UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009776
Receipt number R000011450
Scientific Title New assessment and neural basis of working memory impairment in schizophrenia
Date of disclosure of the study information 2013/01/21
Last modified on 2017/07/24 10:46:07

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Basic information

Public title

New assessment and neural basis of working memory impairment in schizophrenia

Acronym

Assessment of working memory impairment in schizophrenia

Scientific Title

New assessment and neural basis of working memory impairment in schizophrenia

Scientific Title:Acronym

Assessment of working memory impairment in schizophrenia

Region

Japan


Condition

Condition

schizophrenia

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To develop a new method of assessing working memory impairment in schizophrenia using fMRI

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Association between brain activation and behavioral parameters using new delayed response task focused on central executive system and behavioral indices as below.
PANSS
BACS
CSB
JART-25

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

(1)Twenty patients with schizophrenia according to the DSM-IV criteria recruited from outpatients and inpatients of National Center Hospital, National Center of Neurology and Psychiatry (NCNP). All patients were 20-60 years old and had the capacity to give written informed consent.

(2)Twenty healthy controls aged 20-60 years old without any history of psychiatric and neurological illness, who consented to participate in the study

Key exclusion criteria

(1)Patients with the estimated IQ lower than 80 (by Japanese Adult Reading Test)
(2)Patients with history of organic brain disorder, dementia, pervasive developmental disorder, or substance/alcohol dependence.
(3)Patients with severe irritation that hindered them from being seated still during the experiment.
(4)Patients for whom changes in medication were presumed to be necessary during the study

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazuyoshi Takeda

Organization

National Center Hospital, National Center of Neurology and Psychiatry

Division name

Department of Psychiatry

Zip code


Address

4-1-1, Ogawa-Higashi, Kodaira, Tokyo

TEL

042-341-2711

Email

ktakeda@ncnp.go.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kazuyoshi Takeda

Organization

National Center Hospital, National Center of Neurology and Psychiatry

Division name

Department of Psychiatry

Zip code


Address

4-1-1, Ogawa-Higashi, Kodaira, Tokyo

TEL

042-341-2711

Homepage URL


Email

ktakeda@ncnp.go.jp


Sponsor or person

Institute

National Center of Neurology and Psychiatry

Institute

Department

Personal name



Funding Source

Organization

Ministry of Education, Culture, Sports, Science and Technology

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

国立精神・神経医療研究センター病院(東京都)


Other administrative information

Date of disclosure of the study information

2013 Year 01 Month 21 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

2012 Year 12 Month 15 Day

Date of IRB


Anticipated trial start date

2013 Year 02 Month 01 Day

Last follow-up date

2018 Year 07 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Part of the data of patients with schizophrenia obtained in this study would be used as pre-training data in the intervention study of the cognitive remediation therapy in schizophrenia.


Management information

Registered date

2013 Year 01 Month 14 Day

Last modified on

2017 Year 07 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011450


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name