UMIN-CTR Clinical Trial

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 Nishida Middle name Last name Keiichiro
Organization	Kansai Medical University
Division name	Neuropsychiatry
Zip code	570-8506
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 Keiichiro Middle name Last name Nishida
Organization	Kansai Medical University
Division name	Nuropsychiatry
Zip code	570-8506
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	JSPS KAKENHI Grant Number 26860950
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	Kansai Medical University
Address	2-5-1 Shin-machi, Hirakata City, Osaka
Tel	+81-72-804-2325
Email	sangaku@hirakata.kmu.ac.jp

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	2020 Year 09 Month 10 Day

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