Clinical trial NCT05816018: Improving Health Care in Major Depressive Disorder
Official title: Improving Health Care in Major Depressive Disorder: a New Prognostic Tool Based on Gene Environment and Neuroimaging Signatures
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Major Depressive Disorder
Lead sponsor: Ospedale San Raffaele
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Italy
name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
First posted: 2023-04-18
Enrollment: 30900
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inpatients and outpatients with an ongoing depressive episodes diagnosed accordingly to DSM 5.

Brief summary: This project aims to improve the health care provided to people with major depressive disorder (MDD), a disease which is a top cause of disability worldwide. One of the main obstacles to a more effective health care in these patients is represented by clinical heterogeneity, which has not completely elucidated biological correlates. Using a large sample of people with MDD already recruited (n=29,400), the investigators develop a clustering algorithm based on genetic-environmental and brain imaging predictors aimed at identifying homogeneous MDD subgroups. The researchers will then link these subgroups with relevant health outcomes, such as disease recurrency and severity, well-being and functioning, risk of psychiatric and medical comorbidities (e.g. cardiovascular disorders). Replication in independent samples already recruited(n=1380) will prove the validity of the subgroups and expand their clinical characterization. The investigators will develop a classification tool to link the individual's characteristics to the relevant health outcomes and provide corresponding clinical recommendations. The prognostic support tool will be applied to newly recruited samples, feasibility and usefulness according to clinicians's opinion will be assessed (n=120, ongoing recruitment).


Eligibility criteria: Inclusion Criteria:

* diagnosis of depressive episode in Major Depressive Disorder (DSM-5);
* at least one depressive episode preceding the current one;
* aged between 18 and 65;
* score of at least 8 on the Hamilton Depression Rating Scale (HDRS);
* signature of the information form and declaration of informed consent;
* elementary school certificate (as a minimum requirement for understanding the questions presented in the tests);
* native Italian speaker (or bilingualism).

Exclusion Criteria:

* diagnosis of bipolar disorder, cyclothymic disorder, schizophrenia and other psychotic spectrum disorders, neurodevelopmental disorders;
* diagnosis of intellectual disability, epilepsy, neurodegenerative disorders;
* disorders related to the use of drugs or alcohol in the last 6 months (except nicotine and caffeine);
* pregnant or breastfeeding.

Primary outcomes:
measure: The depressive status
timeFrame: Assessment at the time of recruitment
measure: The self-report depressive symptomatology
timeFrame: Assessment at the time of recruitment
measure: The clinical evaluation of depressive symptomatology
timeFrame: Assessment at the time of recruitment
measure: The rate of cardiovascular and/or cardiometabolic diseases
timeFrame: Assessment at the time of recruitment
Secondary outcomes:
measure: The quality of functioning and well-being
timeFrame: Assessment at the time of recruitment
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Benedetta Vai
Study officials:
affiliation: IRCCS San Raffaele Scientific Insititute
name: Benedetta Vai, PhD
role: PRINCIPAL_INVESTIGATOR
References: