UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031387
Receipt number R000035836
Scientific Title Cohort study of associations between gamma oscillation and inflammatory response with schizophrenia, major depressive disorder, bipolar disorder.
Date of disclosure of the study information 2018/03/01
Last modified on 2022/10/28 12:04:20

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Basic information

Public title

Cohort study of associations between gamma oscillation and inflammatory response with schizophrenia, major depressive disorder, bipolar disorder.

Acronym

Cohort study of associations between gamma oscillation and inflammatory response with schizophrenia, major depressive disorder, bipolar disorder.

Scientific Title

Cohort study of associations between gamma oscillation and inflammatory response with schizophrenia, major depressive disorder, bipolar disorder.

Scientific Title:Acronym

Cohort study of associations between gamma oscillation and inflammatory response with schizophrenia, major depressive disorder, bipolar disorder.

Region

Japan


Condition

Condition

Schizophrenia, Major depressive disorder,Bipolar disorder

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate association between gamma oscillation and inflammatory response with psychiatric disorder.

Basic objectives2

Others

Basic objectives -Others

To elucidate pathological conditions.

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Power and synchronization of alpha/beta/gamma band oscillation from each electrode.
IL-1 beta,IL-6,IL-10,IGF-beta,TNF-alpha,C4
Psychiatric symptoms:PANSS,GAF,MINI,MDQ,MADRAS,YMRS
Cognitive function:WAIS-Third edition

Key secondary outcomes



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

20 years-old <=

Age-upper limit

60 years-old >

Gender

Male and Female

Key inclusion criteria

Schizophrenia, Major Depressive Disorder, Bipolar Disorder (Diagnosed by DSM-5 or ICD-10).
A right-handed person(by Edinburgh Handedness Inventry).
verval IQ>75.

Key exclusion criteria

History of electro-convulsive therapy, inflammatory disorder such as cancer/infection/autoimmune disorder.
Smoker.
Antipsychotic drug use.
Anti-inflammatory drug use.
Obesity (BMI>25).

Target sample size

216


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takuro Matsubara

Organization

Matsubara Hospital

Division name

Department of Psychiatry

Zip code


Address

4-3-5 Ishibiki, Kanazawa, Ishikawa, Japan

TEL

076-231-4138

Email

kanamatu@bridge.ocn.ne.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takuro Matsubara

Organization

Matsubara Hospital

Division name

Department of Psychiatry

Zip code


Address

4-3-5 Ishibiki, Kanazawa, Ishikawa, Japan

TEL

076-231-4138

Homepage URL


Email

kanamatu@bridge.ocn.ne.jp


Sponsor or person

Institute

Matsubara Hospital

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Kanazawa University Hospital

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

2018 Year 03 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

Completed

Date of protocol fixation

2018 Year 03 Month 01 Day

Date of IRB

2018 Year 03 Month 01 Day

Anticipated trial start date

2018 Year 03 Month 01 Day

Last follow-up date

2022 Year 10 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Cohort study
To evaluate association between gamma oscillation and inflammatory response with psychiatric disorder


Management information

Registered date

2018 Year 02 Month 20 Day

Last modified on

2022 Year 10 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035836


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name