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

Part of paid clinical trials in Walnut Creek, California.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT07573176
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 74 Years
Healthy Volunteers
Not accepted

Interventions

  • Seltorexant — DRUG
    Seltorexant tablet will be administered orally.
  • Placebo — DRUG
    Placebo tablet will be administered orally.

Study Details

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.

Key Dates

Start date
Apr 30, 2026
Status verified
Jun 2026
Primary completion
Aug 24, 2028
Completion
May 3, 2029

Study Design

Enrollment
600 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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).

Primary Outcome Measure

Double Blind (DB) Treatment Phase: Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score in Participants with Major Depressive Disorder with Moderate-to-Severe Insomnia Symptoms (MDDIS) [ Time Frame: Baseline up to Day 43 ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
Sunwise Clinical ResearchWalnut CreekCalifornia94596-
UHC ResearchDoralFlorida33178-
Nuovida Research CenterMiamiFlorida33186-
Health Synergy Clinical ResearchWest Palm BeachFlorida33407-
Accelerated Clinical Research Group LLCSnellvilleGeorgia30078-
Adams Clinical WatertownWatertownMassachusetts02472-
Integrative Clinical Trials LLCBrooklynNew York11229-
Patient Priority Clinical Sites LLCCincinnatiOhio45215-
Alpine Research OrganizationClintonUtah84015-
Northwest Clinical Research CenterBellevueWashington98007-

Find similar trials in Walnut Creek, CA

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
Sunwise Clinical Research· Walnut Creek, CAUHC Research· Doral, FLNuovida Research Center· Miami, FLHealth Synergy Clinical Research· West Palm Beach, FLAccelerated Clinical Research Group LLC· Snellville, GAAdams Clinical Watertown· Watertown, MA

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