UMIN-CTR Clinical Trial

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