Improving Health Care in Major Depressive Disorder

Recruiting

• Conditions: Major Depressive Disorder

• Registration Number: NCT05816018
• Lead Sponsor: Ospedale San Raffaele

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-12
• Study First Submitted: 2023-03-14
• Status Verified: 2023-04
• Study First Submitted QC: 2023-04-14
• Last Update Submitted: 2023-04-14
• Study First Posted: 2023-04-18
• Last Update Posted: 2023-04-18
• Primary Completion: 2025-06-15
• Study Completion: 2025-06-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30900

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The self-report depressive symptomatology	Assessment at the time of recruitment	Assessment of the depressive characteristics, using the Beck Depression Inventory (BDI) (Beck et al., 1961) with minimum-maximum values 0-39, higher scores mean a worse outcome, regarding the last 2 weeks.
The clinical evaluation of depressive symptomatology	Assessment at the time of recruitment	Assessment of the presence of depressive status, Hamilton Depression Rating Scale (HDRS) (Hamilton, 1967) with minimum-maximum values 0-69, higher scores mean a worse outcome, regarding the current state.
The rate of cardiovascular and/or cardiometabolic diseases	Assessment at the time of recruitment	Assessment of the presence/absence of lifetime and current cardiometabolic and/or cardiovascular diseases (e.g. diabetes, arterial hypertension, pulmonary arterial hypertension) based on extracted data from medical records and chart.
The depressive status	Assessment at the time of recruitment	Assessment of the severity of disease using the Self-report Inventory Of Depressive Symptoms (IDS-SR) (Rush et al., 1996) with minimum-maximum values 0-116, higher scores mean a worse outcome, regarding the last week.

Secondary Outcome Measures

Name	Time	Method
The quality of functioning and well-being	Assessment at the time of recruitment	Assessment of current and lifetime quality of life and well-being using the WHO Quality of Life-BREF (WHOQOL-BREF) (World Health Organization, 1996): the minimum and maximum values are 0-118, higher scores mean a better outcome, regarding the last 2 weeks.

Trial Locations

Locations (1)

Benedetta Vai; 🇮🇹 Milano, Italy