drugset / Trial / 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

NCT04951609 ↗

Phase 1 Terminated 31 enrolled Janssen Research & Development, LLC
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2021-09-02
Primary completion
2024-04-08
Completion
2024-04-08

Outcome

Outcome not reported

Stopped (Business): “Following discussion on pediatric strategy with HAs, it was determined that we have sufficient data to inform next steps for the seltorexant pediatric program.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Seltorexant Small molecule — Oral