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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000020892
Receipt No. R000024104
Scientific Title Antidepressant Efficacy of Prefrontal Transcranial Magnetic Stimulation Monotherapy in Non-drug-responsive Major Depression: a Randomized Case-control Study
Date of disclosure of the study information 2016/02/04
Last modified on 2018/07/09

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Basic information
Public title Antidepressant Efficacy of Prefrontal Transcranial Magnetic Stimulation Monotherapy in Non-drug-responsive Major Depression: a Randomized Case-control Study
Acronym Direct comparisons of antidepressant effects between rTMS and iTBS
Scientific Title Antidepressant Efficacy of Prefrontal Transcranial Magnetic Stimulation Monotherapy in Non-drug-responsive Major Depression: a Randomized Case-control Study
Scientific Title:Acronym Direct comparisons of antidepressant effects between rTMS and iTBS
Region
Asia(except Japan)

Condition
Condition A treatment option for Medication-resistant depression
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We will investigate and compare the efficacy among left prefrontal iTBS, 10 Hz rTMS and sham stimulation in the treatment of major depressive patients.
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.
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes the changing of HDRS-17 (week-2 vs. baseline) in response to the 2-week prefrontal brain stimulation
Key secondary outcomes Computerized rACC-engaging cognitive tasj(RECT); EEG; Maudsley Staging method for refractoriness; response rate; the changing of HDRS-17 of the 12-week follow-up after the treatment (week-14 vs. baseline) in response to the 2-week brain stimulation; Young mania Rating scale; Clinical Global Index; Depression and somatic symptoms; Life stress scale; the comparison for localization between" 5 cm rule" and MRI neuro-navigation.

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,2weeks); 80% active motor threshold, 1800 pulses once
Interventions/Control_2 Left DLPFC 10Hz rTMS group (1 session/day, 5 days/week,2weeks); 100% motor threshold,1600 pulses once
Interventions/Control_3 Sham group(1 session/day, 5 days/week,2weeks)
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
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Cheng-Ta Li
Organization Taipei Veterans General Hospital, Taiwan
Division name Psychiatry
Zip code
Address No.201, Sec. 2, Shih-Pai Road, Beitou district, Taipei, Taiwan
TEL +88628757027
Email on5083@msn.com

Public contact
Name of contact person
1st name
Middle name
Last name Cheng-Ta Li
Organization Taipei Veterans General Hospital, Taiwan
Division name Psychiatry
Zip code
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)

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
2016 Year 02 Month 04 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 Open public recruiting
Date of protocol fixation
2015 Year 03 Month 17 Day
Date of IRB
Anticipated trial start date
2016 Year 02 Month 05 Day
Last follow-up date
2018 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 02 Month 04 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=R000024104

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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