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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033334
Receipt No. R000037977
Official scientific title of the study Different forms of prefrontal transcranial stimulation and brain-derived neurotrophic factor in prediction of antidepressant efficacy of brain stimulation
Date of disclosure of the study information 2018/07/09
Last modified on 2018/07/09

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Basic information
Official scientific title of the study Different forms of prefrontal transcranial stimulation and brain-derived neurotrophic factor in prediction of antidepressant efficacy of brain stimulation
Title of the study (Brief title) Brain-derived neurotrophic factor and the antidepressant efficacy of prefrontal transcranial stimulation
Region
Asia(except Japan)

Condition
Condition A treatment option for Medication-resistant depression
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 We will investigate the interaction between BDNF genotype and the efficacy of brain stimulation(10Hz rTMS, iTBS, and sham stimulation) in treating medication-resistant major depression.
Basic objectives2 Others
Basic objectives -Others We further evaluate whether the history of depression refractoriness and the RECT-modulated frontal theta power may predict the antidepressant efficacy of TBS or TMS monotherapy and the before-and-after changing of PET/MRI.
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes the interaction between the efficacy of brain stimulation and BDNF genotype.
Key secondary outcomes the changing of HDRS-17 and response rate (week-4 vs. baseline) after treating by 4-week prefrontal brain stimulation;Response rate; Computerized rACC-engaging cognitive task(RECT)and EEG; Maudsley Staging method for refractoriness;the changing of HDRS-17 and response rate of the 12-week follow-up after the treatment (week-16 vs. baseline) after treating by 4-week brain stimulation; Young mania Rating scale; Clinical Global Index; Depression and somatic symptoms; Life stress scale; functional changing of PET/MRI after prefrontal transcranial stimulation; the comparison between 5 cm rule and neuro-navigation for localization.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Left DLPFC intermittent TBS group (1 session/day, 5 days/week,4weeks); 80% active motor threshold, 1800 pulses once
Interventions/Control_2 Left DLPFC 10Hz rTMS group (1 session/day, 5 days/week,4weeks); 100% motor threshold,1600 pulses once
Interventions/Control_3 Sham group(1 session/day, 5 days/week,4weeks)
randomly divided to half with TBS and half with rTMS parameters using a sham coil.
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
21 years-old <=
Age-upper limit
70 years-old >=
Gender Male and Female
Key inclusion criteria adult patients with the relapse of major depressive episode
Key exclusion criteria Patients with schizophrenia, organic mental disorder, and major physical illness; with brain implants or cardiac pacemakers; pregnancy; or who having strong suicidal risk; contraindication for MRI evaluation.
Target sample size 120

Research contact person
Name of lead principal investigator Cheng-Ta Li
Organization Taipei Veterans General Hospital, Taiwan
Division name Psychiatry
Address No.201, Sec. 2, Shih-Pai Road, Beitou district, Taipei, Taiwan
TEL +88628757027
Email on5083@msn.com

Public contact
Name of contact person Cheng-Ta Li
Organization Taipei Veterans General Hospital, Taiwan
Division name Taipei Veterans General Hospital, Taiwan
Address No.201, Sec. 2, Shih-Pai Road, Beitou district, Taipei, Taiwan
TEL +88628757027
Homepage URL
Email on5083@msn.com

Sponsor
Institute Taipei Veterans General Hospital, Taiwan
Institute
Department

Funding Source
Organization Taipei Veterans General Hospital, Taiwan
Organization
Division
Category of Funding Organization Outside Japan
Nationality of Funding Organization Taiwan, ROC

Other related organizations
Co-sponsor
Name of secondary funder(s)

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
2018 Year 07 Month 09 Day

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2018 Year 06 Month 07 Day
Anticipated trial start date
2018 Year 07 Month 09 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 07 Month 09 Day
Last modified on
2018 Year 07 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037977

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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