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

  • STATUS
    Recruiting
  • participants needed
    220
  • sponsor
    Janssen-Cilag S.p.A.
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Updated on 5 August 2020
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depressive disorder
depressive episode
psychiatric disorder
suicidal
depression
pharmacological treatment
major depressive disorder
mental illness
psychiatric hospitalization
active suicidal ideation

Summary

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.

Details
Condition Suicidal Ideation, Major depression, Suicide, Suicide
Age 18years - 74years
Treatment No intervention
Clinical Study IdentifierNCT04463108
SponsorJanssen-Cilag S.p.A.
Last Modified on5 August 2020

Eligibility

 Yes No Not Sure

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
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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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