UMIN-CTR Clinical Trial

Basic information
Public title	Investigation for the relationships between treatment resistant psychiatric patients and anti-NMDA receptor antibody encephalitis.
Acronym	Investigation for the relationships between treatment resistant psychiatric patients and anti-NMDA receptor antibody encephalitis.
Scientific Title	Investigation for the relationships between treatment resistant psychiatric patients and anti-NMDA receptor antibody encephalitis.
Scientific Title:Acronym	Investigation for the relationships between treatment resistant psychiatric patients and anti-NMDA receptor antibody encephalitis.
Region	Japan

Condition
Condition	Treatment resistant psychiatric disease, anti-NMDA receptor antibody encephalitis
Classification by specialty	Neurology Clinical immunology Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We investigate the antibody titers of anti-NMDA receptor antibody in patients with treatment resistant psychiatric disease. We evaluate the correlation between those and the clinical symptoms, clinical diagnosis, the results of laboratory and imaging examination.
Basic objectives2	Others
Basic objectives -Others	Clinical utility
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Demographic information of the targets are age, gender, psychiatric symptoms, disease duration and psychiatric diagnosis. Clinical symptoms include disturbance of consciousness, convulsions, disorientation, impaired short-term memory, anarithmia, configuration failure, hallucinations, delusions, anxiety, depression, emotional lability, personality change, gait disturbance, bradykinesia, muscular rigidity, tremor and Katatonia. Blood tests include general blood tests, autoantibodies such as TG and TPO antibodies and thyroid function tests (TSH fT3 fT4). Anti-neuronal antibodies are anti-NMDA-NR1 and NR2 antibody. Cerebrospinal fluid tests includes general examination, anti-NMDA-NR1 and NR2 antibody. Imaging and physiological function tests are head MRI examination, head SPECT and EEG. Psychological tests are cognitive function test such as WAIS-III, WMS-R, WCST, MMSE, and HDS-R. Psychiatric evaluation includes PANSS and BPRS. (We use the data that is listed in the medical record) For the normal volunteer, we perform blood tests, head MRI examination and psychological examination. Cerebrospinal fluid examination is performed when the consent was obtained from the volunteer.
Key secondary outcomes	Correlation between the titer of the anti-NMDA receptor antibodies and the clinical symptoms, clinical diagnosis, the results of laboratory and imaging examination.

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Psychiatric patients who did not remitted by the standard more than 2 medications. Normal controls are healthy volunteers.
Key exclusion criteria	Psychiatric patients who were treated by less than 1 standard psychiatric medication.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Yuhei Middle name Last name Chiba
Organization	Yokohama city university hospital
Division name	Department of psychiatry
Zip code	236-0004
Address	3-9, Fukuura, kanazawa-ku, Yokohama-shi
TEL	045-787-2800
Email	suezan_2000@yahoo.co.jp

Public contact
Name of contact person	1st name Yuhei Middle name Last name Chiba
Organization	Yokohama city university hospital
Division name	Department of psychiatry
Zip code	236-0004
Address	3-9, Fukuura, kanazawa-ku, Yokohama-shi
TEL	045-787-2800
Homepage URL
Email	yu_chiba@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama city university hospital
Institute
Department

Funding Source
Organization	Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Yokohama City university Hospital
Address	Fukuura 3-9, Kanazawa-ku, Yokohama-shi, Japan
Tel	+81-45-787-2800
Email	rinri@yokohama-cu.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	2014 Year 08 Month 01 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	Enrolling by invitation
Date of protocol fixation	2014 Year 07 Month 04 Day
Date of IRB	2014 Year 08 Month 01 Day
Anticipated trial start date	2014 Year 08 Month 01 Day
Last follow-up date	2024 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

We investigate the antibody titers of anti-NMDA receptor antibody in the serum and CSF of patients with treatment resistant psychiatric disease. We evaluate the correlation between those and the clinical symptoms, clinical diagnosis, the results of laboratory and imaging examination. This study is a open labeled and prospective study. Invasiveness examinations are blood collection and cerebrospinal fluid collection. For the volunteers, cerebrospinal fluid collection is performed when the consent was obtained.

Management information
Registered date	2014 Year 07 Month 31 Day
Last modified on	2020 Year 08 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017106