UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014717
Receipt number 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 2020/08/04 12:13:28

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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 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 or person

Institute

Yokohama city university hospital

Institute

Department

Personal name



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

Value
https://center6.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