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Collaborative Response for Overlapping Symptoms of Somatic and Mental Illness in Neurological Disorders

Collaborative Response for Overlapping Symptoms of Somatic and Mental Illness in Neurological Disorders

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12625001320448
Acronym
CROSSMIND
Enrollment
200
Registered
2025-11-27
Start date
2026-01-01
Completion date
2030-01-01
Last updated
2025-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study aims to provide comprehensive insights into the clinical course, relapse rate, treatment outcomes, and potential adverse events experienced during immunosuppressive therapy for participants presenting with neuropsychiatric symptoms related to autoimmune or inflammatory processes. The information obtained through this project is intended to provide information to guide clinicians' decision-making process, particularly in relation to selecting appropriate therapeutic approaches for managing these varied and complex neuropsychiatric syndromes. By elucidating the effectiveness and potential risks associated with immunosuppressive therapy in our cohort, we aspire to make a substantial contribution to the enhancement of participant care and the optimization of treatment strategies for this challenging and multifaceted medical condition. Adult participants over the age of 18 with a diagnosis of autoimmune encephalitis made by the treating neurologist/immunologist and who received a trial of immunosuppressive therapy (e.g. corticosteroids, intravenous immunoglobulins, plasmapheresis, cyclophosphamide, rituximab, mycophenolate) will be included in an analysis of clinical data collected from eMR records. Research samples and data will be collected only after participant consent is obtained, up to November 30, 2030. Data will be collected from the Western Sydney Local Health District (WSLHD) eMR and will include information readily available in the clinical notes and letters, discharge and admission summaries, pathology results, or any other forms of documentation available on eMR. Data will be re-identifiable at time of collection but will be de-identified at time of analysis. Blood samples for biobanking for future research will be collected after receiving participant consent, by drawing additional tubes for research purposes during routine blood draws in clinic at Westmead Hospital. This study will be storing participant blood and tissue samples via the SWIFT Biobank: Sydney West Immunology Forum for Translational Research: Clinical Database and Biobank (2019/ETH02568) study, which has ethics approval to establish biobanks for various immunological conditions.

Interventions

At Westmead Hospital, a group of participants presenting with psychiatric symptoms, such as first episode psychosis and/or atypical/treatment resistant schizophrenia, depression, or a combination of psychotic and mood disorder features, were investigated with a subset judged to have an immune contribution to their condition (positive serum and cerebral spinal fluid autoantibodies or other markers of neuroinflammation). These participants underwent immunomodulatory therapy, with standard treatmen

At Westmead Hospital, a group of participants presenting with psychiatric symptoms, such as first episode psychosis and/or atypical/treatment resistant schizophrenia, depression, or a combination of psychotic and mood disorder features, were investigated with a subset judged to have an immune contribution to their condition (positive serum and cerebral spinal fluid autoantibodies or other markers of neuroinflammation). These participants underwent immunomodulatory therapy, with standard treatment associated monitoring at Westmead Hospital. Adult participants over the age of 18 with a diagnosis of autoimmune encephalitis made by the treating neurologist/immunologist and who received a trial of immunosuppressive therapy (e.g. corticosteroids, intravenous immunoglobulins, plasmapheresis, cyclophosphamide, rituximab, mycophenolate) will be included in an analysis of clinical data collected from eMR records. Research samples and data will be collected only after participant consent is obtained, at every visit to site, up to November 30, 2030. The frequency of observation will vary, dependant on how often the participant attends clinical visits as standard of care. Data will only be collected from the Western Sydney Local Health District (WSLHD) eMR and will include information readily available in the clinical notes and letters, discharge and admission summaries, pathology results, or any other forms of documentation available on eMR. Data will be re-identifiable at time of collection but will be de-identified at time of analysis. Blood samples for biobanking for future research will be collected after receiving participant consent, Data variables to be collected and analysed include the following, where questionnaires, tests or procedures have been performed as part of routine standard of care and the data is available in the participant’s eMR. No questionnaires, tests or procedures will be performed for the purpose of this study in addition to routine standard of care. • Demographic information (e.g., date of birth, gender, weight, height) • Medical history and co-morbidities • Neuropsychiatric symptomatology and presentation • Brain imaging (MRI and PET) • Clinical progress • Social and occupational functioning • Autoimmune encephalitis diagnosis and severity • Immunological markers and autoantibodies • Details of immunomodulatory and psychotropic therapy (e.g., type, dosage, duration) • Clinical course and treatment outcomes of autoimmune encephalitis • Occurrence and nature of adverse events, including standardised clinic letters to record adverse events with consistent terminology • Relapse rates and time to relapse

Sponsors

Western Sydney Local Health District
Lead SponsorGovernment body

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

• Adults aged 18 years or over • Documented diagnosis of psychiatric disease • Presenting with psychiatric symptoms, such as first episode psychosis and/or atypical/treatment resistant: a. Schizophrenia b. Depression c. Combination of psychotic and mood disorder features • Documented immune contribution to their condition (as confirmed by positive serum and CSF autoantibodies or other markers of neuroinflammation)

Exclusion criteria

• Under 18 years of age

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026