Summary

Eligibility
for people ages 12-17 (full criteria)
Location
at San Diego, California and other locations
Dates
study started
estimated completion

Description

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.

Official Title

A Short-term Exploratory Study to Evaluate Safety, Tolerability and Pharmacokinetics of Seltorexant as Adjunctive Therapy to Antidepressants in Adolescents With Major Depressive Disorder Who Have an Inadequate Response to SSRI Monotherapy and Psychotherapy

Details

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.

Keywords

Depressive Disorder, Major Depressive Disorder Depression Seltorexant

Eligibility

You can join if…

Open to people ages 12-17

  • 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

You CAN'T join if...

  • 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

Locations

  • University of California at San Diego not yet accepting patients
    San Diego California 92103-8620 United States
  • Family Psychiatry of The Woodlands accepting new patients
    The Woodlands Texas 77381 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Janssen Research & Development, LLC
ID
NCT04951609
Phase
Phase 1
Study Type
Interventional
Last Updated