UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063159 |
|---|---|
| Receipt number | R000072288 |
| Scientific Title | Evaluation of Electroconvulsive Therapy Using Auditory Evoked Potentials |
| Date of disclosure of the study information | 2026/10/03 |
| Last modified on | 2026/10/03 14:38:41 |
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Basic information
Public title
Evaluation of Electroconvulsive Therapy Using Auditory Evoked Potentials
Acronym
A Study of Brain Responses to Sounds Before and After ECT Treatment
Scientific Title
Evaluation of Electroconvulsive Therapy Using Auditory Evoked Potentials
Scientific Title:Acronym
AEP-ECT Study
Region
| Japan |
Condition
Condition
Depression
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Exploration of changes in auditory evoked potentials following mECT and their associations with clinical measures and the course of ECT treatment
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in the N100/P200 LDAEP slope from before initiation of modified electroconvulsive therapy (mECT) to after completion of the mECT treatment course.
Auditory evoked potentials will be recorded at Fz, Cz, and Pz, with Cz prespecified as the primary electrode for electrophysiological analyses. Data from Fz and Pz will be used for supplementary characterization of the scalp distribution of the auditory evoked responses. N100 and P200 will be algorithmically identified as the maximum negative peak within 80 to 150 ms and the maximum positive peak within 150 to 280 ms after auditory stimulus onset, respectively. The N100/P200 peak to peak amplitude will be calculated for each auditory stimulus intensity. The N100/P200 LDAEP slope will be defined as the slope of the linear regression of N100/P200 peak to peak amplitudes against auditory stimulus intensity and will be compared between the pre and post mECT assessments. Auditory evoked potential assessments will be performed in the evening (approximately 6:00 PM) on (1) the day before initiation of the mECT treatment course and (2) the day after completion of the mECT treatment course.
Key secondary outcomes
Secondary outcomes will include changes from before initiation of mECT to after completion of the mECT treatment course in the following measures:
1. P50/N100 slope: P50 will be algorithmically identified as the maximum positive peak within 30 to 80 ms after auditory stimulus onset. The P50/N100 peak to peak amplitude will be calculated for each auditory stimulus intensity. The P50/N100 slope will be defined as the slope of the linear regression of P50/N100 peak-to-peak amplitudes against auditory stimulus intensity and will be compared between the pre and post mECT assessments.
2. P300-like response: The P300-like response will be assessed as the mean amplitude at Cz within 300 to 380 ms after onset of the 95-dB auditory stimulus and will be compared between the pre and post mECT assessments.
3. Depressive symptoms: Depressive symptoms will be assessed using the Hamilton Depression Rating Scale (HAMD) and the Montgomery Asberg Depression Rating Scale (MADRS), and changes from before initiation of mECT to after completion of the mECT treatment course will be evaluated.
4. Cognitive function: Cognitive function will be assessed using the Digit Symbol Substitution Test (DSST), and changes from before initiation of mECT to after completion of the mECT treatment course will be evaluated.
Exploratory analyses will examine associations of baseline N100/P200 LDAEP slope, P50/N100 slope, and P300-like response, as well as their pre-to-post mECT changes, with depressive symptoms, cognitive function, baseline State-Trait Anxiety Inventory (STAI) scores, patient characteristics, DSM-5-TR specifiers, and the course of ECT treatment. ECT treatment-course measures will include the number of ECT sessions, stimulus charge, seizure duration, anesthetic dose, and other relevant treatment parameters.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 100 | 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 sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kohei |
| Middle name | |
| Last name | Fujita |
Organization
Aichi Medical University
Division name
Neuropsychiatric Department
Zip code
454-0926
Address
1-1 Yazakokarimata, Nagakute, Aichi
TEL
0561623311
fujita.kouhei.077@mail.aichi-med-u.ac.jp
Public contact
Name of contact person
| 1st name | Kohei |
| Middle name | |
| Last name | Fujita |
Organization
Aichi Medical University
Division name
Neuropsychiatric Department
Zip code
454-0926
Address
1-1 Yazakokarimata, Nagakute, Aichi
TEL
0561623311
Homepage URL
fujita.kouhei.077@mail.aichi-med-u.ac.jp
Sponsor or person
Institute
Aichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Support Division, Aichi Medical University
Address
1-1 Yazakokarimata, Nagakute, Aichi 480-1195, Japan
Tel
0561623311
kenshi@aichi-med-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a prospective observational study of patients with depression who receive modified electroconvulsive therapy (mECT) as part of routine clinical care. Auditory evoked potentials will be assessed before initiation and after completion of the mECT treatment course to evaluate changes in LDAEP and P300-like responses. Exploratory analyses will also examine the associations of these electrophysiological measures with depressive symptoms, cognitive function, patient characteristics, and the course of ECT treatment. mECT will be administered as part of routine clinical care, and the treatment method, treatment parameters, and treatment course will not be altered by participation in this study.
Management information
Registered date
| 2026 | Year | 10 | Month | 03 | Day |
Last modified on
| 2026 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072288
