UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047897 |
|---|---|
| Receipt number | 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 15:29:50 |
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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
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
vdodaco@gmail.com
Sponsor or person
Institute
Taipei Veterans General Hospital, Taipei, Taiwan
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054609
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