Clinical trial NCT04463108: A Study to Describe Routine Treatment Pathways in Participants With Major Depression and Active Suicidal Ideation With Intent in Italy
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depressive Disorder, Major
Suicidal Ideation
Lead sponsor: Janssen-Cilag S.p.A.
Sponsor class: INDUSTRY
First posted: 2020-07-09
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population consists of participants with confirmed Major Depressive Disorder (MDD) and active suicidal ideation with intent as per physician's opinion.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Type of Comprehensive Treatment for Major Depression Disorder (MDD) and Active Suicidal Ideation with Intent
timeFrame: Up to 90 days
measure: Number of Psychiatric Drugs
timeFrame: Up to 90 days
measure: Duration of Treatment
timeFrame: Up to 90 days
measure: Sequence of Treatments in Participants with MDD and Suicidal Ideation with Intent
timeFrame: Up to 90 days
measure: Care Setting
timeFrame: Up to 90 days
Secondary outcomes:
measure: Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
timeFrame: Up to Day 104 (End of Visit)
measure: European Quality of Life (EuroQol) 5-Dimension 5-Level Questionnaire (EQ-5D-5L) scores
timeFrame: Up to Day 104 (End of Visit)
measure: Percentage of participants with AEs and SAEs
timeFrame: Up to Day 104 (End of visit)
measure: Healthcare Resource Utilization
timeFrame: Up to day 104 (End of Visit)
Other outcomes:
measure: Suicidal ideation and behavior as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Score
timeFrame: Up to Day 104 (End of study)
measure: Beck Hopelessness Scale (BHS) Score
timeFrame: Up to Day 104 (End of visit)
measure: Montgomery-Asberg Depression Rating Scale Suicide Ideation: item 10 (MADRS-SI)
timeFrame: Up to Day 104 (End of Visit)
measure: Involvement Evaluation Questionnaire (IEQ)
timeFrame: Up to Day 104 (End of Visit)
Locations:
city: Brescia
country: Italy
facility: ASST Spedali Civili Brescia
city: Cagliari
country: Italy
facility: Ospedale Santissima Trinità
city: Cantu'
country: Italy
facility: Ospedale Sant'Antonio Abate
city: Catania
country: Italy
facility: Ospedale Vittorio Emanuele
city: Colleferro
country: Italy
facility: Ospedale Parodi Delfino
city: Foggia
country: Italy
facility: Ospedali Riuniti Foggia
city: Frattamaggiore
country: Italy
facility: Ospedale San Giovanni di Dio
city: Genova
country: Italy
facility: Azienda Ospedaliera Universitaria San Martino di Genova
city: Lido Di Camaiore
country: Italy
facility: Az. USL 12 di Viareggio Ospedale Versilia
city: Macerata
country: Italy
facility: H.U. Santa Lucía
city: Milano
country: Italy
facility: ASST Fatebenefratelli Sacco
city: Milano
country: Italy
facility: Ospedale Ca Granda - Niguarda
city: Modena
country: Italy
facility: Dipartimento di Salute Mentale
city: Oliveto Citra
country: Italy
facility: Ospedale S Francesco d Assisi
city: Orbassano
country: Italy
facility: Aou San Luigi Gonzaga
city: Padova
country: Italy
facility: Centro Salute Mentale
city: Palermo
country: Italy
facility: AOU Policlinico P.Giaccone
city: Putignano
country: Italy
facility: P.O. Putignano
city: Rimini
country: Italy
facility: Ospedale Infermi Rimini
city: Roma
country: Italy
facility: Azienda Ospedaliera Sant Andrea
city: Teramo
country: Italy
facility: Ospedale G. Mazzini
city: Torino
country: Italy
facility: A.O.U. Città della Salute e della Scienza
city: Udine
country: Italy
facility: Azienda Sanitaria Universitaria Integrata di Udine
city: Vicenza
country: Italy
facility: Azienda Ulss 8 Berica- Ospedale Di Vicenza
Study officials:
affiliation: Janssen-Cilag S.p.A.
name: Janssen-Cilag S.p.A., Italy Clinical Trial
role: STUDY_DIRECTOR
References: