UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014048
Receipt number R000016355
Scientific Title Visualization and Qualification of Abnormal Semantic Representation in Schizophrenia
Date of disclosure of the study information 2014/05/23
Last modified on 2022/11/28 10:04:30

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Basic information

Public title

Visualization and Qualification of Abnormal Semantic Representation in Schizophrenia

Acronym

Visualization and Qualification of Abnormal Semantic Representation in Schizophrenia

Scientific Title

Visualization and Qualification of Abnormal Semantic Representation in Schizophrenia

Scientific Title:Acronym

Visualization and Qualification of Abnormal Semantic Representation in Schizophrenia

Region

Japan


Condition

Condition

schizophrenia

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to visualize and quantify semantic representation in the schizophrenia brain using the "semantic representation map", which enables us to do how various words or ideas appear to associate with in the brain. We also aim to investigate the neural basis of thought disorder and its relationship with therapeutic effect in schizophrenia.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

The primary outcome is to evaluate abnormal visual information processing in schizophrenia by comparing cortical activation and semantic representation maps between groups, and investigate the symptomatologic significance using psychological measures.

Key secondary outcomes

The key secondary outcome is to examine the treatment effects by comparing how much the treatments affect above-mentioned parameters.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

We perform functional MRI scanning for healthy group using various movies or psychological tasks as visual stimuli. We investigate its voxelwise relationships with conceptual thesaurus made from the stimuli.

Interventions/Control_2

We perform functional MRI scanning for schizophrenia group using various movies or psychological tasks as visual stimuli. We investigate its voxelwise relationships with conceptual thesaurus made from the stimuli. We evaluate how they change chronologically (about 3-12 months) by clinical therapeutic intervention.

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

16 years-old <=

Age-upper limit

60 years-old >

Gender

Male and Female

Key inclusion criteria

schizophrenia patients with stable symptoms and age-matches healthy controls with no abnormality in central nervous system

Key exclusion criteria

a person under sixteen or from sixty years and up, a person with nervous disease or disease which could affect nervous system regeneration, and a person who is not sufficiently able to agree with due to the condition of disease

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name TAKAHASHI Hidehiko

Organization

Kyoto University Graduate School of Medicine

Division name

Department of Psychiatry

Zip code


Address

54, Shogoin-Kawahara-cho, Sakyo-ku, Kyoto

TEL

075-751-4947

Email

hidehiko@kuhp.kyoto-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name SON Shuraku

Organization

Kyoto University Graduate School of Medicine

Division name

Department of Psychiatry

Zip code


Address

54, Shogoin-Kawahara-cho, Sakyo-ku, Kyoto

TEL

075-751-4947

Homepage URL


Email

a0089374@kuhp.kyoto-u.ac.jp


Sponsor or person

Institute

Kyoto University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Strategic Research Program for Brain Science

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



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 05 Month 23 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

2014 Year 04 Month 09 Day

Date of IRB

2014 Year 06 Month 17 Day

Anticipated trial start date

2014 Year 07 Month 01 Day

Last follow-up date

2017 Year 02 Month 13 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 05 Month 23 Day

Last modified on

2022 Year 11 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016355


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name