- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07791212
Dissecting Immunological and Autoimmune Mechanisms of Neuropsychiatric Diseases (DIAMOND)
The goal of this observational cohort study is to investigate the role of immune system in neuropsychiatric symptoms (NPS) and to identify immunological biomarkers that may improve the diagnosis, prognosis, and future treatment of immune-related neuropsychiatric disorders in individuals aged 16-100 years with suspected immune-mediated neuropsychiatric symptoms and matched control participants without neuropsychiatric symptoms.
The main questions it aims to answer are what immunological mechanisms are associated with neuropsychiatric symptoms across a range of neurological, psychiatric, autoimmune, infectious, and inflammatory conditions. Also, if immunological biomarkers can be identified that may support the diagnosis, prognosis, and future treatment of neuropsychiatric disorders in which the immune system may play a role.
Participants will provide a blood sample for immunological analysis and may optionally provide a cerebrospinal fluid (CSF) sample if a suitable previously collected sample is not available. Researchers may also analyse existing clinical and biological samples where available. Participants will provide demographic and clinical information, allow access to relevant medical record data, and may optionally provide additional blood samples, up to four times within one year, for further biomarker and immunological analyses.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiesteder
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London, Det Forenede Kongerige, SE5 9RS
- King's College Hospital
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London, Det Forenede Kongerige, SE5 8AB
- South London and Maudsley NHS Foundation Trust
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
INCLUSION CRITERIA
Participants with Neuropsychiatric symptoms
- Age 16-100.
- Current or previous neuropsychiatric symptoms within the last year.
- Suspicion of immunological contribution to the aetiology of their neuropsychiatric symptoms.
Control Participants
- Age 16-100.
- No current or previous self-report of neuropsychiatric symptoms within the last year.
Optional Lumbar Puncture only:
- Documented full blood count within the last 3 months with no clinically significant abnormalities.
EXCLUSION CRITERIA
All Participants:
- Unacceptable risk of harm to participant or study staff due to risk of behavioural disturbance.
- Inability to have blood tests.
Optional Lumbar Puncture only:
- Significant lower spinal deformity (such as spina bifida), injury, or disease (such as stenosis) or previous lower spinal surgery.
- Antiplatelet or anticoagulant therapy within the 14 days prior to Lumbar Puncture procedure.
- Known or suspected clotting disorder.
- Clinically significant abnormality in full blood count.
- Known or suspected raised intracranial pressure, assessed by study clinician.
- Known or suspected allergy to local anaesthetic agent or an ingredient of the anaesthetic solution.
- History of chronic or recurrent headaches, in the opinion of the investigator.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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Kontrol deltagere
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Participants with neuropsychiatric symptoms
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Neuronal Autoantibodies
Tidsramme: From enrolment through to 1 year of follow-up.
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Differences in the prevalence, subtype, and functional characteristics of neuronal autoantibodies in serum and cerebrospinal fluid between participants with neuropsychiatric symptoms (NPS) and matched control participants.
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From enrolment through to 1 year of follow-up.
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Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Neurologiske manifestationer
- Sygdomme i nervesystemet
- Skizofrenispektrum og andre psykotiske lidelser
- Psykiske lidelser
- Patologiske processer
- Autoimmune sygdomme
- Sygdomme i immunsystemet
- Adfærdsmæssige symptomer
- Neuroadfærdsmæssige manifestationer
- Patologiske tilstande, tegn og symptomer
- Opførsel
- Tegn og symptomer
- Psykotiske lidelser
- Betændelse
- Catatonia
- Autoimmune sygdomme i nervesystemet
Andre undersøgelses-id-numre
- 354922
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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