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
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
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
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
