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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000044951
Receipt No. 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

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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
Institute Grant of 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

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
URL(English) 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


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