Clinical Trial: The Study on the Pathophysiology of Psychiatric Symptoms Induced by Antibodies against Neurotransmission-related Molecules (Japan)

Tokyo, Oct. 29 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059572) titled 'The Study on the Pathophysiology of Psychiatric Symptoms Induced by Antibodies against Neurotransmission-related Molecules' on Oct. 29.

Study Type: Observational

Primary Sponsor: Institute - University of Toyama

Condition: Condition - Schizophrenia, First-Episode Psychosis (FEP), At-Risk Mental State (ARMS), Healthy Control Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - This study aims to measure autoantibodies against neurotransmission-related molecules, such as NMDA receptors, neurexin1, and NCAM1, in blood samples from patients with schizophrenia, first-episode psychosis, and at-risk mental state (ARMS). Furthermore, the relationships between these autoantibodies and various biological and clinical indicators, including EEG findings, psychiatric symptoms, and cognitive functions, will be analyzed to clarify the mechanisms by which autoantibodies contribute to the development of psychiatric symptoms. Basic objectives2 - Others

Eligibility: Age-lower limit - 12 years-old = Gender - Male and Female Key inclusion criteria - Patients who are currently receiving outpatient or inpatient treatment at the Department of Neuropsychiatry, University of Toyama Hospital, and who meet the diagnostic criteria for schizophrenia (F20) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) or the International Classification of Diseases, 10th Revision (ICD-10) will be included. Individuals identified as being at clinical high risk for psychosis (At-Risk Mental State; ARMS) based on the Comprehensive Assessment of At-Risk Mental States (CAARMS; Yung et al., 2005), a structured interview for assessing risk of psychosis, will also be included. Patients who meet the ICD-10 criteria for Persistent Delusional Disorder (F22), Acute and Transient Psychotic Disorder (F23), or Mood Disorders with Psychotic Features (F32.3, F31.2, F31.5) will be included as first-episode psychosis cases. In addition, healthy control participants without any past or family history of psychiatric disorders will be recruited through the University of Toyama website and related media. Eligible participants will be between 12 and 50 years of age. For adult participants, written informed consent will be obtained from the individual. For minors, in principle, consent will be obtained from both the participant and their parent or guardian. Key exclusion criteria - Participants will be excluded if any of the following apply:

[Healthy Control Group] A history of neurological disease or severe head injury. A history of alcohol or substance abuse within the past five years. Presence of any Axis I psychiatric disorder as determined by the Structured Clinical Interview for DSM Disorders, Non-Patient Edition (SCID-NP), or a first-degree relative (parent, sibling, or child) with an Axis I psychiatric disorder based on participant report.

[Patient Group] Psychiatric symptoms are clearly attributable to delirium, or to alcohol or substance abuse. The researcher determines that the psychiatric condition is unstable and that participation in the study, including examinations or explanations, may cause symptom exacerbation. Target Size - 600

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 10 Month 02 Day Date of IRB - 2025 Year 10 Month 07 Day Anticipated trial start date - 2025 Year 11 Month 05 Day Last follow-up date - 2030 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068108

Disclaimer: Curated by HT Syndication.