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

NCT04463108 | Completed

• 2 other identifiers: CR10876054135419MDD4002
• Study Type: observational
• Target: 136
• Locations: 1 country
• Sites: 24

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.

Conditions

Depressive Disorder, Major; Suicidal Ideation

Outcome Measures

Primary Outcomes (5)

• 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

• Number of Psychiatric Drugs

  Number of psychiatric drugs (that is, polypsychopharmacy versus monotherapy) will be reported.

  Up to 90 days

• Duration of Treatment

  Duration of treatment for MDD and suicidal ideation with intent will be evaluated.

  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.

  Up to 90 days

• Care Setting

  Care setting (that is, in-patient and out-patient) will be assessed.

  Up to 90 days

Secondary Outcomes (4)

• Montgomery-Asberg Depression Rating Scale (MADRS) Total Score

  Up to Day 104 (End of Visit)

• European Quality of Life (EuroQol) 5-Dimension 5-Level Questionnaire (EQ-5D-5L) scores

  Up to Day 104 (End of Visit)

• Percentage of participants with AEs and SAEs

  Up to Day 104 (End of visit)

• Healthcare Resource Utilization

  Up to day 104 (End of Visit)

Other Outcomes (4)

• Suicidal ideation and behavior as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Score

  Up to Day 104 (End of study)

• Beck Hopelessness Scale (BHS) Score

  Up to Day 104 (End of visit)

• Montgomery-Asberg Depression Rating Scale Suicide Ideation: item 10 (MADRS-SI)

  Up to Day 104 (End of Visit)

Study Arms (1)

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.

Other: No Intervention

Interventions

No Intervention OTHER

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.

Participants with MDD and Active Suicidal Ideation with Intent

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen-Cilag S.p.A.: lead

Study Sites (24)

ASST Spedali Civili Brescia

Brescia, 25123, Italy

Location

Ospedale Santissima Trinità

Cagliari, 00000, Italy

Location

Ospedale Sant'Antonio Abate

Cantù, 22063, Italy

Location

Ospedale Vittorio Emanuele

Catania, 95124, Italy

Location

Ospedale Parodi Delfino

Colleferro, 00034, Italy

Location

Ospedali Riuniti Foggia

Foggia, 71122, Italy

Location

Ospedale San Giovanni di Dio

Frattamaggiore, 80027, Italy

Location

Azienda Ospedaliera Universitaria San Martino di Genova

Genova, 16132, Italy

Location

Az. USL 12 di Viareggio Ospedale Versilia

Lido di Camaiore, 53041, Italy

Location

H.U. Santa Lucía

Macerata, 62100, Italy

Location

ASST Fatebenefratelli Sacco

Milan, 20157, Italy

Location

Ospedale Ca Granda - Niguarda

Milan, 20162, Italy

Location

Dipartimento di Salute Mentale

Modena, 41126, Italy

Location

Ospedale S Francesco d Assisi

Oliveto Citra, 84020, Italy

Location

Aou San Luigi Gonzaga

Orbassano, 10043, Italy

Location

Centro Salute Mentale

Padua, 35124, Italy

Location

AOU Policlinico P.Giaccone

Palermo, 90127, Italy

Location

P.O. Putignano

Putignano, 70017, Italy

Location

Ospedale Infermi Rimini

Rimini, 47923, Italy

Location

Azienda Ospedaliera Sant Andrea

Roma, 00196, Italy

Location

Ospedale G. Mazzini

Teramo, 64100, Italy

Location

A.O.U. Città della Salute e della Scienza

Torino, 10126, Italy

Location

Azienda Sanitaria Universitaria Integrata di Udine

Udine, 33100, Italy

Location

Azienda Ulss 8 Berica- Ospedale Di Vicenza

Vicenza, 36100, Italy

Location

Related Publications (1)

• 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.

  PMID: 37837942 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Suicidal Ideation

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Janssen-Cilag S.p.A., Italy Clinical Trial

  Janssen-Cilag S.p.A.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2020
• First Posted: July 9, 2020
• Study Start: June 23, 2020
• Primary Completion: November 8, 2021
• Study Completion: November 8, 2021
• Last Updated: April 27, 2025

Record last verified: 2025-04

Locations

IT (24)