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

  • STATUS
    Recruiting
  • End date
    May 29, 2023
  • participants needed
    400
  • sponsor
    Janssen Research & Development, LLC
Updated on 15 January 2022

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).

Details
Condition Depressive Disorder, Major
Treatment Standard of Care (SOC)
Clinical Study IdentifierNCT05109195
SponsorJanssen Research & Development, LLC
Last Modified on15 January 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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/m^2), (inclusive)

Exclusion Criteria

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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