UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033334 |
|---|---|
| Receipt number | R000037977 |
| Scientific Title | Different forms of prefrontal transcranial stimulation and brain-derived neurotrophic factor in prediction of antidepressant efficacy of brain stimulation |
| Date of disclosure of the study information | 2018/07/09 |
| Last modified on | 2018/07/09 13:48:49 |
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Basic information
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
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 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
Assessment
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.
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
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
Eligibility
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
Research contact person
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
on5083@msn.com
Public contact
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
on5083@msn.com
Sponsor or person
Institute
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, ROC
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2018 | Year | 07 | Month | 09 | 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
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
Other related information
Management 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
