Tokyo, May 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061568) titled 'Immediate effects of electroacupuncture for depressed patients with pain: An fNIRS study' on May 15.

Study Type: Interventional

Study Design: Basic Design - Cross-over Randomization - Randomized Blinding - Open -no one is blinded Control - Placebo

Primary Sponsor: Institute - Saitama Medical University

Condition: Condition - Major depressive disorder Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The purpose of this study is to evaluate the immediate effects of acupuncture on brain activity in depressed patients with pain, by measuring changes in oxygenated hemoglobin (Oxy-Hb) concentration using functional near-infrared spectroscopy (fNIRS). Specifically, the study aims to: (1) evaluate changes in prefrontal cortex activity during acupuncture stimulation; (2) examine changes in brain activity during the Verbal Fluency Task (VFT), as well as subjective pain and mood, before and after acupuncture; and (3) clarify the correlations between prefrontal cortex activity changes and various clinical indicators. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Electroacupuncture Interventions/Control_2 - Minimal acupuncture

Eligibility: Age-lower limit - 18 years-old

Gender - Male and Female Key inclusion criteria - 1) Men and women aged 18 to 64 years. 2) Diagnosis of Major Depressive Disorder (MDD) based on the Diagnostic and Statistical Manual of Mental Disorders, 5th edition, Text Revision (DSM-5-TR) and structured interview using the Mini-International Neuropsychiatric Interview (M.I.N.I.). 3) Hamilton Depression Rating Scale (HAM-D) score of 8 or higher. 4) Pain Visual Analogue Scale (VAS) score of 30 mm or higher. Key exclusion criteria - 1) Comorbidity of other psychiatric disorders, such as schizophrenia or bipolar disorder. 2) History of cerebrovascular disease, malignant tumor, head injury, or neurodegenerative diseases such as Parkinson's disease. 3) Pregnant women, lactating women, or women of childbearing potential who may be pregnant. 4) Severe suicidal ideation. 5) Substance dependence or drug abuse. 6) Contraindications to electroacupuncture. 7) Previous experience of acupuncture treatment within the past month. 8) Individuals judged to be inappropriate for inclusion in the study by the principal investigator or sub-investigator. Target Size - 26

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 05 Month 25 Day Anticipated trial start date - 2026 Year 09 Month 01 Day Last follow-up date - 2029 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070446

Disclaimer: Curated by HT Syndication.