Prospective Observational Study of the Relationship Between Sociodemographic Factors, Blood-based Biomarkers and Psychiatric Symptoms in Neurodegenerative Diseases and Mental Disorders
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Major Depressive Disorder (MDD), Schizophenia Disorder, Bipolar 1 Disorder, Alzheimer Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Synapsing's Multinational Sociodemographic Study
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).
Detailed 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.
Primary outcome measures
- Diagnosis [Time frame: 2-months after enrollment]
- Perceived Wellbeing and Mental Health [Time frame: 2-months after enrollment]
- Social support [Time frame: 2-months after enrolment]
- Socioeconomic background [Time frame: 2-months after enrollment]
- Health behaviour [Time frame: 2-months after enrollment]
- Hamilton Depression Rating Scale [Time frame: 2-months after enrollment]
- Boston Naming Test [Time frame: 2-months after enrollment]
Secondary outcome measures (2)
- Structural brain changes [Time frame: 2 months after enrollment]
- Synaptic biomarker [Time frame: Blood extracted 2-months after enrollment]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
Spain · 1 center
- IRSP — Barcelona
Identifiers
NCT: NCT07239843 · IIBSP-EPM-2024-176