Depressive Disorder, MajorARIANNANCT04463108
A Study to Describe Routine Treatment Pathways in Participants With Major Depression and Active Suicidal Ideation With Intent in Italy
An observational study of Depressive Disorder, Major and Suicidal Ideation, run by Janssen-Cilag S.p.A. at 24 sites in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Depressive Disorder, Major, Suicidal Ideation
- How many people
- 136 participants
- Where
- 24 sitesItaly
- Study dates
- 23 Jun 2020to 8 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study population consists of participants with confirmed Major Depressive Disorder (MDD) and active suicidal ideation with intent as per physician's opinion.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
Italy24 sites
ASST Spedali Civili Brescia
Brescia, 25123
Ospedale Santissima Trinità
Cagliari, 00000
Ospedale Sant'Antonio Abate
Cantù, 22063
Ospedale Vittorio Emanuele
Catania, 95124
Ospedale Parodi Delfino
Colleferro, 00034
Ospedali Riuniti Foggia
Foggia, 71122
Ospedale San Giovanni di Dio
Frattamaggiore, 80027
Azienda Ospedaliera Universitaria San Martino di Genova
Genova, 16132
Az. USL 12 di Viareggio Ospedale Versilia
Lido di Camaiore, 53041
ASST Fatebenefratelli Sacco
Milan, 20157
Ospedale Ca Granda - Niguarda
Milan, 20162
Dipartimento di Salute Mentale
Modena, 41126
Ospedale S Francesco d Assisi
Oliveto Citra, 84020
Aou San Luigi Gonzaga
Orbassano, 10043
Centro Salute Mentale
Padova, 35124
AOU Policlinico P.Giaccone
Palermo, 90127
H.U. Santa Lucía
Province of Macerata, 62100
P.O. Putignano
Putignano, 70017
Ospedale Infermi Rimini
Rimini, 47923
Azienda Ospedaliera Sant Andrea
Roma, 00196
Ospedale G. Mazzini
Teramo, 64100
A.O.U. Città della Salute e della Scienza
Torino, 10126
Azienda Sanitaria Universitaria Integrata di Udine
Udine, 33100
Azienda Ulss 8 Berica- Ospedale Di Vicenza
Vicenza, 36100
About this study
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.
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
- Being tested
- No Intervention
- Medical subject headings
- Depressive Disorder, Major, Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 90 days
Number of Psychiatric Drugs
Number of psychiatric drugs (that is, polypsychopharmacy versus monotherapy) will be reported.
Measured: Up to 90 days
Duration of Treatment
Duration of treatment for MDD and suicidal ideation with intent will be evaluated.
Measured: 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.
Measured: Up to 90 days
Care Setting
Care setting (that is, in-patient and out-patient) will be assessed.
Measured: Up to 90 days
Secondary outcomes (4)
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.
Measured: Up to Day 104 (End of Visit)
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).
Measured: Up to Day 104 (End of Visit)
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.
Measured: Up to Day 104 (End of visit)
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.
Measured: Up to day 104 (End of Visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2020
- Study start23 Jun 2020
- Primary completion8 Nov 2021
- Study completion8 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depressive Disorder, MajorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen-Cilag S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen-Cilag S.p.A., Italy Clinical Trial, Study director, Janssen-Cilag S.p.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04463108
- Sponsor's protocol ID
- CR108760
- Other IDs
- 54135419MDD4002
- Acronym
- ARIANNA
- Status last verified
- Apr 2025
- First submitted
- 3 Jul 2020
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37837942
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04463108
- Acronym / sponsor ID
- ARIANNA / CR108760
- Conditions
- Depressive Disorder, Major, Suicidal Ideation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Janssen-Cilag S.p.A.Industry (pharma, biotech, devices)
- Study start
- 23 Jun 2020 (actual)
- Primary completion
- 8 Nov 2021 (actual)
- Study completion
- 8 Nov 2021 (actual)
- First posted
- 9 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with MDD and Active Suicidal Ideation with Intent | – | Other: No InterventionParticipants 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. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population consists of participants with confirmed Major Depressive Disorder (MDD) and active suicidal ideation with intent as per physician's opinion.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No InterventionNo 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. | Other | Participants with MDD and Active Suicidal Ideation with Intent |
Primary outcome
Type of Comprehensive Treatment for Major Depression Disorder (MDD) and Active Suicidal Ideation with Intent
Time frame: 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.
Number of Psychiatric Drugs
Time frame: Up to 90 days
Number of psychiatric drugs (that is, polypsychopharmacy versus monotherapy) will be reported.
Duration of Treatment
Time frame: 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
Time frame: 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.
Care Setting
Time frame: Up to 90 days
Care setting (that is, in-patient and out-patient) will be assessed.
4 secondary outcomes
Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Time frame: Up to Day 104 (End of Visit)
European Quality of Life (EuroQol) 5-Dimension 5-Level Questionnaire (EQ-5D-5L) scores
Time frame: Up to Day 104 (End of Visit)
Percentage of participants with AEs and SAEs
Time frame: Up to Day 104 (End of visit)
Healthcare Resource Utilization
Time frame: Up to day 104 (End of Visit)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Derived from this study: PubMed 37837942Pompili 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen-Cilag S.p.A., Italy Clinical Trial study director
Janssen-Cilag S.p.A.
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depressive Disorder, Major and Suicidal Ideation, run by Janssen-Cilag S.p.A. at 24 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Type of Comprehensive Treatment for Major Depression Disorder (MDD) and Active Suicidal Ideation with Intent (time frame: Up to 90 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04463108, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.