Improving health care for people with major depressive disorder
Improving Health Care in Major Depressive Disorder: a New Prognostic Tool Based on Gene Environment and Neuroimaging Signatures
This study is trying to improve care for people with major depressive disorder by finding different groups of patients based on their genetics and brain scans to see how these groups relate to their health outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30900 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Ospedale San Raffaele Academic / other |
| Locations | 1 site (Milano) |
| Trial ID | NCT05816018 on ClinicalTrials.gov |
What this trial studies
This project aims to enhance health care for individuals suffering from major depressive disorder (MDD), a leading cause of disability globally. It utilizes a large cohort of 29,400 individuals with MDD to develop a clustering algorithm that identifies homogeneous subgroups based on genetic, environmental, and brain imaging predictors. The study will link these subgroups to important health outcomes, including disease recurrence, severity, and the risk of comorbidities. Validation of these subgroups will be conducted using an independent sample of 1,380 participants to ensure clinical relevance and accuracy.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 18 to 65 who have been diagnosed with major depressive disorder and have experienced at least one prior depressive episode.
Not a fit: Patients with bipolar disorder, psychotic disorders, or those with substance use issues in the last six months may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective treatment strategies for patients with major depressive disorder.
How similar studies have performed: Other studies have shown promise in using clustering algorithms to identify subgroups in mental health conditions, suggesting a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Milano
- Benedetta Vai — Milano, Italy (Recruiting)
Study contacts
- Principal investigator: Benedetta Vai, PhD — IRCCS San Raffaele Scientific Insititute
- Study coordinator: Benedetta Vai, PhD
- Email: vai.benedetta@hsr.it
- Phone: +393335652025
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.