UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061675 |
|---|---|
| Receipt number | R000070569 |
| Scientific Title | Optimizing TMS Intervention Strategy in Treatment-Resistant Depression for Treating Mood and Anhedonia-Leveraging a Series of Double-Blind Randomized Controlled Trials Targeting the Orbitofrontal Cortex through Integrated Functional Neuroimaging and TMS-EEG Combination Study |
| Date of disclosure of the study information | 2026/05/26 |
| Last modified on | 2026/05/24 19:02:43 |
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Basic information
Public title
Optimizing TMS Intervention Strategy in Treatment-Resistant Depression for Treating Mood and Anhedonia-Leveraging a Series of Double-Blind Randomized Controlled Trials Targeting the Orbitofrontal Cortex through Integrated Functional Neuroimaging and TMS-EEG Combination Study
Acronym
OPTIMAL OFC Study
Scientific Title
Optimizing TMS Intervention Strategy in Treatment-Resistant Depression for Treating Mood and Anhedonia-Leveraging a Series of Double-Blind Randomized Controlled Trials Targeting the Orbitofrontal Cortex through Integrated Functional Neuroimaging and TMS-EEG Combination Study
Scientific Title:Acronym
OPTIMAL OFC Study
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 inhibitory right lateral OFC, excitatory medial OFC, inhibitory right lateral OFC+exctatiry medial OFC, and sham stimulation in the treatment of refractory major depressive patients.
Basic objectives2
Others
Basic objectives -Others
We further evaluate whether clinical characteristics and multimodal biomarkers, including EEG, TMS-EEG, fMRI, and structural MRI, can predict clinical response to inhibitory, excitatory, and combined OFC stimulation protocols, and investigate the mechanisms underlying antidepressant and anti-anhedonia effects.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in the 17-item Hamilton Depression Rating Scale score from baseline to Week 2 after OFC brain stimulation
Key secondary outcomes
Secondary outcomes include changes from baseline to post-treatment and follow-up assessments in resting-state functional connectivity, structural MRI connectivity, EEG, paired-pulse TMS-EEG indices,fNIRS, cognitive function, and clinical symptom measures. Cognitive function will be assessed using the Go/No-Go task, Trail Making Test Part A and Part B, word list recall, and Wisconsin Card Sorting Test. Clinical outcomes include response and remission rates based on HDRS-17 and MADRS, as well as changes in MADRS, HAM-A, DSSS depression and somatic subscales, CGI, YMRS, RRS, SHAPS, UCLA Loneliness Scale, DERS, TCQ, AES, HAQ, PHQ-15, and BDI-II. Exploratory analyses will evaluate whether baseline clinical characteristics, Maudsley Staging Method, TRDSS, and multimodal biomarkers predict treatment response, and whether changes in depressive symptoms are associated with changes in neuroimaging, EEG, and TMS-EEG biomarkers.
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
4
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Inhibitory OFC group (2 sessions/day, 50 mins inter-session, 5 days/week, total 2 weeks and 20 sessions) by 90BFVT-LQC coil
Interventions/Control_2
Excitatory OFC group (2 sessions/day, 50 mins inter-session, 5 days/week, total 2 weeks and 20 sessions) by 90BFVT-LQC coil
Interventions/Control_3
Combined inhibitory and excitatory OFC group (2 sessions/day, 50 mins inter-session, 5 days/week, total 2 weeks and 20 sessions) by 90BFVT-LQC coil
Interventions/Control_4
Sham stimulation group (2 sessions/day, 50 mins inter-session, 5 days/week, total 2 weeks and 20 sessions) by sham coil
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Participants must be able to read, understand, and sign the informed consent form before assessment, and must be able to comply with the study procedures.
2. Participants must meet the DSM-5 criteria for major depressive disorder, recurrent episode, and the current major depressive episode must have lasted for more than 2 weeks.
3. Participants must have at least a moderate level of depressive symptom severity, defined as a 17-item Hamilton Depression Rating Scale (HDRS-17) score of >=18 and a Clinical Global Impression-Severity (CGI-S) score of >=4.
4. Participants must have no major medical or surgical illnesses.
5. History of antidepressant treatment response: Participants must have a history of inadequate response to at least one antidepressant treatment of adequate dose and duration, defined as less than 50% improvement after treatment with an adequate antidepressant regimen, such as escitalopram 10-20 mg/day or an equivalent antidepressant dose, for at least 8 weeks.
6. If participants are receiving concomitant antidepressant medication at study entry, the dosage must have remained stable for at least 4 weeks prior to enrollment and should remain unchanged during the brain stimulation treatment period. If participants are receiving concomitant psychotherapy, the psychotherapy must have been stable for at least 3 months before trial entry, with no anticipated change in treatment frequency.
Key exclusion criteria
1. Participants with a diagnosis of bipolar I or II disorder, schizophrenia, organic brain syndrome, obsessive-compulsive disorder, or major neurocognitive disorder.
2. Participants with a history of substance use disorder within the past 6 months, or those with alcohol or benzodiazepine withdrawal symptoms.
3. Participants who have previously undergone or are scheduled to undergo brain surgery, or who have metallic implants in the brain, such as neurostimulators, or major intracranial abnormalities that may affect safety or confound interpretation of study results, such as brain tumors or arteriovenous malformations. Participants with a family history of epilepsy will also be excluded.
4. Participants with metallic implants or cardiac pacemakers in the body.
5. Participants with severe suicidal ideation within the past week, defined as a score of 4 on item 3, suicidality, of the Hamilton Depression Rating Scale.
6. Women who are pregnant or may be pregnant.
7. Participants who have previously received electroconvulsive therapy but showed less than 50% improvement in depressive symptoms.
8. Participants who have previously received prefrontal repetitive transcranial magnetic stimulation. 9. Participants with anxiety in confined spaces or claustrophobia who are unable to undergo magnetic resonance imaging (MRI).
Target sample size
80
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
Division name
Department of Psychiatry
Zip code
112
Address
No.201, Sec. 2, Shih-Pai Road, Beitou district, Taipei, Taiwan
TEL
88628757027
Homepage URL
cmcheng5@vghtpe.gov.tw
Sponsor or person
Institute
Taipei Veterans General Hospital
Institute
Department
Personal name
Funding Source
Organization
Taipei Veterans General Hospital and National Science and Technology Council, 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
| 2026 | Year | 05 | Month | 26 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 03 | Month | 18 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 18 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2030 | 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
| 2026 | Year | 05 | Month | 24 | Day |
Last modified on
| 2026 | Year | 05 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070569
