A Study to Describe Routine Treatment Pathways in Participants With Major Depression and Active Suicidal Ideation With Intent in Italy
- Conditions
- Depressive Disorder, MajorSuicidal Ideation
- Interventions
- Other: No Intervention
- Registration Number
- NCT04463108
- Lead Sponsor
- Janssen-Cilag S.p.A.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 136
- 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
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Participants with MDD and Active Suicidal Ideation with Intent No Intervention 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.
- Primary Outcome Measures
Name Time Method Number of Psychiatric Drugs Up to 90 days Number of psychiatric drugs (that is, polypsychopharmacy versus monotherapy) will be reported.
Duration of Treatment 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 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 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 Up to 90 days Care setting (that is, in-patient and out-patient) will be assessed.
- Secondary Outcome Measures
Name Time Method Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Up to Day 104 (End of Visit) 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.
European Quality of Life (EuroQol) 5-Dimension 5-Level Questionnaire (EQ-5D-5L) scores Up to Day 104 (End of Visit) 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).
Healthcare Resource Utilization Up to day 104 (End of Visit) 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.
Percentage of participants with AEs and SAEs Up to Day 104 (End of visit) 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.
Trial Locations
- Locations (24)
Ospedale S Francesco d Assisi
🇮🇹Oliveto Citra, Italy
ASST Spedali Civili Brescia
🇮🇹Brescia, Italy
Ospedale Santissima Trinità
🇮🇹Cagliari, Italy
Ospedale Sant'Antonio Abate
🇮🇹Cantu', 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
ASST Fatebenefratelli Sacco
🇮🇹Milano, Italy
Ospedale Ca Granda - Niguarda
🇮🇹Milano, Italy
Dipartimento di Salute Mentale
🇮🇹Modena, Italy
Aou San Luigi Gonzaga
🇮🇹Orbassano, Italy
Centro Salute Mentale
🇮🇹Padova, Italy
AOU Policlinico P.Giaccone
🇮🇹Palermo, Italy
P.O. Putignano
🇮🇹Putignano, Italy
Ospedale Infermi Rimini
🇮🇹Rimini, Italy
Azienda Ospedaliera Sant Andrea
🇮🇹Roma, Italy
Ospedale G. Mazzini
🇮🇹Teramo, Italy
A.O.U. Città della Salute e della Scienza
🇮🇹Torino, Italy
Azienda Sanitaria Universitaria Integrata di Udine
🇮🇹Udine, Italy
Azienda Ulss 8 Berica- Ospedale Di Vicenza
🇮🇹Vicenza, Italy