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A Study to Describe Routine Treatment Pathways in Participants With Major Depression and Active Suicidal Ideation With Intent in Italy

A Study to Describe Routine Treatment Pathways in Participants With Major Depression and Active Suicidal Ideation With Intent in Italy

Recruiting
18-74 years
All
Phase N/A

Overview

The purpose of the study is to describe the pharmacological and non-pharmacological treatment utilization pathways in Italian routine clinical practice of participants with Major Depressive Disorder (MDD) and active suicidal ideation with intent.

Eligibility

Inclusion Criteria:

  • Participant must meet Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-5) diagnostic criteria for single episode or recurrent Major Depressive Disorder (MDD), based upon clinical assessment
  • In the physician's opinion the current depressive episode is moderate-to-severe in terms of severity.
  • In the physician's opinion, acute psychiatric hospitalization is clinically warranted due to participant's current active suicidal ideation with intent
  • Participant must be capable of discernment
  • Participant must be able to read and write in the Italian language
  • Participant must have signed the informed consent form (ICF) indicating that he/she understands the study purpose and is willing to participate in the study
  • Participant is in the site's catchment area, as evaluated by the Investigator

Exclusion criteria:

  • Participant currently (that is, at the time of enrolment and based upon clinical assessment) meets DSM-5 criteria for psychotic disorder, bipolar or related disorders, antisocial personality disorder, borderline personality disorder, intellectual disability, autism spectrum disorder, dementia
  • Participant meets the DSM-5 severity criteria for moderate or severe substance or alcohol use disorder (except for nicotine or caffeine) within the 6 months before enrolment, based upon clinical assessment
  • Participant has participated in or is currently enrolled in any clinical trial with experimental treatments within the current major depressive episode

Study details
    Suicidal Ideation
    Major depression
    Suicide
    Suicide

NCT04463108

Janssen-Cilag S.p.A.

5 August 2020

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