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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000015046
Receipt No. R000017493
Scientific Title Investigating the changing of quantitative Electroencephalogram (EEG), cognitive and emotional function through using translated Direct Current Stimulation (tDCS) in patients with depression
Date of disclosure of the study information 2014/09/04
Last modified on 2019/01/22

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Basic information
Public title Investigating the changing of quantitative Electroencephalogram (EEG), cognitive and emotional function through using translated Direct Current Stimulation (tDCS) in patients with depression
Acronym The effect of tDCS evaluated by qEEG: CEED-D study
Scientific Title Investigating the changing of quantitative Electroencephalogram (EEG), cognitive and emotional function through using translated Direct Current Stimulation (tDCS) in patients with depression
Scientific Title:Acronym The effect of tDCS evaluated by qEEG: CEED-D study
Region
Japan

Condition
Condition Major depression
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the dysfunctional neural network in patients with depression, we will compare the quantitative EEG data and the result of cognitive and emotional tests which are recorded before and after tDCS, and detect the difference of these two groups.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Quantitative EEG, HAM-D, Wisconsin card sorting test(WCST), Assessing Positive and Negative Affect via Self-Report(PANAS)
Key secondary outcomes MADRS, STAI

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 stimulation for DLPFC using tDCS in patients with depression
Interventions/Control_2 stimulation for MPFC using tDCS in patients with depression
Interventions/Control_3 stimulation for DLPFC using tDCS in normal control
Interventions/Control_4 stimulation for MPFC using tDCS in normal control
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
75 years-old >
Gender Male and Female
Key inclusion criteria 18-75 years of age, who met the DSM-IV
Criteria for Major Depressive Disorder (mild and moderate state).
Key exclusion criteria 1. The subjects who met criteria for bipolar, psychotic disorder, or personality disorders.
2. subjects who suffered from neurodegenerative disorders and cognitive disorder, including Parkinson disease, intradural hematoma, normal pressure hydrocephalus, brain tumor, apoplexy, epilepsy, history of seizures, brain
surgery, or significant head trauma
3. hormone abnormality including hypothyroidism, autoimmune disease, cardiovascular, hematology, nervous system, endcroine, liver, kidney disease with clinical importance
4. subjects who has pace makers, stimulation brain devices, ventriculo-peritoneal shunt, artificial organ
5. subjects who are judged as unsuitable case by medical doctors.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Keiichiro Nishida
Organization Kansai Medical University
Division name Neuropsychiatry
Zip code
Address 10-15 Fumizono-cho, Moriguchi-City, Osaka
TEL +81-6-6992-1001
Email nishidak@takii.kmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Keiichiro Nishida
Organization Kansai Medical University
Division name Nuropsychiatry
Zip code
Address 10-15 Fumizono-cho, Moriguchi-City, Osaka
TEL +81-6-6992-1001
Homepage URL
Email nishidak@takii.kmu.ac.jp

Sponsor
Institute Kansai Medical University
Institute
Department

Funding Source
Organization KAKEN
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
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

Other administrative information
Date of disclosure of the study information
2014 Year 09 Month 04 Day

Related information
URL releasing protocol
Publication of results Partially published

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 No longer recruiting
Date of protocol fixation
2014 Year 07 Month 10 Day
Date of IRB
Anticipated trial start date
2014 Year 09 Month 05 Day
Last follow-up date
2017 Year 09 Month 30 Day
Date of closure to data entry
2018 Year 02 Month 28 Day
Date trial data considered complete
2020 Year 03 Month 31 Day
Date analysis concluded
2021 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2014 Year 09 Month 03 Day
Last modified on
2019 Year 01 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017493

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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