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

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Status: Invitation-only

Conditions: Schizophenia Disorder; Alzheimer Disease; Dementia With Lewy Bodies (DLB); Bipolar 1 Disorder; Parkinson Disease; Frontotemporal Dementia (FTD); Major Depressive Disorder (MDD)

Study type: Observational

Funder types: Other

Identifiers

NCT07239843

IIBSP-EPM-2024-176

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 1,310 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

1,310 participants in 7 patient groups

major depressive disorder

Description:

Clinical diagnosis of major depressive disorder

Bipolar disorder

Description:

Clinical diagnosis of type I + II Bipolar disorder

Schizophrenia

Description:

Clinical diagnosis of schizophrenia

Parkinson's disease

Description:

Clinical diagnosis of Parkinson's disease

Alzheimer's disease

Description:

Clinical diagnosis of Alzheimer's disease

Dementia with Lewy bodies

Description:

Clinical diagnosis of dementia with Lewy bodies

Unaffected controls

Description:

No clinical diagnosis of a primary psychiatric disorder or neurodegenerative disease