42847922MDD1016- A study for adolescent with depression
Research type
Research Study
Full 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 an SSRI and Psychotherapy
IRAS ID
301803
Contact name
David Wright
Contact email
Sponsor organisation
Janssen-Cilag International NV
Eudract number
2021-000567-77
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 4 months, 28 days
Research summary
This is a Phase 1, multicentre, double-blind, randomised, placebo-controlled study to assess the safety, tolerability, and pharmacokinetics of seltorexant (the study drug) in adolescents (patients aged 12 to <18 years) who have a diagnosis of Major Depressive Disorder (MDD) without psychotic features, and who have had an inadequate response to a selective serotonin reuptake inhibitor (SSRI, a standard treatment for MDD) and psychotherapy in the current depressive episode.
Seltorexant (also called JNJ-42847922) is a potent and selective antagonist of the human orexin-2 receptor (OX2R), a type of protein in the human brain known as G protein-coupled receptors (GCPRs). GCPRs regulate almost all the ways in which components of the body work together to sustain life. OX2R mutations are linked with numerous disorders, including depression. Seltorexant is being developed for the treatment of insomnia disorder and adjunctive (i.e. supplementary) treatment of major depressive disorder (MDD) with insomnia symptoms (MDDIS).
Participants who meet the inclusion criteria will be randomised to receive either seltorexant or a placebo as an adjunctive treatment to their standard care of an SSRI (and psychotherapy, if treatment has already been initiated and is ongoing). The study consists of a Screening Phase, a Treatment Phase, and a Follow-up Phase. The Treatment Phase is double-blind, meaning that neither participants or the study teams will know whether they are receiving the study drug or a placebo.
All participants aged under 16-years at the point of screening will require consent from parent(s)/guardian(s), and will be asked to provide assent if able to do so.
REC name
London - Riverside Research Ethics Committee
REC reference
21/LO/0621
Date of REC Opinion
15 Nov 2021
REC opinion
Further Information Favourable Opinion