UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055340 |
|---|---|
| Receipt number | R000063245 |
| Scientific Title | Prefrontal inhibition and oscillations in the core mechanisms of repetitive transcranial magnetic stimulation for treating major depression disorder |
| Date of disclosure of the study information | 2024/08/27 |
| Last modified on | 2024/08/27 01:19:10 |
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Basic information
Public title
Prefrontal inhibition and oscillations in the core mechanisms of repetitive transcranial magnetic stimulation for treating major depression disorder
Acronym
PIOC-rTMS-MDD
Scientific Title
Prefrontal inhibition and oscillations in the core mechanisms of repetitive transcranial magnetic stimulation for treating major depression disorder
Scientific Title:Acronym
PIOC-rTMS-MDD
Region
| Asia(except Japan) |
Condition
Condition
The evidence so far suggests that inhibitory function, especially GABAb-receptor-related LICI in the DLPFC, is key to treatment responses in MDD. iTBS could be effective through the modulation of prefrontal inhibitory function. However, the following questions remain to be answered: (1) the potentially different effects of iTBS and rTMS on PFC inhibitory functions, and (2) the identification of reliable biomarkers, including EEG signals, that could reliably predict the antidepressant effects of rTMS/iTBS.
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the effects of different repetitive transcranial magnetic stimulation parameters, such as iTBS or rTMS, on prefrontal inhibitory function in patients with depression and to identify biomarkers that can predict antidepressant effects. This will assist clinicians in selecting stimulation treatment parameters and improving response rates.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary efficacy outcome was improvement in depression, measured by a percentage change in HDRS-17 score (% HDRS-17) before and after 2 weeks of brain stimulation treatment between the three groups.
Key secondary outcomes
1. The response rate (defined as a >= 50% reduction compared with the baseline HDRS-17 score) and the remission rate (defined as an HDRS-17 score <= 7).
2. Safety.
3. Relationships between EEG variables and LICI improvement.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Group A (iTBS group): A three-pulse 50Hz wave is delivered every 200ms at 80% AMT (light fist clench), with stimulation for 2 seconds followed by an 8-second rest, for 60 cycles, totaling 1800 pulses, once daily, for a total of 10 sessions.
Interventions/Control_2
Group B (rTMS group): Using 10Hz at 120% RMT (hand relaxed), with stimulation for 4 seconds followed by a 16-second rest, for 75 cycles, totaling 3000 pulses, once daily, for a total of 10 sessions.
Interventions/Control_3
Sham group: A standard sham coil (Magstim(R)) is used, with half of the patients following the parameters of Group A and the other half following the parameters of Group B.
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
We aim to recruit 60 MDD patients (10 patients randomly assigned to the sham group) and 20 healthy participants aged 21 to 70 years.
MDD patients:
The diagnosis of recurrent MDD is based on the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria. Diagnoses are established after taking a thorough medical history and conducting a semistructured interview using the Mini International Neuropsychiatric Interview (MINI) (American Psychiatric Association, 1994).
MDD patients are recruited only if their 17-item Hamilton Depression Rating Scale (HDRS-17) score is greater than 18, and their Clinical Global Impressions-Severity (CGI-S) score is greater than 4.
Patients qualify to participate in the study if they have failed to respond to at least one adequate antidepressant treatment for their current episode (e.g., failed to achieve a 50% improvement in depression).
All subjects are required to be antidepressant-free for at least 1 week before the study (excluding those taking fluoxetine within one month).
Healthy participants:
Healthy control subjects must be free from any DSM-IV diagnosis after the MINI interview at baseline.
Key exclusion criteria
1. A lifetime psychiatric diagnosis of psychotic disorder, bipolar disorder, organic mental disorder, substance use disorder (based on DSM-IV criteria), or a lifetime medical history of major systemic illness and neurological disorder (e.g., seizure, cerebrovascular disease, stroke, meningitis, traumatic brain injury).
2. A history of brain surgery, brain implants (e.g., neurostimulators, clips), cardiac pacemakers (e.g., TCP), or any metal device or implant in the body (e.g., neurostimulators, electrodes, cochlear implants).
3. Any major brain organic insults (e.g., brain arteriovenous malformation, cerebral aneurysm, primary or secondary tumors in the central nervous system).
4. Having active suicidal intent or high suicidality, indicated by a score of 4 on the third item of the HDRS-17 in the past week.
5. Women who are pregnant or lactating.
6. Claustrophobia: inability to stay in a closed environment (e.g., MRI scan).
7. Subjects who need to take any drugs that may pose a risk of epilepsy.
8. Presence of any other condition that has the potential to prevent study completion or may confound outcome assessments (e.g., refusal to sign the informed consent, failure to meet inclusion criteria after recruitment).
9. Having received fluoxetine treatment within the past month.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Cheng-Ta |
| Middle name | |
| Last name | Li |
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
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
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
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
| 2024 | Year | 08 | 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
| 2022 | Year | 12 | Month | 31 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 31 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 27 | Day |
Last follow-up date
| 2025 | Year | 07 | 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
| 2024 | Year | 08 | Month | 27 | Day |
Last modified on
| 2024 | Year | 08 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063245
