Status:
COMPLETED
A Study to Describe Routine Treatment Pathways in Participants With Major Depression and Active Suicidal Ideation With Intent in Italy
Lead Sponsor:
Janssen-Cilag S.p.A.
Conditions:
Depressive Disorder, Major
Suicidal Ideation
Eligibility:
All Genders
18-74 years
Brief 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 (...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 23 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 8 2021
Estimated Enrollment :
136 Patients enrolled
Trial Details
Trial ID
NCT04463108
Start Date
June 23 2020
End Date
November 8 2021
Last Update
April 27 2025
Active Locations (24)
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1
ASST Spedali Civili Brescia
Brescia, Italy, 25123
2
Ospedale Santissima Trinità
Cagliari, Italy, 00000
3
Ospedale Sant'Antonio Abate
Cantù, Italy, 22063
4
Ospedale Vittorio Emanuele
Catania, Italy, 95124