UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037843
Receipt number R000043145
Scientific Title Symptom-based research in psychiatric disorders
Date of disclosure of the study information 2019/10/01
Last modified on 2019/08/29 12:24:37

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Basic information

Public title

Symptom-based research in psychiatric disorders

Acronym

Symptom-based research in psychiatric disorders

Scientific Title

Symptom-based research in psychiatric disorders

Scientific Title:Acronym

Symptom-based research in psychiatric disorders

Region

Japan


Condition

Condition

psychiatric disorders

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

symptom based-approach in psychiatric disorders.

Basic objectives2

Others

Basic objectives -Others

To measure psychiatric symptoms in detail, we apply high resolution MRI, psychological test and assessment for daily activities.

Trial characteristics_1

Others

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

structural and functional alteration using high resolution MRI

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

High resolution MRI

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

18 years-old <=

Age-upper limit

80 years-old >

Gender

Male and Female

Key inclusion criteria

patient with psychiatric symptoms

Key exclusion criteria

Has a contraindication to undergoing MRI

Target sample size

400


Research contact person

Name of lead principal investigator

1st name Naoya
Middle name
Last name Oishi

Organization

Kyoto University

Division name

Graduate School of Medicine, Medical Innovation Center

Zip code

6068507

Address

53 Shogoin-Kawaharacho, Kyoto

TEL

0753667417

Email

noishi@kuhp.kyoto-u.ac.jp


Public contact

Name of contact person

1st name Shiho
Middle name
Last name Ubukata

Organization

Kyoto University

Division name

Graduate School of Medicine, Medical Innovation Center

Zip code

6068507

Address

53 Shogoin-Kawaharacho, Kyoto

TEL

0753667417

Homepage URL


Email

ubukata@kuhp.kyoto-u.ac.jp


Sponsor or person

Institute

Kyoto University, Graduate School of Medicine, Medical Innovation Center

Institute

Department

Personal name



Funding Source

Organization

SHIONOGI & CO., LTD.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kyoto university graduate school and faculty of medicine, Kyoto university hospital ethics committe

Address

Konoecho, Kyoto

Tel

0757534680

Email

ethcom@kuhp.kyoto-u.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

2019 Year 10 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

Preinitiation

Date of protocol fixation

2019 Year 08 Month 28 Day

Date of IRB


Anticipated trial start date

2019 Year 10 Month 01 Day

Last follow-up date

2022 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 08 Month 29 Day

Last modified on

2019 Year 08 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043145


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name