Improving Health Care in Major Depressive Disorder

NCT05816018 | Unknown DMC

• 1 other identifier: GR-2019-12370616
• Study Type: observational
• Target: 30,900
• Locations: 1 country
• Sites: 1

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).

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (1)

• The quality of functioning and well-being

  Assessment at the time of recruitment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Inpatients and outpatients with an ongoing depressive episodes diagnosed accordingly to DSM 5.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ospedale San Raffaele: lead
• Ministry of Health, Italy: collaborator
• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: collaborator

Study Sites (1)

Benedetta Vai

Milan, 20131, Italy

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Benedetta Vai, PhD

  IRCCS San Raffaele Scientific Insititute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Benedetta Vai, PhD

CONTACT

+393335652025; vai.benedetta@hsr.it

Irene Bollettini, PhD

CONTACT

bollettini.irene@hsr.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 14, 2023
• First Posted: April 18, 2023
• Study Start: October 12, 2021
• Primary Completion: June 15, 2025
• Study Completion: June 15, 2025
• Last Updated: April 18, 2023

Record last verified: 2023-04

Locations

IT (1)