A Description of Routine Treatment Pathways in a Cohort of Patients With Major Depression and "Active Suicidal Ideation With Intent" in Italy: the Arianna Observational Study.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Janssen-Cilag S.p.A.
- Enrollment
- 136
- Locations
- 24
- Primary Endpoint
- Number of Psychiatric Drugs
Study Overview
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 (MDD) and active suicidal ideation with intent.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 74 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 Criteria
- Not provided
Outcomes
Primary Outcomes
Number of Psychiatric Drugs
Time Frame: Up to 90 days
Number of psychiatric drugs (that is, polypsychopharmacy versus monotherapy) will be reported.
Duration of Treatment
Time Frame: Up to 90 days
Duration of treatment for MDD and suicidal ideation with intent will be evaluated.
Sequence of Treatments in Participants with MDD and Suicidal Ideation with Intent
Time Frame: Up to 90 days
Treatment sequences for participants with MDD and suicidal ideation with intent (for exapmple, administration of first-line antidepressant) will be assessed.
Type of Comprehensive Treatment for Major Depression Disorder (MDD) and Active Suicidal Ideation with Intent
Time Frame: Up to 90 days
Type of comprehensive treatment for MDD and active suicidal ideation with intent (for example, psychopharmacotherapy; psychosocial treatment; somatic therapy) will be reported.
Care Setting
Time Frame: Up to 90 days
Care setting (that is, in-patient and out-patient) will be assessed.
Secondary Outcomes
- Montgomery-Asberg Depression Rating Scale (MADRS) Total Score(Up to Day 104 (End of Visit))
- European Quality of Life (EuroQol) 5-Dimension 5-Level Questionnaire (EQ-5D-5L) scores(Up to Day 104 (End of Visit))
- Healthcare Resource Utilization(Up to day 104 (End of Visit))
- Percentage of participants with AEs and SAEs(Up to Day 104 (End of visit))