An observational study in Neuropsychiatric Disorders, Neuroinflammatory Disorders and Post-Infectious Neuropsychiatric Disorders, sponsored by National Institute of Mental Health (NIMH). Recruiting at 3 sites in United States. Open to participants aged 1 Month to 100 Years. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by National Institute of Mental Health (NIMH) · Observational
Background:
Some brain or mental health conditions may be caused when a person s immune system attacks their own body. These are called immunologic neuropsychiatric disorders. In this natural history study, researchers want to see if they can find substances in the blood that can help them identify people with this kind of brain or mental illness. What they learn may help them find better ways to diagnose and treat these conditions in the future.
Objective:
To collect blood samples from people with a brain or mental illness that may be related to their immune system.
Eligibility:
People ages 1 month or older with a brain or mental illness that may be related to their immune system.
Design:
Participants will have 1 visit. This visit may be in person or by telehealth. They will answer a questionnaire about their health. They may have blood drawn for testing; this blood sample may also be taken at another medical facility and sent to the researchers.
Researchers will look at the participant s medical records and images over time. Researchers will also collect leftover blood or other tissue samples that are taken in the course of a participant s routine health care.
Participants may opt to have more visits. These visits will be every 3 to 12 months for up to 5 years. They will be asked about changes in their health since their last visit. They may opt to have blood drawn for research.
Study Description:
This study aims to identify and characterize biomarkers in biospecimens collected during clinical care or research encounters, which are not required for clinical or research testing. These "surplus" biospecimens consist of: (1) residual tissue, blood, or CSF remaining after clinical testing is complete; (2) additional blood collected for research purposes at the time of clinical biospecimen collection; (3) residual tissue, blood or CSF collected as part of a human research study; or (4) additional blood collected solely for this research protocol at the same time as biospecimen collection for a separate research protocol from which research blood are already being collected. Additionally, (5) blood will be collected longitudinally from a subset of enrolled participants. Biospecimen categories 1 - 4 do not require an additional venipuncture, whereas 5 does require an additional venipuncture. The biospecimen collection events will occur: (1) at the National Institutes of Health (NIH), (2) at medical centers and academic research institutions, and (3) at commercial phlebotomy facilities in the United States and its affiliated territories. Research activities utilizing the collected biospecimens will occur (1) at the NIH or, after de-identification, in (2) collaborating research laboratories or (3) commercial service facilities. It is anticipated that such studies will yield molecular correlates of and biomarkers for diverse neuropsychiatric illnesses.
Objectives:
The primary objective of this study is to identify immune factors that improve the diagnosis and classification of individuals with suspected immune-associated neuropsychiatric disorders.
The secondary objective is to correlate these immune factors with endotypes and endophenotypes of diverse neuropsychiatric disorders.
Endpoints:
Primary Endpoints:
Secondary Endpoints:
-Derivation and characterization, when feasible, of research grade human monoclonal autoantibodies from biospecimens of participants with candidate or recurrent autoantibody responses, for use in in vitro and ex vivo mechanistic studies.
156 studies on the registry are indexed under Neuroinflammatory Diseases; 73 are open to participants now.
This study's planned enrollment of 5,000 is above the median of 100 across 55 observational studies indexed under Neuroinflammatory Diseases.
Browse Neuroinflammatory Diseases studies →National Institute of Mental Health (NIMH) is the lead sponsor of 367 studies on the registry; 45 are open to participants now.
Of its 25 completed or terminated interventional studies of FDA-regulated products, 24 (96%) have results posted.
Counted across the registry records on this site, refreshed daily.
The study population includes individuals with neuropsychiatric illnesses of possible neuroinflammatory or post-infectious etiology who meet the protocol eligibility criteria. Participants may provide prospectively collected blood biospecimens and associated clinical information, including medical and psychiatric history, neuropsychiatric symptoms, infection history, prior diagnostic testing, and other relevant clinical features. The study may also include existing biospecimens obtained from external sources or repositories, including control biospecimens.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
At the time of enrollment:
To include one or more of the following:
At the time of enrollment participants or surrogates will:
EXCLUSION CRITERIA:
Participant currently under involuntary commitment/hold.
Individuals with neuropsychiatric illnesses of possible neuroinflammatory or post-infectious etiology
Identification of Recurrent Autoantibodies in Neuropsychiatric Subgroups
Identification of autoantibodies that are recurrently detected and statistically enriched (presence versus absence) in prespecified neuropsychiatric diagnostic or phenotypic subgroups compared with control participants.
Time frame: Through study completion, up to 10 years
Correlate these immune factors with endotypes and endophenotypes of diverse neuropsychiatric disorders.
Identification of biomarker signatures that reliably classify psychotic subgroups as distinct from controls.
Time frame: Through study completion, up to 10 years
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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