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

Depressive Disorder, Major Clinical Trial

— ARIANNA  

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04463108
• Other study ID #: CR108760
• Secondary ID: 54135419MDD4002
• Status: Completed
• Start date: June 23, 2020
• Est. completion date: November 8, 2021

Study information

• Verified date: December 2021
• Source: Janssen-Cilag S.p.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: November 8, 2021
• Est. primary completion date: November 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Depressive Disorder
• Depressive Disorder, Major
• Suicidal Ideation

Intervention

Other:
• No Intervention
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.

Locations

Country	Name	City	State
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	Ospedale S. Francesco d'Assisi	Oliveto Citra
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

Sponsors (1)

Lead Sponsor	Collaborator
Janssen-Cilag S.p.A.

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Suicidal ideation and behavior as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Score	Suicidal ideation or behavior will be measured using C-SSRS score. C-SSRS is a clinician rated assessment of suicidal behavior and/ or intent. Scale consists of 28 items in 4 sections: suicide behavior, actual attempts, suicidal ideation, and intensity of ideation. Suicidal ideation consists of 5 yes/no items: wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods (not plan) without intention to act, active suicidal ideation with some intent to act without specific plan, active suicidal ideation with specific plan and intent. Worsening of suicidal ideation will be an increase in severity of suicidal ideation from baseline.	Up to Day 104 (End of study)
Other	Beck Hopelessness Scale (BHS) Score	BHS is paper-based self-reported measure to assess one's level of negative expectations or pessimism regarding future. The scale consists of 20 true-false items that examine the respondent's attitude over past week by either endorsing a pessimistic statement or denying an optimistic statement; 9-items are keyed false and 11 are keyed true. Items fall within 3 domains: feelings about future; loss of motivation; future expectations. Each response is assigned a score of 0 or 1. Total BHS score is sum of item responses, with range from 0 to 20, with a higher score representing higher level of hopelessness. Total scores that range from 0 to 3 are (normal range), scores 4 to 8 (mild hopelessness, scores 9 to 14 (moderate hopelessness), scores <14 (severe hopelessness). Negative change in score indicates improvement.	Up to Day 104 (End of visit)
Other	Montgomery-Asberg Depression Rating Scale Suicide Ideation: item 10 (MADRS-SI)	MADRS is clinician-rated scale designed to measure depression severity, and to detect changes due to antidepressant treatment. MADRS item 10, or MADRS-SI evaluates apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts; scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of symptoms), summed for a total possible score of 0 to 60. Higher scores represent more severe condition.	Up to Day 104 (End of Visit)
Other	Involvement Evaluation Questionnaire (IEQ)	The 31-item Involvement Evaluation Questionnaire measures caregiver burden. It has been validated for caregivers of individuals with schizophrenia, covers a broad domain of caregiving consequences and refers to burden experienced within the past 4 weeks. Mean scores are calculated for the total scale and sub-scales. Total scores can range from 29 to 145 with sub-scale domains ranging - tension, 9-45; supervision, 6-30; worrying, 6-30; and urging, 8-40. Lower total and subscale scores indicate less burden and higher scores greater level of caregiver burden.	Up to Day 104 (End of Visit)
Primary	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.	Up to 90 days
Primary	Number of Psychiatric Drugs	Number of psychiatric drugs (that is, polypsychopharmacy versus monotherapy) will be reported.	Up to 90 days
Primary	Duration of Treatment	Duration of treatment for MDD and suicidal ideation with intent will be evaluated.	Up to 90 days
Primary	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.	Up to 90 days
Primary	Care Setting	Care setting (that is, in-patient and out-patient) will be assessed.	Up to 90 days
Secondary	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.	Up to Day 104 (End of Visit)
Secondary	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).	Up to Day 104 (End of Visit)
Secondary	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.	Up to Day 104 (End of visit)
Secondary	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.	Up to day 104 (End of Visit)