Prospective Observational Study of the Relationship Between Sociodemographic Factors, Blood-based Biomarkers and Psychiatric Symptoms in Neurodegenerative Diseases and Mental Disorders
Major Depressive Disorder (MDD)Schizophenia DisorderBipolar 1 DisorderAlzheimer DiseaseParkinson DiseaseFrontotemporal Dementia (FTD)Dementia With Lewy Bodies (DLB)
Study summary
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).
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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.
Primary outcome measure(s)
Diagnosis — 2-months after enrollment 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).
Perceived Wellbeing and Mental Health — 2-months after enrollment Total Score on the Perceived Wellbeing and Mental Health section of the survey
Social support — 2-months after enrolment Total score on the Social support section of the sociodemographic survey
Socioeconomic background — 2-months after enrollment Total score on the Socioeconomic background section of the sociodemographic survey
Health behaviour — 2-months after enrollment Total score on the Health behaviour section of the sociodemographic survey
Hamilton Depression Rating Scale — 2-months after enrollment Total score on the Hamilton Depression Rating Scale
Boston Naming Test — 2-months after enrollment Total score on the Boston Naming Test
Trial sites (1)
Facility
City
Region
Status
IRSP
Barcelona
Barcelona
More Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau trials in Spain
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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