Tokyo, Aug. 16 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062585) titled 'Feasibility and Clinical Utility of a Combined Repetitive Transcranial Magnetic Stimulation (rTMS) and Occupational Therapy Program for Patients with Depression' on Aug. 15.

Study Type: Interventional

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

Primary Sponsor: Institute - Kasadera Seichiryou Hospital

Condition: Condition - mood disorder (depressive disorder) Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The aim of this study is to provide occupational therapy in combination with transcranial magnetic stimulation (TMS) treatment for patients with depression and to examine its feasibility and clinical utility. Specifically, this study will assess the consent rate, intervention initiation rate, retention rate, assessment completion rate, reasons for discontinuation, adverse events, and patient acceptability. In addition, changes in depressive symptoms, cognitive function, physical activity, daily functioning, and social functioning will be evaluated exploratorily. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Combination of Repetitive Transcranial Magnetic Stimulation and Occupational Therapy: Feedback on Activity Levels and Mood

Eligibility: Age-lower limit - 18 years-old = Gender - Male and Female Key inclusion criteria - Patients diagnosed with depression by a physician and deemed eligible for repetitive transcranial magnetic stimulation (rTMS) treatment. Key exclusion criteria - 1Individuals from whom written informed consent for participation in the study cannot be obtained. 2Individuals with a diagnosis of intellectual disability who are judged by the principal investigator to have difficulty understanding the study procedures or completing the study assessments. 3Individuals with a history of head injury or neurological disease that may affect study safety or outcome assessments. 4Individuals experiencing acute intoxication with, or withdrawal from, alcohol or other substances. 5Individuals who are considered unsuitable for participation in the study by the principal investigator or attending physician. Target Size - 30

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2026 Year 07 Month 31 Day Date of IRB - 2026 Year 06 Month 18 Day Anticipated trial start date - 2026 Year 07 Month 31 Day Last follow-up date - 2030 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071045

Disclaimer: Curated by HT Syndication.