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

Janssen (J&J Innovative Medicine)

Status: Completed

Conditions: Suicidal Ideation; Depressive Disorder, Major

Treatments: Other: No Intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT04463108

54135419MDD4002 (Other Identifier)

CR108760

Details and patient eligibility

About

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.

Enrollment: 136 patients

Sex: All

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

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

Trial design

136 participants in 1 patient group

Participants with MDD and Active Suicidal Ideation with Intent

Description:

Participants with Major Depressive Disorder (MDD) and active suicidal ideation with intent as defined/confirmed by Investigator will be enrolled and treated in accordance with routine clinical practice. The primary data source for this study will be the medical records of each participant.

Treatment:

Other: No Intervention