UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024953 |
|---|---|
| Receipt number | R000028710 |
| 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) |
| Date of disclosure of the study information | 2017/01/01 |
| Last modified on | 2019/11/26 21:35:45 |
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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
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
hotaka.shinzato@gmail.com
Sponsor or person
Institute
Department of Neuropsychiatry,Graduate School of Medicine, University of the Ryukyus, Okinawa, Japan
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028710
