Recruiting

Observational Study

Sponsor:

National Institute of Mental Health (NIMH)

Code:

NCT07877246

Conditions

Neuropsychiatric Disorders

Neuroinflammatory Disorders

Post-Infectious Neuropsychiatric Disorders

Eligibility Criteria

Sex: All

Age: 0 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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.

Conditions

Neuropsychiatric Disorders

Neuroinflammatory Disorders

Post-Infectious Neuropsychiatric Disorders

Study ID

NCT07877246

Start date

Oct 21, 2026

Status verified date

Sep 30, 2026

Completion date

Sep 30, 2036

Anticipated

Primary completion date

Sep 17, 2036

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 70+

Healthy Volunteers: Not accepted

  • 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.

Study Design

Enrollment

5000 participants

Anticipated

Interventions and Outcome Measures

Arms

Individuals with neuropsychiatric illness

Individuals with neuropsychiatric illnesses of possible neuroinflammatory or post-infectious etiology

Primary outcome measure

  • Identification of Recurrent Autoantibodies in Neuropsychiatric Subgroups [ Time Frame: Through study completion, up to 10 years ]

Central Contacts and Locations

Central contacts

Margaret J Pekar

(301) 402-1084pekarm@mail.nih.gov

Christopher M Bartley, M.D.

(301) 792-5273chris.bartley@nih.gov

Locations

Childrens Hospital, Los Angeles

Recruiting

Los Angeles, California, United States, 90054-0700

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

NIH Clinical Center Office of Patient Recruitment (OPR)

800-411-1222ccopr@nih.gov

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

More Information

Sponsor

National Institute of Mental Health (NIMH)

Last update posted

Oct 16, 2026

Last verified

Sep 30, 2026

Keywords

  • Neuropsychiatric Disorders
  • Neuroinflammation
  • Post-infectious neuropsychiatric disorders
  • Infection-associated neuropsychiatric disorders
  • Neuroimmune disorders
  • Immune-mediated neuropsychiatric disorders
  • Neuropsychiatric symptoms
  • Post-infectious neurological disorders
  • Biospecimens
  • Neuroimmune Biomarkers

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-17. This information was provided to ClinicalTrials.gov by National Institute of Mental Health (NIMH) on 2026-10-16. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.