An observational study in Major Depressive Disorder (MDD), Schizophenia Disorder and Bipolar 1 Disorder, sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau. Enrolling by invitation at 1 site in Spain. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-24.
Sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Observational
This is a prospective observational study to identify sociodemographic factors that predict mental health outcomes in the European population and provide evidence linking common, modifiable sociodemographic risk factors for psychiatric symptoms with biological changes in patients suffering from a mental disorder (MD) or a neurodegenerative disease (ND).
Sociodemographic studies in mental disorder (MD) and neurodegenerative diseases (ND). Sociodemographic factors increase the likelihood of developing an MD and contribute to poorer outcomes. There is less research on socioeconomic differences in ND, but also low socioeconomic status is also associated with dementia risk and early onset dementia. Substantial gaps remain in understanding the social and biological mechanisms underlying these disparities. Effective public health interventions to reduce the burden of these disorders are currently lacking.
2,741 studies on the registry are indexed under Depressive Disorder, Major; 558 are open to participants now.
This study's planned enrollment of 1,310 is above the median of 140 across 357 observational studies indexed under Depressive Disorder, Major.
Browse Depressive Disorder, Major studies →Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau is the lead sponsor of 335 studies on the registry; 64 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients will be recruited from specialized clinics at Barcelona (Spain), Perugia (Italy), Ulm (Germany), Halle (Germany) and Kuopio (Finland). Target % female in schizophrenia (30%), major depressive disorder (50%), bipolar disorder and controls (55%), Alzheimer's disease and controls (60%), frontotemporal dementia (65%), controls (65%). These percentages match those typically found in these disorders. Unaffected controls are usually spouses or children of patients that are informed about our studies at each clinical site. This study also includes participants from a wider European population of people with a lived experience of mental health issues from six focus countries of Europe, UK, Spain, Germany, Finland, Italy and Ireland.
Exclusion Criteria:
Clinical diagnosis of major depressive disorder
Clinical diagnosis of type I + II Bipolar disorder
Clinical diagnosis of schizophrenia
Clinical diagnosis of Parkinson's disease
Clinical diagnosis of Alzheimer's disease
Clinical diagnosis of dementia with Lewy bodies
No clinical diagnosis of a primary psychiatric disorder or neurodegenerative disease
Diagnosis
Primary diagnosis following evaluation by clinician and neuropsychologist or information relating to a previous or current MD/ND diagnosis or mental health issue (Anxiety disorders, behavioural and emotional disorder in children, bipolar affective disorders, depression, dissociation and dissociative disorders, eating disorders, obsessive compulsive disorder, paranoia, post-traumatic stress disorder or psychosis).
Time frame: 2-months after enrollment
Perceived Wellbeing and Mental Health
Total Score on the Perceived Wellbeing and Mental Health section of the survey
Time frame: 2-months after enrollment
Social support
Total score on the Social support section of the sociodemographic survey
Time frame: 2-months after enrolment
Socioeconomic background
Total score on the Socioeconomic background section of the sociodemographic survey
Time frame: 2-months after enrollment
Health behaviour
Total score on the Health behaviour section of the sociodemographic survey
Time frame: 2-months after enrollment
Hamilton Depression Rating Scale
Total score on the Hamilton Depression Rating Scale
Time frame: 2-months after enrollment
Boston Naming Test
Total score on the Boston Naming Test
Time frame: 2-months after enrollment
Structural brain changes
Acquisition of 3T-MRI with a high-resolution 3D T1-weighted anatomical image, a multi-shell diffusion-weighted MRI, and a resting-state functional sequence.
Time frame: 2 months after enrollment
Synaptic biomarker
Plasma concentration of (e.g., NPTX2) measured in plasma
Time frame: Blood extracted 2-months after enrollment
Plan to share: No
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Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau