Depressive Disorder, Major, Suicidal Ideation
Conditions
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.
Interventions
OTHERNo 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.
Sponsors
Janssen-Cilag S.p.A.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 74 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sequence of Treatments in Participants with MDD and Suicidal Ideation with Intent | 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. |
| Number of Psychiatric Drugs | Up to 90 days | Number of psychiatric drugs (that is, polypsychopharmacy versus monotherapy) will be reported. |
| Duration of Treatment | Up to 90 days | Duration of treatment for MDD and suicidal ideation with intent will be evaluated. |
| Type of Comprehensive Treatment for Major Depression Disorder (MDD) and Active Suicidal Ideation with Intent | 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. |
| Care Setting | Up to 90 days | Care setting (that is, in-patient and out-patient) will be assessed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants with AEs and SAEs | Up to Day 104 (End of visit) | 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. |
| Montgomery-Asberg Depression Rating Scale (MADRS) Total Score | Up to Day 104 (End of Visit) | 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. |
| European Quality of Life (EuroQol) 5-Dimension 5-Level Questionnaire (EQ-5D-5L) scores | Up to Day 104 (End of Visit) | 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). |
| Healthcare Resource Utilization | Up to day 104 (End of Visit) | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Suicidal ideation and behavior as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Score | Up to Day 104 (End of study) | 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. |
| Involvement Evaluation Questionnaire (IEQ) | Up to Day 104 (End of Visit) | 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. |
| Montgomery-Asberg Depression Rating Scale Suicide Ideation: item 10 (MADRS-SI) | Up to Day 104 (End of Visit) | 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. |
| Beck Hopelessness Scale (BHS) Score | Up to Day 104 (End of visit) | 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. |
Countries
Italy
Outcome results
None listed