NCT07573176 A Study of Seltorexant as Monotherapy in Adults and Elderly Participants With Major Depressive Disorder
| NCT ID | NCT07573176 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Janssen Research & Development, LLC |
| Condition | Depressive Disorder, Major |
| Study Type | INTERVENTIONAL |
| Enrollment | 600 participants |
| Start Date | 2026-04-30 |
| Primary Completion | 2028-08-24 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 600 participants in total. It began in 2026-04-30 with a primary completion date of 2028-08-24.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Janssen Research & Development, LLC Clinical Trial
STUDY DIRECTOR
Janssen Research & Development, LLC
Frequently Asked Questions
Who can join the NCT07573176 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 74 Years, studying Depressive Disorder, Major. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07573176 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 600 participants.
Is NCT07573176 currently recruiting?
Yes, NCT07573176 is actively recruiting participants. Contact the research team at Participate-In-This-Study1@its.jnj.com for enrollment information.
Where is the NCT07573176 trial being conducted?
This trial is being conducted at Bryant, United States, Bellflower, United States, Glendale, United States, Oceanside, United States and 11 additional locations.
Who is sponsoring the NCT07573176 clinical trial?
NCT07573176 is sponsored by Janssen Research & Development, LLC. The principal investigator is Janssen Research & Development, LLC Clinical Trial at Janssen Research & Development, LLC. The trial plans to enroll 600 participants.