UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044951
Receipt number R000051350
Scientific Title Antidepressant efficacy of prefrontal theta-burst stimulation on refractory depression: a randomized sham-controlled study combining neuroimaging
Date of disclosure of the study information 2021/07/27
Last modified on 2021/07/25 22:52:20

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Basic information

Public title

Antidepressant efficacy of prefrontal theta-burst stimulation on refractory depression: a randomized sham-controlled study combining neuroimaging

Acronym

prefrontal stimulation and related changes of neuroimaging

Scientific Title

Antidepressant efficacy of prefrontal theta-burst stimulation on refractory depression: a randomized sham-controlled study combining neuroimaging

Scientific Title:Acronym

prefrontal stimulation and related changes of neuroimaging

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 efficacy of brain stimulation(10Hz rTMS, piTBS, 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 and neurocognitive functions performance.

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase IV


Assessment

Primary outcomes

The primary efficacy outcome was improvement in depression, measured by percentage change in HDRS-17 score (% HDRS-17) before and after 2 weeks of brain stimulation treatment between the prolonged intermittent theta-burst stimulation, 10Hz-repetitive transcranial magnetic stimulation, and sham control.

Key secondary outcomes

The changes among three groups(pretreatment vs posttreatment) in (1) response rate (defined as >=50% reduction compared with the baseline HDRS-17 score) and (2) the remission rate (defined as HDRS-17 score <8).(3)Computerized rACC-engaging cognitive task(RECT)and EEG bands (4)functional changes of PET/MRI (5) Neurocognitive tests for attentional performance (TAP) and executive function (Wisconsin card sorting test). (6) TMS-EEG (7) genome-wide association evaluation. (8) DSSS scale, and CGI.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Double blind -all involved are blinded

Control

Active

Stratification

NO

Dynamic allocation


Institution consideration


Blocking

YES

Concealment



Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Left DLPFC prolonged intermittent TBS group (2 session/day, 5 days/week, 2 weeks); 80% active motor threshold, 1800 pulses/session.

Interventions/Control_2

Left DLPFC 10Hz rTMS group (2 session/day, 5 days/week,2-weeks); 120% motor threshold,3000 pulses/session

Interventions/Control_3

Sham group(2 session/day, 5 days/week,2 weeks) 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

15 years-old <=

Age-upper limit

80 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients were qualified (1) if they failed to respond to at least one adequate antidepressant treatment in their current episode. (2) The recruited patients were required to be antidepressant-free for at least 2 weeks prior to this double-blind, sham-controlled trial (if fluoxetine uses, the antidepressant-free period needs to be 4 weeks). (3) Moreover, all recruited participants had to have a Clinical Global Impression-Severity score of at least 4 and a total score of at least 18 on the Hamilton Depression Rating Scale.

Key exclusion criteria

Patients were excluded if (1) they had a lifetime psychiatric history of bipolar disorder, schizophrenia, psychotic disorders, or organic mental disorder including substance abuse and dependence (based on DSM-IV criteria) (2) or probable dementia diagnosis based on a Mini Mental Status Exam (MMSE) score of <26 and clinical evidence of dementia.(3) People with a lifetime medical history of major systemic illness and neurological disorder records (e.g., stroke, seizure, (4) traumatic brain injury, post brain surgery), brain implants (neurostimulators), cardiac pacemakers, and (5) pregnant women were also excluded. (6) regarding to potential safety issues during the monotherapy period of brain stimulation, patients with a current strong suicidal risk (i.e., a score of 4 on item 3 of the HDRS-17) (7)receiving bupropion >300 mg/day due to dose-dependent increased risk of seizures, or receiving lorazepam >2 mg/day or any anticonvulsant due to reduced cortical excitability which may interfere with rTMS efficacy were excluded

Target sample size

210


Research contact person

Name of lead principal investigator

1st name Cheng-Ta
Middle name
Last name Li

Organization

Taipei Veterans General Hospital, Taiwan

Division name

Department of Psychiatry

Zip code

112

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 Cheng-Ta
Middle name
Last name Li

Organization

Taipei Veterans General Hospital, Taiwan

Division name

Department of Psychiatry

Zip code

112

Address

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

TEL

+88628757027

Homepage URL


Email

on5083@msn.com


Sponsor or person

Institute

Grant of Taipei Veterans General Hospital, Taiwan

Institute

Department

Personal name



Funding Source

Organization

Taipei Veterans General Hospital, Taiwan

Organization

Division

Category of Funding Organization

Outside Japan

Nationality of Funding Organization

Taiwan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Taipei Veterans General Hospital, Taiwan

Address

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

Tel

+88628757384

Email

wtchang2@vghtpe.gov.tw


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

2021 Year 07 Month 27 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

Enrolling by invitation

Date of protocol fixation

2020 Year 11 Month 01 Day

Date of IRB

2020 Year 11 Month 13 Day

Anticipated trial start date

2021 Year 07 Month 27 Day

Last follow-up date

2022 Year 11 Month 12 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2021 Year 07 Month 25 Day

Last modified on

2021 Year 07 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051350


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name