Major Depressive Disorder (MDD)Synapsing-SDNCT07239843
Prospective Observational Study of the Relationship Between Sociodemographic Factors, Blood-based Biomarkers and Psychiatric Symptoms in Neurodegenerative Diseases and Mental Disorders
An observational study of Major Depressive Disorder (MDD) and Schizophenia Disorder, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder (MDD), Schizophenia Disorder, Bipolar 1 Disorder
- How many people
- 1,310 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2026to 30 Dec 2029
- How long will I take part?
- 2 Days
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Synapsing's Multinational Sociodemographic Study
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).
Read the 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.
- Conditions
- Major Depressive Disorder (MDD), Schizophenia Disorder, Bipolar 1 Disorder, Alzheimer Disease, Parkinson Disease, Frontotemporal Dementia (FTD)
- Keywords
- magnetic resonance imaging, sociodemographic, biomarker, plasma, serum, blood
- Medical subject headings
- Depressive Disorder, Major, Alzheimer Disease, Parkinson Disease, Frontotemporal Dementia, Lewy Body Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| major depressive disorder | Clinical diagnosis of major depressive disorder | |
| Bipolar disorder | Clinical diagnosis of type I + II Bipolar disorder | |
| Schizophrenia | Clinical diagnosis of schizophrenia | |
| Parkinson's disease | Clinical diagnosis of Parkinson's disease | |
| Alzheimer's disease | Clinical diagnosis of Alzheimer's disease | |
| Dementia with Lewy bodies | Clinical diagnosis of dementia with Lewy bodies | |
| Unaffected controls | No clinical diagnosis of a primary psychiatric disorder or neurodegenerative disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 2-months after enrollment
Perceived Wellbeing and Mental Health
Total Score on the Perceived Wellbeing and Mental Health section of the survey
Measured: 2-months after enrollment
Social support
Total score on the Social support section of the sociodemographic survey
Measured: 2-months after enrolment
Socioeconomic background
Total score on the Socioeconomic background section of the sociodemographic survey
Measured: 2-months after enrollment
Health behaviour
Total score on the Health behaviour section of the sociodemographic survey
Measured: 2-months after enrollment
Hamilton Depression Rating Scale
Total score on the Hamilton Depression Rating Scale
Measured: 2-months after enrollment
Boston Naming Test
Total score on the Boston Naming Test
Measured: 2-months after enrollment
Secondary outcomes (2)
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.
Measured: 2 months after enrollment
Synaptic biomarker
Plasma concentration of (e.g., NPTX2) measured in plasma
Measured: Blood extracted 2-months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start1 Feb 2026
- Primary completion1 Jun 2026 (estimated)
- Study completion30 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive Disorder (MDD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,310 participants (estimated)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ulm, University Of Perugia, University of Eastern Finland, Martin-Luther-Universität Halle-Wittenberg
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07239843
- Sponsor's protocol ID
- IIBSP-EPM-2024-176
- Acronym
- Synapsing-SD
- Status last verified
- Apr 2026
- First submitted
- 14 Nov 2025
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No