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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- 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
- 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
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Synapsing's Multinational Sociodemographic Study
- ClinicalTrials.gov ID
- NCT07239843
- Acronym / sponsor ID
- Synapsing-SD / IIBSP-EPM-2024-176
- 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
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,310 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Collaborators
- University of Ulm, University Of Perugia, University of Eastern Finland, Martin-Luther-Universität Halle-Wittenberg
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 20 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Days
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnosis
Time frame: 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
Time frame: 2-months after enrollment
Total Score on the Perceived Wellbeing and Mental Health section of the survey
Social support
Time frame: 2-months after enrolment
Total score on the Social support section of the sociodemographic survey
Socioeconomic background
Time frame: 2-months after enrollment
Total score on the Socioeconomic background section of the sociodemographic survey
Health behaviour
Time frame: 2-months after enrollment
Total score on the Health behaviour section of the sociodemographic survey
Hamilton Depression Rating Scale
Time frame: 2-months after enrollment
Total score on the Hamilton Depression Rating Scale
Boston Naming Test
Time frame: 2-months after enrollment
Total score on the Boston Naming Test
2 secondary outcomes
Structural brain changes
Time frame: 2 months after enrollment
Synaptic biomarker
Time frame: Blood extracted 2-months after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis (time frame: 2-months after enrollment). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.