A Study of Seltorexant as Adjunctive Therapy to Antidepressants in Adolescents With Major Depressive Disorder Who Have an Inadequate Response to Selective Serotonin Reuptake Inhibitor (SSRI) and Psychotherapy

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT04951609
Phase
PHASE1
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Seltorexant — DRUG
    Participants will receive a single oral dose of seltorexant.
  • Placebo — DRUG
    Participants will receive matching placebo orally.

Study Details

The purpose of this study is to assess the safety and tolerability of Seltorexant as adjunctive therapy to an antidepressant in adolescents with major depressive disorder (MDD) in the short-term compared with placebo.

Key Dates

Start date
Sep 2, 2021
Status verified
Apr 2025
Primary completion
Apr 8, 2024
Completion
Apr 8, 2024

Study Design

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

Arms

  • Experimental: Seltorexant
    Participants will receive weight based dose of Seltorexant orally once daily from Day 1 to Day 42 (until the end of Week 6). Participants will continue baseline selective serotonin reuptake inhibitor (SSRI) antidepressant (Fluoxetine or escitalopram) orally once daily.
  • Placebo Comparator: Placebo
    Participants will receive matching placebo tablets to seltorexant orally once daily from Day 1 to Day 42 (until the end of Week 6).

Primary Outcome Measure

Number of Participants with Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Up to 12 weeks ]

Locations (12)

FacilityCityStateZIPSite coordinators
Southwest Autism Research and Resource CenterPhoenixArizona85006-
Advanced Research Center IncAnaheimCalifornia92805-
University of California at San DiegoSan DiegoCalifornia92103-8620-
Yale UniversityNew HavenConnecticut06520-
Sarkis Clinical TrialsGainesvilleFlorida32607-
APG Research LLCOrlandoFlorida32803-
Baber Research GroupNapervilleIllinois60563-
University of Cincinnati Medical CenterCincinnatiOhio45219-
CincyScienceWest ChesterOhio45069-
Vanderbilt UniversityNashvilleTennessee37212-
University of Texas Southwestern Medical CenterDallasTexas75247-
Family Psychiatry of The WoodlandsThe WoodlandsTexas77381-

Find similar trials in Phoenix, AZ

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
Southwest Autism Research and Resource Center· Phoenix, AZAdvanced Research Center Inc· Anaheim, CAUniversity of California at San Diego· San Diego, CAYale University· New Haven, CTSarkis Clinical Trials· Gainesville, FLAPG Research LLC· Orlando, FL

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