Neuropsychiatric SymptomDIAMONDNCT07791212
Dissecting Immunological and Autoimmune Mechanisms of Neuropsychiatric Diseases
An observational study of Neuropsychiatric Symptom, run by King's College London at 2 sites in United Kingdom.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 16 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Neuropsychiatric Symptom
- How many people
- 300 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 1 Oct 2026to 1 Oct 2036
- 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 16 to 100 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Participants with neuropsychiatric symptoms aged 16-100 will be recruited through participating clinical services, while control participants may be recruited through clinical services, research databases, social media, local research networks, and advertisements at collaborating universities and NHS sites.
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom2 sites
South London and Maudsley NHS Foundation Trust
London, SE5 8AB
King's College Hospital
London, SE5 9RS
About this study
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.
- Conditions
- Neuropsychiatric Symptom
- Keywords
- Neuropsychiatric Symptom, Neuroimmunology, Inflammation, Autoantibody, Autoimmune Encephalitis, Psychosis, LGI1, NMDAR, Catatonia, Lupus, Antipsychotic
- Medical subject headings
- Inflammation, Autoimmune Diseases of the Nervous System, Psychotic Disorders, Catatonia
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 |
|---|---|---|
| Participants with neuropsychiatric symptoms | Not described | |
| Control Participants | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuronal Autoantibodies
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.
Measured: From enrolment through to 1 year of follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Oct 2036 (estimated)
- Study completion1 Oct 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropsychiatric SymptomStudies of the same condition, open and under way.
- More trials run by King's College LondonThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- South London and Maudsley NHS Foundation Trust, Francis Crick Institute, King's College Hospital NHS Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07791212
- Sponsor's protocol ID
- 354922
- Acronym
- DIAMOND
- Status last verified
- Aug 2026
- First submitted
- 24 Aug 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dissecting Immunological and Autoimmune Mechanisms of Neuropsychiatric Diseases
- ClinicalTrials.gov ID
- NCT07791212
- Acronym / sponsor ID
- DIAMOND / 354922
- Conditions
- Neuropsychiatric Symptom
- Keywords
- Neuropsychiatric Symptom, Neuroimmunology, Inflammation, Autoantibody, Autoimmune Encephalitis, Psychosis, LGI1, NMDAR
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- South London and Maudsley NHS Foundation Trust, Francis Crick Institute, King's College Hospital NHS Trust
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Oct 2036 (estimated)
- Study completion
- 1 Oct 2036 (estimated)
- First posted
- 27 Aug 2026 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants with neuropsychiatric symptoms | – | – |
| Control Participants | – | – |
Who may qualify
- Ages
- 16 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants with neuropsychiatric symptoms aged 16-100 will be recruited through participating clinical services, while control participants may be recruited through clinical services, research databases, social media, local research networks, and advertisements at collaborating universities and NHS sites.
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (11 listed)
- Unacceptable risk of harm to participant or study staff due to risk of behavioural disturbance.
- Inability to have blood tests.
- 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.
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
Neuronal Autoantibodies
Time frame: From enrolment through to 1 year of follow-up.
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.
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 27 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuropsychiatric Symptom, run by King's College London at 2 sites in United Kingdom.
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 9 inclusion and 11 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: opening soon, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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?
Neuronal Autoantibodies (time frame: From enrolment through to 1 year of follow-up.). 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 27 Aug 2026; AzTrials last refreshed its copy on 8 Nov 2026.