A Study to Describe Routine Treatment Pathways in Participants With Major Depression and Active S… (NCT04463108) | Clinical Trial Compass
CompletedNot Applicable
A Study to Describe Routine Treatment Pathways in Participants With Major Depression and Active Suicidal Ideation With Intent in Italy
Italy136 participantsStarted 2020-06-23
Plain-language 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.
Who can participate
Age range18 Years – 74 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 curre…
What they're measuring
1
Type of Comprehensive Treatment for Major Depression Disorder (MDD) and Active Suicidal Ideation with Intent
Timeframe: Up to 90 days
2
Number of Psychiatric Drugs
Timeframe: Up to 90 days
3
Duration of Treatment
Timeframe: Up to 90 days
4
Sequence of Treatments in Participants with MDD and Suicidal Ideation with Intent