UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study on the effect of transcranial direct current stimulation on cognitive impairment in schizophrenia
Title of the study (Brief title)	The effect of transcranial direct current stimulation in schizophrenia
Region	Japan

Condition
Condition	schizophrenia
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To determine the effect of tDCS on cognitive function and depressive symptoms in patients with schizophrenia
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Brief Assessment of Cognitive function in Schizophrenia Japanese version
Key secondary outcomes	CDSS(Calgary Depression Scale for Schizophrenics) PANSS(Positive and Negative Syndrome Scale)

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	transcranial direct current stimulation (twice daily for 5 days)
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	60 years-old >
Gender	Male and Female
Key inclusion criteria	(1)Meeting DSM-5 criteria for shiczophrenia (2)Able to understand the purposes and nature of the study and provide consetnt to agree to participate in it
Key exclusion criteria	(1)Having severe organic brain regions, head trauma with consciousness loss lasting more than 10 minutues, and/or present or past history of epilepsy (2) Having alcohol or other substances abuse (excluding caffeine and nicotine) witnin 12 months of the baseline assessment (3)Contra-indicated to ECT or tDCS (e.g. history of brain injury) (4) Unqualified to the study based on the investigator's judgment
Target sample size	30

Research contact person
Name of lead principal investigator	Tomiki Sumiyoshi
Organization	National Center of Neurology and Psychiatry
Division name	Translational Medical Center
Address	4-1-1- Ogawahigashi, Kodaira, Tokyo 187-8551 Japan
TEL	+81-42-341-2711
Email	sumiyot@ncnp.go.jp

Public contact
Name of contact person	Kazuko Iwase
Organization	National Center of Neurology and Psychiatry
Division name	Translational Medical Center
Address	4-1-1- Ogawahigashi, Kodaira, Tokyo 187-8551 Japan
TEL	+81-42-341-2711
Homepage URL
Email	iwase@ncnp.go.jp

Sponsor
Institute	National Center of Neurology and Psychiatry
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Japanese Society of the Promotion of Sciences
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	YES
Study ID_1	A2014-100
Org. issuing International ID_1	National Center of Neurology and Psychiatry
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	2015 Year 12 Month 15 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2014 Year 11 Month 28 Day
Anticipated trial start date	2015 Year 01 Month 05 Day
Last follow-up date	2017 Year 12 Month 31 Day
Date of closure to data entry	2018 Year 03 Month 01 Day
Date trial data considered complete	2018 Year 03 Month 15 Day
Date analysis concluded	2018 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 12 Month 15 Day
Last modified on	2016 Year 06 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018556