Improving Health Care in Major Depressive Disorder

Major Depressive Disorder Clinical Trial

— DepType  

Official title:

Improving Health Care in Major Depressive Disorder: a New Prognostic Tool Based on Gene Environment and Neuroimaging Signatures

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05816018
• Other study ID #: GR-2019-12370616
• Status: Recruiting
• Start date: October 12, 2021
• Est. completion date: June 15, 2025

Study information

• Verified date: April 2023
• Source: Ospedale San Raffaele
• Contact: Benedetta Vai, PhD
• Phone: +393335652025
• Email: vai.benedetta[@]hsr.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30900
• Est. completion date: June 15, 2025
• Est. primary completion date: June 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Locations

Country	Name	City	State
Italy	Benedetta Vai	Milano

Sponsors (3)

Lead Sponsor	Collaborator
Ospedale San Raffaele	Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Ministry of Health, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The depressive status	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.	Assessment at the time of recruitment
Primary	The self-report depressive symptomatology	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.	Assessment at the time of recruitment
Primary	The clinical evaluation of depressive symptomatology	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.	Assessment at the time of recruitment
Primary	The rate of cardiovascular and/or cardiometabolic diseases	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.	Assessment at the time of recruitment
Secondary	The quality of functioning and well-being	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.	Assessment at the time of recruitment