Clinical Trials Logo
  1. Home
  2. Depressive Disorder, Major
  3. NCT04951609

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

Depressive Disorder, Major Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04951609
Study type Interventional
Source Janssen Research & Development, LLC
Contact
Status Terminated
Phase Phase 1
Start date September 2, 2021
Completion date April 8, 2024
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05915013 - Alpha-Amino-3-Hydroxy-5-Methyl-4- Isoxazole Propionic Acid Receptor Components of the Anti-Depressant Ketamine Response Phase 1
Completed NCT04469322 - Pharmacogenetic Implementation Trial in Veterans With Treatment Refractory Depression N/A
Recruiting NCT05415397 - Treating Immuno-metabolic Depression With Anti-inflammatory Drugs Phase 3
Recruiting NCT05988333 - Psychoeducational Intervention for Families With a Member Affected by Major Depression N/A
Completed NCT02919501 - Study of the Efficacy and Safety of Initial Administration of 17 mg Vortioxetine Intravenously With 10 mg/Day Vortioxetine Orally in Patients With Major Depressive Disorder Phase 2
Completed NCT00976560 - Clinical Study to Test a New Drug to Treat Major Depression Phase 2
Recruiting NCT05518149 - A Study of Aticaprant in Adult and Elderly Participants With Major Depressive Disorder (MDD) Phase 3
Not yet recruiting NCT06303076 - Tizanidine vs. Zolpidem in Primary Insomnia: A Randomized Trial Phase 4
Not yet recruiting NCT05901571 - Acupuncture and Escitalopram for Treating Major Depression Clinical Study N/A
Suspended NCT02546024 - Predictors of Treatment Response in Late-onset Major Depressive Disorder N/A
Completed NCT02452892 - Low Field Magnetic Stimulation (LFMS) in Subjects With Treatment-Resistant Depression (TRD) N/A
Completed NCT01583400 - Enhanced Collaborative Depression Treatment in Primary Care: The RESPECT-D-E Trial N/A
Completed NCT01407575 - Buprenorphine for Treatment Resistant Depression Phase 3
Completed NCT01152996 - Safety and Tolerability of Vortioxetine (LuAA21004) - Open Label Extension Study Phase 3
Enrolling by invitation NCT00762866 - Psychiatric Genotype/Phenotype Project Repository
Completed NCT00384033 - Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) In The Treatment Of Major Depressive Disorder Phase 3
Completed NCT00366652 - Study Evaluating the Effects of DVS SR and Duloxetine on the Pharmacokinetics of Desipramine in Healthy Subjects Phase 3
Completed NCT00369343 - Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) Versus Placebo in Peri- and Postmenopausal Women Phase 3
Completed NCT00316160 - Sexual Functioning Study With Antidepressants Phase 4
Completed NCT00149643 - Effectiveness of Fluoxetine in Young People for the Treatment of Major Depression and Marijuana Dependence Phase 2