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 Type
OBSERVATIONAL
Enrollment
136
No intervention will be administered as a part of this study. Both retrospective and prospective data will be collected. The retrospective data will be collected through medical chart review.
ASST Spedali Civili Brescia
Brescia, Italy
Type of Comprehensive Treatment for Major Depression Disorder (MDD) and Active Suicidal Ideation with Intent
Type of comprehensive treatment for MDD and active suicidal ideation with intent (for example, psychopharmacotherapy; psychosocial treatment; somatic therapy) will be reported.
Time frame: Up to 90 days
Number of Psychiatric Drugs
Number of psychiatric drugs (that is, polypsychopharmacy versus monotherapy) will be reported.
Time frame: Up to 90 days
Duration of Treatment
Duration of treatment for MDD and suicidal ideation with intent will be evaluated.
Time frame: Up to 90 days
Sequence of Treatments in Participants with MDD and Suicidal Ideation with Intent
Treatment sequences for participants with MDD and suicidal ideation with intent (for exapmple, administration of first-line antidepressant) will be assessed.
Time frame: Up to 90 days
Care Setting
Care setting (that is, in-patient and out-patient) will be assessed.
Time frame: Up to 90 days
Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
The MADRS is a clinician-rated scale designed to measure changes in depression severity due to antidepressant treatment.The MADRS consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms) for a total possible score of 60. Higher scores represent a more severe condition.
Time frame: Up to Day 104 (End of Visit)
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Ospedale Santissima Trinità
Cagliari, Italy
Ospedale Sant'Antonio Abate
Cantù, Italy
Ospedale Vittorio Emanuele
Catania, Italy
Ospedale Parodi Delfino
Colleferro, Italy
Ospedali Riuniti Foggia
Foggia, Italy
Ospedale San Giovanni di Dio
Frattamaggiore, Italy
Azienda Ospedaliera Universitaria San Martino di Genova
Genova, Italy
Az. USL 12 di Viareggio Ospedale Versilia
Lido di Camaiore, Italy
H.U. Santa Lucía
Macerata, Italy
...and 14 more locations
European Quality of Life (EuroQol) 5-Dimension 5-Level Questionnaire (EQ-5D-5L) scores
The EQ-5D-5L is a generic measure of health status. The EQ-5D-5L is a 5-item questionnaire that assesses 5 domains including mobility, self-care, usual activities, pain/discomfort and anxiety/depression plus a visual analog scale rating "health today" with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state).
Time frame: Up to Day 104 (End of Visit)
Percentage of participants with AEs and SAEs
An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. A Serious (AE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time frame: Up to Day 104 (End of visit)
Healthcare Resource Utilization
Health Care Resource Utilization (HCRU) will be measured through the number of hospitalization visits, visits to the emergency department, inpatient hospitalization, specialist outpatient visits, number of day care visits, laboratory tests, instrumental and other diagnostic tests related to MDD with active suicidal ideation with intent.
Time frame: Up to day 104 (End of Visit)