UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059572 |
|---|---|
| Receipt number | R000068108 |
| Scientific Title | The Study on the Pathophysiology of Psychiatric Symptoms Induced by Antibodies against Neurotransmission-related Molecules |
| Date of disclosure of the study information | 2025/10/29 |
| Last modified on | 2025/10/28 20:25:34 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The Study on the Pathophysiology of Psychiatric Symptoms Induced by Antibodies against Neurotransmission-related Molecules
Acronym
The Study on the Pathophysiology of Psychiatric Symptoms Induced by Antibodies against Neurotransmission-related Molecules
Scientific Title
The Study on the Pathophysiology of Psychiatric Symptoms Induced by Antibodies against Neurotransmission-related Molecules
Scientific Title:Acronym
The Study on the Pathophysiology of Psychiatric Symptoms Induced by Antibodies against Neurotransmission-related Molecules
Region
| Japan |
Condition
Condition
Schizophrenia, First-Episode Psychosis (FEP), At-Risk Mental State (ARMS), Healthy Control
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Recent studies have suggested that autoantibodies against neurotransmission-related molecules may contribute to the development of psychiatric symptoms. For example, anti-NMDA receptor encephalitis is known to cause a variety of psychiatric manifestations, including schizophrenia-like hallucinations and delusions, through autoantibodies targeting NMDA-type glutamate receptors. Furthermore, autoantibodies against synaptic molecules such as neurexin1 and NCAM1 have been detected in a subset of patients with schizophrenia, suggesting that autoimmune mechanisms may underlie a certain proportion of psychotic disorders. The present study aims to measure antibodies against NMDA receptors and other neurotransmission-related molecules in blood samples from patients with schizophrenia, first-episode psychosis, and at-risk mental states, and to elucidate the relationships between antibody status, biological characteristics, clinical symptoms, and cognitive function.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Autoantibodies against neurotransmission-related molecules in blood
Examinations will be conducted five times in principle (at baseline, 6 months, 1 year, 2 years, and 5 years).
Key secondary outcomes
1. Biological Examinations
Brain MRI
Resting-state EEG
Event-related potentials (P300, mismatch negativity)
auditory steady state response (ASSR)
Erythrocyte membrane fatty acid composition
Advanced glycation end products (AGEs)
2. Clinical and Cognitive Assessments
Comprehensive Assessment of At-Risk Mental States (CAARMS)
Positive and Negative Syndrome Scale (PANSS)
Brief Assessment of Cognition in Schizophrenia (BACS)
Schizophrenia Cognition Rating Scale (SCoRS)
Global Assessment of Functioning (GAF)
Social and Occupational Functioning Assessment Scale (SOFAS)
Quality of Life Scale (QLS)
3. Clinical Information
Educational and occupational history
Date of first visit and duration of outpatient treatment
Comorbid psychiatric disorders
Treatment history (medications and duration of administration)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 12 | years-old | <= |
Age-upper limit
| 50 | 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 sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Yuko |
| Middle name | |
| Last name | Higuchi |
Organization
Graduate School of Medicine and Pharmaceutical Sciences,University of Toyama
Division name
Department of Neuropsychiatry
Zip code
9300194
Address
2630 Sugitani Toyama, Japan
TEL
0764347323
yhiguchi@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | Yuko |
| Middle name | |
| Last name | Higuchi |
Organization
Graduate School of Medicine and Pharmaceutical Sciences,University of Toyama
Division name
Department of Neuropsychiatry
Zip code
9300194
Address
2630 Sugitani Toyama, Japan
TEL
0764347323
Homepage URL
yhiguchi@med.u-toyama.ac.jp
Sponsor or person
Institute
University of Toyama
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, University of Toyama Hospital
Address
2630 Sugitani, Toyama 930-0194, Japan
Tel
076-434-2315
rinri@adm.u-toyama.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study includes patients with schizophrenia, first-episode psychosis, or at-risk mental states who are receiving care at the University of Toyama Hospital, as well as healthy controls recruited through the university website, etc. After obtaining informed consent, blood sampling and examinations will be conducted five times (baseline, 6 months, 1, 2, and 5 years). Plasma will be frozen, stored and labeled with research IDs, and sent to the Institute of Science Tokyo for blood analysis. Data from participants in the "Clinical EEG Study of Spontaneous EEG and Auditory Steady-State Responses (R2022060)" and "Genetic Analysis of Psychotic Disorders (I2013006)" studies with secondary-use consent will be analyzed after public disclosure.
Management information
Registered date
| 2025 | Year | 10 | Month | 28 | Day |
Last modified on
| 2025 | Year | 10 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068108
