UMIN-CTR Clinical Trial

Basic information
Public title	Examination of effectiveness on maintenance of continuing treatment and treatment effect in treatment of refractory mood disorder of transcranial direct current stimulation (tDCS)
Acronym	transcranial direct current stimulation open traial
Scientific Title	Examination of effectiveness on maintenance of continuing treatment and treatment effect in treatment of refractory mood disorder of transcranial direct current stimulation (tDCS)
Scientific Title:Acronym	transcranial direct current stimulation open traial
Region	Japan

Condition
Condition	Mood disorder
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Examine the effectiveness of treatment for mood disorder in tDCS treatment.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluate the remission rate of depression 1 month, 3 months, 6 months, 1 year after treatment start.
Key secondary outcomes	Remission maintenance rate one year after the start of treatment, each item of neuropsychological examination and various biological indicators, changes in various brain function images

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	TDCS treatment is performed from once a week to once a month for one year. I plan to stimulate 1-2 mA for 20-30 minutes.
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	16 years-old <=
Age-upper limit	65 years-old >
Gender	Male and Female
Key inclusion criteria	1,Patient in a mood disorder with intractable depressive symptoms during visit to the psychiatry department affiliated hospital of the University of the Ryukyus 2,Age 16 years older, under 65 years old 3,In the past,used more than two kinds of antidepressants (treatment amount on the package insert) and a sufficient period (4 weeks or more) but in Montgomery - Asberg Depression Scale (MADRS) more than 20 4,Persons whose disease duration is one year or more 5,Regarding participation in this research, a person who gained written consent by the patient's free will and consent was obtained by the substitute.
Key exclusion criteria	1,person with a history of head trauma accompanied by consciousness disturbance of 5 minutes or more 2,Persons who have a history of organic diseases in the brain 3,Person who has history of substance dependence or present symptom 4,Persons who have a history of confusion conscious convulsions 5,Persons who have a history of chronic headache 6,Pregnant or potential women
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Middle name Last name Tsuyoshi Kondo
Organization	Graduate School of Medicine, University of the Ryukyus, Okinawa, Japan
Division name	Department of Neuropsychiatry
Zip code
Address	Uehara 207 Nishihara-Town Okinawa Prefecture
TEL	098-895-1419
Email	psy@w3.u-ryukyu.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Hotaka Shinzato
Organization	Graduate School of Medicine, University of the Ryukyus, Okinawa, Japan
Division name	Department of Neuropsychiatry
Zip code
Address	Uehara 207 Nishihara-Town Okinawa Prefecture
TEL	098-895-1419
Homepage URL
Email	hotaka.shinzato@gmail.com

Sponsor
Institute	Department of Neuropsychiatry,Graduate School of Medicine, University of the Ryukyus, Okinawa, Japan
Institute
Department

Funding Source
Organization	self funding
Organization
Division
Category of Funding Organization	Self funding
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	琉球大学医学部附属病院（沖縄県）

Other administrative information
Date of disclosure of the study information	2017 Year 01 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	Terminated
Date of protocol fixation	2017 Year 01 Month 01 Day
Date of IRB	2016 Year 09 Month 17 Day
Anticipated trial start date	2017 Year 01 Month 01 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry	2019 Year 03 Month 31 Day
Date trial data considered complete	2019 Year 03 Month 31 Day
Date analysis concluded	2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2016 Year 11 Month 22 Day
Last modified on	2019 Year 11 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028710