UMIN-CTR Clinical Trial

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

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

Objectives
Narrative objectives1	This randomized controlled trial aims to evaluate the effect of transcranial direct current stimulation on functional aspects in patients with schizophrenia.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Scores on the UCSD Performance-based Skills Assessment-Brief one month later from the last tDCS administration
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Intensity: 2 mA Frequency:twice daily for 5 consecutive days Duration:20 minute/stimulation
Interventions/Control_2	sham-stimulation
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	70 years-old >
Gender	Male and Female
Key inclusion criteria	Meeting DSM-5 criteria for schizophrenia
Key exclusion criteria	Alcohol or substance disorder Traumatic brain injury Epilepsy
Target sample size	50

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
TEL	0423412711
Email	sumiyot@ncnp.go.jp

Public contact
Name of contact person	Kazuki Sueyoshi
Organization	National Ctr Neurol Psychiatr
Division name	Translational Medical Center
Address	4-1-1, Ogawahigashi, Kodaira, Tokyo
TEL	0423412711
Homepage URL
Email	sueyosi@ncnp.go.jp

Sponsor
Institute	National Center of Neurology and Psychiatry
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
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	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	2017 Year 07 Month 13 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 11 Month 15 Day
Anticipated trial start date	2017 Year 01 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2017 Year 07 Month 13 Day
Last modified on	2017 Year 07 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032305