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A Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate Efficacy and Safety of Seltorexant as Monotherapy in Adult and Elderly Participants With Major Depressive Disorder (MDD) and an Open-label Long-term Extension Treatment With Seltorexant

Status: Recruiting
Location: See all (10) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 74
Healthy Volunteers: f
View:

• 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.

‣ 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

⁃ Have taken up to two antidepressant treatments started in the current episode that were stopped (withdrawn), or will be withdrawn (washed out) due to inadequate response or intolerance.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)

Locations
United States
California
Sunwise Clinical Research
RECRUITING
Walnut Creek
Florida
UHC Research
RECRUITING
Doral
Nuovida Research Center
RECRUITING
Miami
Health Synergy Clinical Research
RECRUITING
West Palm Beach
Georgia
Accelerated Clinical Research Group LLC
RECRUITING
Snellville
Massachusetts
Adams Clinical Watertown
RECRUITING
Watertown
New York
Integrative Clinical Trials LLC
RECRUITING
Brooklyn
Ohio
Patient Priority Clinical Sites LLC
RECRUITING
Cincinnati
Utah
Alpine Research Organization
RECRUITING
Clinton
Washington
Northwest Clinical Research Center
RECRUITING
Bellevue
Contact Information
Primary
Study Contact
Participate-In-This-Study1@its.jnj.com
844-434-4210
Time Frame
Start Date: 2026-04-30
Estimated Completion Date: 2029-05-03
Participants
Target number of participants: 600
Treatments
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).
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).
Related Therapeutic Areas
Sponsors
Leads: Janssen Research & Development, LLC

This content was sourced from clinicaltrials.gov

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