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

Last updated: April 25, 2025
Sponsor: Janssen Research & Development, LLC
Overall Status: Terminated

Phase

1

Condition

Depression

Treatment

Seltorexant

Placebo

Clinical Study ID

NCT04951609
CR109041
2021-000567-77
42847922MDD1016
  • Ages 12-17
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Has inadequate response to trial of at least 1, but no more than 2 antidepressanttreatments during the current major depressive episode including their currentantidepressant fluoxetine or escitalopram (SSRI). Inadequate response is determinedas less than (<) 50 percentage (%) symptom reduction after adequate antidepressanttreatment for at least 6 weeks at or above the minimum therapeutic dose prior toscreening

  • Has had access to adequate psychotherapy in the current depressive episode (based oninvestigator judgement/local guidance) prior to randomization

  • Must have Children's Depression Rating Scale-Revised (CDRS-R) total score greaterthan or equal to (>=) 48 at screening and >=40 at the baseline visit

  • Participants weighing between fifth and ninety-fifth percentile for age and sex.Obese participants greater than ninety-fifth percentile and underweight participantsbelow fifth percentile may participate following medical clearance, as long as theirbaseline weight is >=30 kilograms (kg)

  • A female participant of childbearing potential must have a negative urine pregnancytest at screening and baseline

Exclusion

Exclusion Criteria:

  • Has a history of liver or renal insufficiency, significant cardiac (example,congenital heart disease, cardiomyopathy, or tachyarrhythmias), vascular, pulmonary,gastrointestinal, endocrine (including uncontrolled hyperthyroidism), neurologic (including seizure disorder), hematologic, rheumatologic, psychiatric, or metabolicdisturbances. Stable medical conditions are allowed

  • Has current the diagnostic and statistical manual of mental disorders, fifth edition (DSM-5) diagnosis of conduct disorder, intellectual disability, autism spectrumdisorder, borderline personality disorder, somatoform disorders, or fibromyalgia. Aprior history of one or more of these disorders is allowed as long as thedisorder(s) are currently stable and major depressive disorder (MDD) is notsecondary to the original diagnosis. Has a current or prior DSM-5 diagnosis of apsychotic disorder, or bipolar disorder

  • Has a significant primary sleep disorder (example, obstructive sleep apnea,parasomnias) at screening but participants with insomnia or hypersomnia disordersare allowed

  • At significant risk of committing suicide based on history or according to theinvestigator's experience, or based on active suicidal ideation, intent or plan,item 4 or 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) within the past 3months or a history of suicidal behavior within the last 6 months

  • Has known allergies, hypersensitivity, or intolerance to seltorexant or itsexcipients

Study Design

Total Participants: 31
Treatment Group(s): 2
Primary Treatment: Seltorexant
Phase: 1
Study Start date:
September 02, 2021
Estimated Completion Date:
April 08, 2024

Study Description

The prevalence of major depression is approximately 4 percentage (%) to 8% in adolescents, with the highest incidence of MDD in child onset depression occurring during mid- to late adolescence (that is, 14 to 18 years of age). Seltorexant (JNJ-42847922) is a potent and selective antagonist of the human orexin-2 receptor (OX2R) that is being developed for the treatment of adjunctive treatment of MDD with insomnia symptoms (MDDIS).The study will be conducted in 3 phases: a screening phase (up to 30 days prior to first dose administration), a double-blind (DB) treatment phase (6 weeks), and a follow-up phase (up to 2 weeks including a telephone consult and on-site follow-up visit. The total study duration for each participant will be up to 12 weeks. Efficacy, safety, pharmacokinetics, and biomarkers will be assessed at specified time points during this study. The hypothesis for this study is that the safety, tolerability, and pharmacokinetics in the adolescent MDD population. There is no formal statistical hypothesis testing due to the exploratory and descriptive nature of this study.

Connect with a study center

  • G.Gaslini Institute

    Genova, 16147
    Italy

    Site Not Available

  • Ospedale Pediatrico Bambin Gesù

    Roma, 00165
    Italy

    Site Not Available

  • Universita Cattolica del Sacro Cuore - Fondazione Policlinico Universitario 'A. Gemelli'

    Roma, 00168
    Italy

    Site Not Available

  • Hosp. Sant Joan de Deu

    Esplugues de Llobregat, 08950
    Spain

    Site Not Available

  • Clinica Univ. de Navarra Madrid

    Madrid, 28027
    Spain

    Site Not Available

  • Hosp. Gral. Univ. Gregorio Maranon

    Madrid, 28007
    Spain

    Site Not Available

  • Hosp. Gral. Univ. Gregorio Marañon

    Madrid, 28007
    Spain

    Active - Recruiting

  • Hosp. Univ. Ramon Y Cajal

    Madrid, 28034
    Spain

    Site Not Available

  • Hosp. Univ. Pta. de Hierro Majadahonda

    Majadahonda, 28222
    Spain

    Site Not Available

  • Corporacio Sanitari Parc Tauli

    Sabadell, 08208
    Spain

    Site Not Available

  • Skane University Hospital

    Lund, 22185
    Sweden

    Site Not Available

  • Uppsala University

    Uppsala, 75321
    Sweden

    Site Not Available

  • NHS Greater Glasgow and Clyde

    Glasgow, G12 0XH
    United Kingdom

    Site Not Available

  • South London and Maudsley NHS Foundation Trust of The Maudsley Hospital

    London, SE5 8AZ
    United Kingdom

    Site Not Available

  • Greater Manchester Mental Health NHSFT

    Manchester, M25 3BL
    United Kingdom

    Site Not Available

  • Warneford Hospital, NIHR Clinical Research Facility

    Oxford, OX7 3JX
    United Kingdom

    Site Not Available

  • Southwest Autism Research and Resource Center

    Phoenix, Arizona 85006
    United States

    Site Not Available

  • Advanced Research Center Inc

    Anaheim, California 92805
    United States

    Site Not Available

  • University of California at San Diego

    San Diego, California 92103-8620
    United States

    Site Not Available

  • Yale University

    New Haven, Connecticut 06520
    United States

    Site Not Available

  • Children's National Medical Center

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • Sarkis Clinical Trials

    Gainesville, Florida 32607
    United States

    Site Not Available

  • Segal Trials

    Lauderhill, Florida 33319
    United States

    Site Not Available

  • APG Research LLC

    Orlando, Florida 32803
    United States

    Site Not Available

  • APG Research, LLC

    Orlando, Florida 32803
    United States

    Active - Recruiting

  • Ann & Robert H. Lurie Children's Hospital of Chicago

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Baber Research Group

    Naperville, Illinois 60563
    United States

    Site Not Available

  • Beacon Medical Group Clinical Research

    South Bend, Indiana 46601
    United States

    Site Not Available

  • Manhattan Behavioral Medicine

    New York, New York 10036
    United States

    Site Not Available

  • University of Cincinnati Medical Center

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • CincyScience

    West Chester, Ohio 45069
    United States

    Site Not Available

  • Vanderbilt University

    Nashville, Tennessee 37212
    United States

    Site Not Available

  • University of Texas Southwestern Medical Center

    Dallas, Texas 75247
    United States

    Site Not Available

  • Family Psychiatry of The Woodlands

    The Woodlands, Texas 77381
    United States

    Site Not Available

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