Blood biomarkers for immune-related neuropsychiatric conditions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational, longitudinal study that collects biospecimens and health information from participants with neuropsychiatric symptoms that may involve immune or inflammatory mechanisms. Researchers will use surplus clinical biospecimens and may collect additional blood samples to look for molecular biomarkers. Participation involves one visit (in person or via telehealth) plus possible follow-up blood collections for a subset of participants, with data and samples potentially shared with collaborators after de-identification. The aim is to characterize biomarkers that correlate with immune-related neuropsychiatric conditions to improve future diagnosis and treatment approaches.

Why it matters

Who can join: the full rules

* INCLUSION CRITERIA:

At the time of enrollment:

* Participants must be 1 month or above in age.
* Participant biospecimens must be physically located in the United States, or its territories or freely associated states
* Participants must have a neuropsychiatric illness of possible neuroinflammatory, or post-infectious etiology based on clinical report and findings from the referring facility/provider.

To include one or more of the following:

* known or suspected infection or inflammation of the nervous system,
* new-onset post-infectious neuropsychiatric symptoms,
* new or recurrent neuropsychiatric symptoms in the setting of a diagnosed autoimmune disease or proinflammatory disease state (e.g. systemic lupus erythematosus, sarcoidosis, Sjogren s, Down Syndrome),
* new-onset neuropsychiatric symptoms within 5 years of a cancer diagnosis,
* new-onset neuropsychiatric symptoms in the context of immune checkpoint inhibitor therapy,
* new-onset neuropsychiatric symptoms in the setting of a known or clinically supported primary immune deficiency,
* subacute onset psychiatric symptoms with cognitive impairment or personality change defined as a progression from baseline to functionally impaired within 3 months of the onset of symptoms,
* or have a typical psychiatric presentation with neuroimaging, CSF, or laboratory findings suggestive of neuroinflammatory process

At the time of enrollment participants or surrogates will:

* be willing to participate in the protocol s procedures, unless clinically contraindicated,
* provide informed consent, either directly or via an appointed legally authorized representative,
* be willing to consent to secondary use of clinical data and biological samples collected at and prior to the time of their enrollment

EXCLUSION CRITERIA:

Participant currently under involuntary commitment/hold.

Where it's running

• Childrens Hospital, Los Angeles
  Los Angeles, California, United States Recruiting
• National Institutes of Health Clinical Center
  Bethesda, Maryland, United States Recruiting
• Brigham and Women's Hospital
  Boston, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Christopher M Bartley, M.D. — National Institute of Mental Health (NIMH)
• Study coordinator: Margaret J Pekar
• Email: tiu.research@nih.gov
• Phone: (301) 402-1084

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.