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Name
UMIN ID

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000047897
Receipt No. R000054609
Scientific Title New form of brain stimulation targeting dorsomedial prefrontal cortex in treating refractory depression and the predictive biomarkers of antidepressant efficacy
Date of disclosure of the study information 2022/05/31
Last modified on 2022/06/05

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Basic information
Public title New form of brain stimulation targeting dorsomedial prefrontal cortex in treating refractory depression and the predictive biomarkers of antidepressant efficacy
Acronym Direct comparisons of antidepressant and anti-anxiosomatic effects between 20Hz rTMS, piTBS and sham intervention
Scientific Title New form of brain stimulation targeting dorsomedial prefrontal cortex in treating refractory depression and the predictive biomarkers of antidepressant efficacy
Scientific Title:Acronym Direct comparisons of antidepressant and anti-anxiosomatic effects between 20Hz rTMS, piTBS and sham intervention
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 clinical efficacy of DMPFC-20HZ rTMS, piTBS, and sham stimulation in the treatment of refractory major depressive patients.
Basic objectives2 Others
Basic objectives -Others We further evaluate whether clinical characteristics and biomarkers might predict the clinical efficacy of DMPFC-pTBS or 20Hz-TMS and to investigate the mechanism of antidepressant and anxiosomatic efficacy.
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes the changing of17-items Hamilton Depression Rating Scale (HDRS-17,week-2 vs. baseline) in response to the 2-week DMPFC brain stimulation.
Key secondary outcomes baseline and the changing of resting state functional and structural connectivity, EEG, paired-pulse TMS-EEG; Cognitive function; Response rate and remission rate, evaluated by HDRS-17; the changing of anxiosomatic cluster symptoms derived from HDRS-17, dysphoric cluster symptoms derived from HDRS-17, Montgomery-Asberg Depression Rating Scale (MADRS), Hamilton Anxiety Rating Scale(HAM-A), depression subscale and somatic subscale of Depression and Somatic Symptoms Scale (DSSS), Clinical Global Index (CGI),Young Mania Rating Scale (YMRS),Rumination response scale (RRS), Snaith-Hamilton Pleasure Scale (SHAPS), UCLA loneliness scale, Difficulties in Emotion Regulation Scale (DERS), Taiwan Cognition. Questionnaire (TCQ); the predictive values of Maudsley Staging method for refractoriness and TRD severity scale (TRDSS).

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 Bilateral DMPFC prolonged intermittent theta-burst stimulation (piTBS) group (2 sessions/hemisphere/day, 5 days/week,total 2 weeks); 80% active motor threshold, 1800 pulses/session
Interventions/Control_2 Bilateral DMPFC 20Hz-rTMS group (2 sessions/hemisphere/day, 5 days/week,total 2 weeks); 100% resting motor threshold, 2000 pulses/session
Interventions/Control_3 Sham group (2 sessions/hemisphere/day, 5 days/week, total 2 weeks); randomly divided to half with piTBS 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 (1) adult patients with the relapse of major depressive episode
(2) Severity: 17 items HDRS >=18; CGI>=4
(3) Poor response to at least one antidepressant
(4) keep the antidepressant and its dosage at least 4 weeks before entering the trial; no adjustment of antidepressant during the trial.
Key exclusion criteria Patients with schizophrenia, bipolar I&II disorder, organic mental disorder and major physical illness; with brain implants or cardiac pacemakers; pregnancy; or who having strong suicidal risk; poor response to previous ECT or 10Hz left DLPFC rTMS/piTBS; claustrophobia for MRI screening; patients who cannot cooperate the trial protocol
Target sample size 75

Research contact person
Name of lead principal investigator
1st name Chih-Ming
Middle name
Last name Cheng
Organization Taipei Veterans General Hospital, Taipei, Taiwan
Division name Department of Psychiatry
Zip code 112
Address No.201, Sec. 2, Shih-Pai Road, Beitou district, Taipei, Taiwan
TEL 88628757027
Email vdodaco@gmail.com

Public contact
Name of contact person
1st name Chih-Ming
Middle name
Last name Cheng
Organization Taipei Veterans General Hospital, Taipei, 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 vdodaco@gmail.com

Sponsor
Institute Taipei Veterans General Hospital, Taipei, Taiwan
Institute
Department

Funding Source
Organization Taipei Veterans General Hospital, Taipei, 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 Institutional Review Board, Taipei Veterans General Hospital, Taipei, Taiwan
Address NO.201, SEC. 2, SHIPAI RD, Taipei City, Taiwan
Tel 886-2-2875-7384
Email irbopinion@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
2022 Year 05 Month 31 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
2022 Year 01 Month 25 Day
Date of IRB
2022 Year 02 Month 16 Day
Anticipated trial start date
2022 Year 05 Month 31 Day
Last follow-up date
2024 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
2022 Year 05 Month 31 Day
Last modified on
2022 Year 06 Month 05 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054609

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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