Clinical Trial: 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 (Japan)

Tokyo, May 26 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061675) titled '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' on May 26.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Double blind -all involved are blinded Control - Placebo

Primary Sponsor: Institute - Taipei Veterans General Hospital

Condition: Condition - A treatment option for Medication-resistant depression Classification by malignancy - Others Genomic information - NO

Objective: 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

Intervention: 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

Eligibility: Age-lower limit - 18 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 Size - 80

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070569

Disclaimer: Curated by HT Syndication.