Tokyo, Oct. 4 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063159) titled 'Evaluation of Electroconvulsive Therapy Using Auditory Evoked Potentials' on Oct. 3.
Study Type:
Observational
Primary Sponsor:
Institute - Aichi Medical University
Condition:
Condition - Depression
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The aim of this study is to investigate changes in the loudness dependence of auditory evoked potentials (LDAEP) and P300-like responses before and after modified electroconvulsive therapy (mECT) in patients with depression. We will also exploratively examine the associations of these electrophysiological measures with depressive symptoms, cognitive function, patient characteristics, and the course of ECT treatment, in order to characterize changes in auditory information processing associated with mECT and the pathophysiological features of depression requiring ECT.
Basic objectives2 - Others
Eligibility:
Age-lower limit - 18
years-old
=
Gender - Male and Female
Key inclusion criteria - Patients who meet the DSM-5-TR diagnostic criteria for major depressive disorder and are scheduled to undergo modified electroconvulsive therapy (mECT).
Key exclusion criteria - Patients with neurological or psychiatric disorders other than depression.
Patients in a stuporous state.
Pregnant patients.
Patients who are unable to clearly perceive the auditory stimulus at the minimum stimulus intensity (55 dB SPL).
Target Size - 50
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2026 Year 10 Month 03 Day
Date of IRB - 2026 Year 06 Month 10 Day
Anticipated trial start date - 2026 Year 10 Month 03 Day
Last follow-up date - 2028 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072288
Disclaimer: Curated by HT Syndication.
