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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000014717
Receipt No. R000017106
Scientific Title Investigation for the relationships between treatment resistant psychiatric patients and anti-NMDA receptor antibody encephalitis.
Date of disclosure of the study information 2014/08/01
Last modified on 2017/08/04

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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
Middle name
Last name Yuhei Chiba
Organization Yokohama city university hospital
Division name Department of psychiatry
Zip code
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
Middle name
Last name Yuhei Chiba
Organization Yokohama city university hospital
Division name Department of psychiatry
Zip code
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
Address
Tel
Email

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
Anticipated trial start date
2014 Year 08 Month 01 Day
Last follow-up date
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
2017 Year 08 Month 04 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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