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

  • STATUS
    Recruiting
  • End date
    May 4, 2023
  • participants needed
    52
  • sponsor
    Janssen Research & Development, LLC
Updated on 22 November 2021

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.

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.

Details
Condition Major depression, major depressive disorders
Treatment Placebo, Seltorexant
Clinical Study IdentifierNCT04951609
SponsorJanssen Research & Development, LLC
Last Modified on22 November 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Has inadequate response to at least 1, but no more than 2 antidepressant treatments during the current major depressive episode including their current antidepressant fluoxetine or escitalopram (SSRI). Inadequate response is defined as less than (<) 50 percentage (%) symptom reduction after adequate antidepressant treatment for at least 6 weeks at the minimum therapeutic dose, with at least 4 weeks at the optimal dose prior to screening
Has had at least 6 sessions of psychotherapy in this episode prior to randomization
Must have Children's Depression Rating Scale-Revised (CDRS-R) total score greater than or equal to (>=) 48 at the beginning of screening with no more than a 25% improvement during screening
Participants weighing between fifth and ninety-fifth percentile for age and sex. Obese participants greater than ninety-fifth percentile and underweight participants below fifth percentile may participate following medical clearance, as long as their baseline weight is >=30 kilograms (kg)
A female participant of childbearing potential must have a negative urine pregnancy test at screening and baseline

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 metabolic disturbances. Stable medical conditions are allowed
Has history or current diagnosis of psychotic disorder, bipolar disorder, conduct disorder, intellectual disability, autism spectrum disorder, borderline personality disorder, somatoform disorders, or fibromyalgia
Has a significant primary sleep disorder (example, obstructive sleep apnea, parasomnias) confirmed by polysomnography (PSG) assessment at screening for participants in subgroup, but participants with insomnia or hypersomnia disorders are allowed
At significant risk of committing suicide based on history or according to the investigator'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 3 months or a history of suicidal behavior within the last 6 months
Has known allergies, hypersensitivity, or intolerance to seltorexant or its excipients
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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