A Study to Describe Routine Treatment Pathways in Participants With Major Depression and Active Suicidal Ideation With Intent in Italy
NCT ID: NCT04463108
Last Updated: 2025-04-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
136 participants
OBSERVATIONAL
2020-06-23
2021-11-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Participants with MDD and Active Suicidal Ideation with Intent
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
74 Years
ALL
No
Sponsors
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Janssen-Cilag S.p.A.
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen-Cilag S.p.A., Italy Clinical Trial
Role: STUDY_DIRECTOR
Janssen-Cilag S.p.A.
Locations
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ASST Spedali Civili Brescia
Brescia, , Italy
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
ASST Fatebenefratelli Sacco
Milan, , Italy
Ospedale Ca Granda - Niguarda
Milan, , Italy
Dipartimento di Salute Mentale
Modena, , Italy
Ospedale S Francesco d Assisi
Oliveto Citra, , Italy
Aou San Luigi Gonzaga
Orbassano, , Italy
Centro Salute Mentale
Padua, , 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
Countries
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References
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Pompili M, Dell'Osso BM, Rosso G, Amore M, Bellomo A, Mautone A, Pilotto E, Ramacciotti S, Scardigli MI, Ascione G, Cipelli R, Sansone C, Simoni L, Adami M, Delmonte D; ARIANNA Study Group. Routine treatment pathways in a cohort of patients with major depression and suicidality in Italy: the ARIANNA observational study. Compr Psychiatry. 2023 Nov;127:152430. doi: 10.1016/j.comppsych.2023.152430. Epub 2023 Oct 13.
Other Identifiers
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54135419MDD4002
Identifier Type: OTHER
Identifier Source: secondary_id
CR108760
Identifier Type: -
Identifier Source: org_study_id
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