Clinical Trial: Study of Changes in Brain Structure and Function Before and After Magnetic Seizure Therapy (MST) for Treatment-Resistant Depression (Japan)

Tokyo, Sept. 29 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063075) titled 'Study of Changes in Brain Structure and Function Before and After Magnetic Seizure Therapy (MST) for Treatment-Resistant Depression' on Sept. 28.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Self control

Primary Sponsor: Institute - Kyoto University

Condition: Condition - Depression Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To characterize changes in brain structure, brain function, and microstructure before and after magnetic seizure therapy (MST) in patients with treatment-resistant depression, by examining correlations with clinical measures and comparing these changes with those observed before and after electroconvulsive therapy (ECT). Basic objectives2 - Others

Intervention: Interventions/Control_1 - Non-contrast MRI will be performed for research purposes. Participants will undergo three 3-T MRI assessments: within 1 month before treatment initiation, within 2 weeks after the final treatment session (excluding the following day), and 6 months (plus or minus 1 month) after enrollment in this imaging study. Participants enrolled at Kyoto University will additionally undergo 7-T MRI before and after treatment. Brain structure, microstructure, and resting-state brain function will be assessed. MRI assessments will take approximately 60-90 minutes per time point and approximately 60 minutes at the 6-month follow-up. MST treatment allocation follows the parent clinical trial, while ECT is provided according to clinical decisions; this imaging study does not allocate treatment. Individuals whose existing data from the C0810 study are used will undergo no additional imaging or intervention.

Eligibility: Age-lower limit - 16 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Individuals meeting one of the following criteria: 1. MST group: Patients with treatment-resistant depression participating in the parent MST trial (MSTD-001), aged 18-80 years at consent for that trial. Both active MST and sham MST groups are included. 2. ECT group: Individuals aged 18 years or older at enrollment in this imaging study who receive clinically indicated ECT for a depressive episode. 3. Depression and healthy participant groups using existing C0810 data: Individuals aged 16 years or older when the data to be used were acquired. Only existing data will be used; no additional examinations will be performed. Key exclusion criteria - 1. Individuals with contraindications to MRI. 2. Individuals with conditions that may substantially affect the assessment of central nervous system structure or function, including neurological disorders, brain tumors, cerebrovascular disease, traumatic brain injury, or neurodegenerative diseases. 3. Individuals whose participation is judged by the investigators to potentially adversely affect their symptoms or health. Target Size - 135

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 09 Month 28 Day Anticipated trial start date - 2026 Year 11 Month 01 Day Last follow-up date - 2032 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072204

Disclaimer: Curated by HT Syndication.