Prospective Observational Study of the Relationship Between Sociodemographic Factors, Blood-based Biomarkers and Psychiatric Symptoms in Neurodegenerative Diseases and Mental Disorders

N/AEnrolling By InvitationNCT07239843

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau1,310 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,310

Conditions

Major Depressive Disorder (MDD)Schizophenia Disorder Bipolar 1 Disorder Alzheimer Disease Parkinson Disease Frontotemporal Dementia (FTD)

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Age\>18 and donation of blood, * full clinical and psychological assessment * Available neuroimaging is optional as not all patients are suitable. * Age and sex-matched unaffected volunteers without a MD or ND diagnosis are used as controls. * Unaffected controls are usually spouses or children of patients that are informed about our studies at each clinical site. Exclusion Criteria: * Lack of neuropsychological data, * anticoagulant treatment such as acenocoumarol, heparin, warfarin, dabigatran, rivaroxaban, apixaban, drug abuse in the last year, * medical history of cancer affecting the central nervous system that has not been in complete remission for 5 years or longer, * the patient has received potentially neurotoxic chemotherapy and/or patient has received cranial radiotherapy. * Clinical diagnosis of Alzheimer's disease where pathophysiological markers (measured in CSF or plasma) are inconsistent with Alzheimer's disease pathophysiology. * Cognitively healthy volunteers where pathophysiological markers (measured in CSF or plasma) are consistent with Alzheimer's disease or other neurodegenerative pathophysiology.

Outcomes

Primary Outcomes

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).