UMIN-CTR Clinical Trial

Public title

Different forms of prefrontal transcranial stimulation and brain-derived neurotrophic factor in prediction of antidepressant efficacy of brain stimulation

Acronym

Brain-derived neurotrophic factor and the antidepressant efficacy of prefrontal transcranial stimulation

Scientific Title

Different forms of prefrontal transcranial stimulation and brain-derived neurotrophic factor in prediction of antidepressant efficacy of brain stimulation

Scientific Title:Acronym

Brain-derived neurotrophic factor and the antidepressant efficacy of prefrontal transcranial stimulation

Region

Asia(except Japan)

Condition

A treatment option for Medication-resistant depression

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

YES

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

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.

Study type

Interventional

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

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

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

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

Name of contact person

1st name
Middle name
Last name	Cheng-Ta Li

Organization

Taipei Veterans General Hospital, Taiwan

Division name

Taipei Veterans General Hospital, Taiwan

Zip code

Address

No.201, Sec. 2, Shih-Pai Road, Beitou district, Taipei, Taiwan

TEL

+88628757027

Homepage URL

Email

on5083@msn.com

Institute

Taipei Veterans General Hospital, Taiwan

Institute

Department

Personal name

Organization

Taipei Veterans General Hospital, Taiwan

Organization

Division

Category of Funding Organization

Outside Japan

Nationality of Funding Organization

Taiwan, ROC

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

07

Month

09

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Open public recruiting

Date of protocol fixation

2018

Year

06

Month

07

Day

Date of IRB

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

Other related information

Registered date

2018

Year

07

Month

09

Day

Last modified on

2018

Year

07

Month

09

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037977