Summary

Eligibility
for people ages 18-74 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

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).

Official Title

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

Keywords

Depressive Disorder, Major Depressive Disorder Depression

Eligibility

You can join if…

Open to people ages 18-74

  • Must have a confirmed diagnosis of Major Depressive Disorder (MDD) with a diagnostic code at least twice in the past year
  • Treatment with an selective serotonin reuptake inhibitor (SSRI)/serotonin-norepinephrine reuptake inhibitor (SNRI) for at least 6 weeks at an adequate dose (per Massachusetts General Hospital-Antidepressant Treatment Response Questionnaire [MGH-ATRQ]) and for no more than a year. Specifically, one of the following in any formulation: SSRIs: citalopram, duloxetine, escitalopram, fluvoxamine, fluoxetine, milnacipran, levomilnacipran, paroxetine, sertraline; SNRIs: venlafaxine, desvenlafaxine, vilazodone, or vortioxetine
  • Currently on a single SSRI/SNRI
  • Current episode of MDD has lasted less than 2 years
  • Has a body mass index (BMI) of 18-37 kilograms per meter square (Kg/m2), (inclusive)

You CAN'T join if...

  • Taking more than one antidepressant (regardless of class) at therapeutic doses (therapeutic doses per MGH-ATRQ). A second antidepressant is allowed to be taken at a lower dose if for sleep or pain management
  • Is currently taking a benzodiazepine at higher doses than the equivalent of 3 milligrams (mg) of lorazepam
  • Any coding of a psychotic disorder in the past 5 years including MDD with psychosis
  • Any coding of borderline personality disorder, bipolar disorder, autism spectrum disorder, intellectual disability, somatoform disorder, or fibromyalgia in the past 5 years
  • Any coding of dementia or mild cognitive impairment in the past 5 years

Locations

  • University of California San Francisco not yet accepting patients
    San Francisco California 94143 United States
  • Mayo Clinic withdrawn
    Rochester Minnesota 55905 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Janssen Research & Development, LLC
Links
To learn how to participate in this trial please click here.
ID
NCT05109195
Study Type
Observational
Last Updated