant treatment for adults with major depression

  This trial will see if adding brenipatide to your current antidepressant treatment can delay the return of major depressive symptoms in adults with major depressive disorder.

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• Esketamine plus standard care for adolescents with major depressive disorder and acute suicidal thoughts or behavior

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• Everyday movement and subjective energy (MASE Project)

  This project tests whether increasing everyday, non-exercise activity can boost feelings of energy and reduce depressive symptoms in people with major depressive disorder or recent remission.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.