NCT05109195

A Standard of Care Study of Patients With Major Depressive Disorder Who Have Had an Inadequate Response to a Selective Serotonin Reuptake/Serotonin-Norepinephrine Reuptake Inhibitor Antidepressant

A Prospective, Observational Standard of Care Study of Patients With Major Depressive Disorder Who Have Had an Inadequate Response to a Selective Serotonin Reuptake /Serotonin-Norepinephrine Reuptake Inhibitor Antidepressant as a Control Arm for the Safety Assessments in the Seltorexant Phase 3 Program

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 7 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the safety (adverse events, serious adverse events, deaths, suicidality) of participants with major depressive disorder (MDD) treated according to the standard of care (SOC).

Conditions

• Depressive Disorder, Major

Interventions

Type	Name	Description
OTHER	Standard of Care (SOC)	Participants will not receive any intervention as a part of this study. Participants will receive SOC treatment.

Timeline

• Start date: 2021-10-26
• Primary completion: 2022-10-19
• Completion: 2022-10-19
• First posted: 2021-11-05
• Last updated: 2025-04-27

Locations

4 sites across 2 countries: United States, United Kingdom

Regulatory

• FDA-regulated drug study