A Study of Seltorexant as Adjunctive Therapy to Antidepressants in Adult and Elderly Participants With Major Depressive Disorder With Insomnia Symptoms Who Have Responded Inadequately to Antidepressant Therapy

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT04532749
Phase
PHASE3
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Seltorexant — DRUG
    Participants will receive Seltorexant tablets.
  • Placebo — DRUG
    Participants will receive matching placebo tablets.

Study Details

The purpose of this study is to assess the efficacy of Seltorexant compared with placebo as adjunctive therapy to an antidepressant in improving depressive symptoms in participants with major depressive disorder with insomnia symptoms (MDDIS) who have had an inadequate response to current antidepressant therapy with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI).

Key Dates

Start date
Sep 15, 2020
Status verified
May 2025
Primary completion
May 24, 2022
Completion
Jul 14, 2022

Study Design

Enrollment
212 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Seltorexant
    Participants will receive Seltorexant orally once daily from Day 1 to Day 42 (until the end of Week 6).
  • Placebo Comparator: Placebo
    Participants will receive matching placebo tablets orally once daily from Day 1 to Day 42 (until the end of Week 6).

Primary Outcome Measure

Change From Baseline to Day 43 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score [ Time Frame: Baseline (Day 1), Day 43 ]

Locations (26)

FacilityCityStateZIPSite coordinators
Altea Research InstitutePhoenixArizona85012-
Preferred Research PartnersLittle RockArkansas72211-
Behavioral Research Specialists LLCGlendaleCalifornia91206-
Sun Valley Research CenterImperialCalifornia92251-
Alliance for ResearchLong BeachCalifornia90807-
Excell Research IncOceansideCalifornia92056-
California Neuroscience Research Medical Group, Inc.Sherman OaksCalifornia91403-
Innova Clinical TrialsMiamiFlorida33133-
Pharmax Research Clinic IncMiamiFlorida33126-
Harmony Clinical Research IncNorth Miami BeachFlorida33162-
Medical Research Group of Central FloridaOrange CityFlorida32763-
Synexus Research OrlandoOrlandoFlorida32806-
Stedman Clinical TrialsTampaFlorida33613-
Compass Research LLC-Bioclinica ResearchThe VillagesFlorida32162-
Synexus Clinical Research US IncAtlantaGeorgia30328-
Rush University Medical CenterChicagoIllinois60612-
Uptown Research Institute, LLCChicagoIllinois60640-
Phoenix Medical Research, Inc.Prairie VillageKansas66206-
Michigan Clinical Research InstituteAnn ArborMichigan48108-
Eastside Comprehensive Medical ServicesNew YorkNew York10128-
Community Research Management Associates, Inc.CincinnatiOhio45212-
Patient Priority Clinical Sites LLCCincinnatiOhio45215-
Intend ResearchNormanOklahoma73069-
IPS Research CompanyOklahoma CityOklahoma73106-
InSite Clinical Research LLCDeSotoTexas75115-
Pillar Clinical Research, LLCRichardsonTexas75080-

Related coverage on Hipa.ai

Find similar trials in Phoenix, AZ

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
Altea Research Institute· Phoenix, AZPreferred Research Partners· Little Rock, ARBehavioral Research Specialists LLC· Glendale, CASun Valley Research Center· Imperial, CAAlliance for Research· Long Beach, CAExcell Research Inc· Oceanside, CA

Related Studies