UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015953 |
|---|---|
| Receipt number | R000018556 |
| Scientific Title | A study on the effect of transcranial direct current stimulation on cognitive impairment in schizophrenia |
| Date of disclosure of the study information | 2015/12/15 |
| Last modified on | 2016/06/15 17:07:40 |
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Basic information
Public title
A study on the effect of transcranial direct current stimulation on cognitive impairment in schizophrenia
Acronym
The effect of transcranial direct current stimulation in schizophrenia
Scientific Title
A study on the effect of transcranial direct current stimulation on cognitive impairment in schizophrenia
Scientific Title:Acronym
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)
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
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
| 1st name | |
| Middle name | |
| Last name | Tomiki Sumiyoshi |
Organization
National Center of Neurology and Psychiatry
Division name
Translational Medical Center
Zip code
Address
4-1-1- Ogawahigashi, Kodaira, Tokyo 187-8551 Japan
TEL
+81-42-341-2711
sumiyot@ncnp.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuko Iwase |
Organization
National Center of Neurology and Psychiatry
Division name
Translational Medical Center
Zip code
Address
4-1-1- Ogawahigashi, Kodaira, Tokyo 187-8551 Japan
TEL
+81-42-341-2711
Homepage URL
iwase@ncnp.go.jp
Sponsor or person
Institute
National Center of Neurology and Psychiatry
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
Preinitiation
Date of protocol fixation
| 2014 | Year | 11 | Month | 28 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018556
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
