An interventional study of Electroconvulsive Therapy and Magnetic Seizure Therapy in Electroconvulsive Therapy, Major Depressive Disorder and Magnetic Seizure Therapy, sponsored by The Second Hospital of Anhui Medical University. Recruiting at 1 site in China. Open to participants aged 12 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-17.
Sponsored by The Second Hospital of Anhui Medical University · Not applicable, Interventional, and Health services research
To compare the efficacy and tolerability of Electroconvulsive Therapy (ECT) and Magnetic Seizure Therapy (MST) in patients with major depressive disorder (MDD).
Exclusion Criteria:
Participants with Major Depressive Disorder(MDD) receive active Electroconvulsive Therapy (ECT) according to the study protocol, in addition to their ongoing standardized pharmacotherapy. This group assesses the efficacy and cognitive effects of ECT.
Device: Electroconvulsive Therapy
Participants with Major Depressive Disorder (MDD) receive active Magnetic Seizure Therapy (MST) according to the study protocol, in addition to their ongoing standardized pharmacotherapy. This group assesses the efficacy and cognitive effects of MST, allowing for comparison with ECT.
Device: Magnetic Seizure Therapy
Electroconvulsive therapy will be administered two to four times a week according to a standardized protocol. Stimulation parameters (including intensity, target location, session number, and duration) will be individualized for each participant based on prior research to ensure targeted and safe delivery within established safety limits. Treatment will continue until the participant meets the protocol-defined response criteria or completes a maximum of 10 sessions.
Magnetic seizure therapy will be administered two to four times a week according to a standardized protocol. Stimulation parameters (including intensity, target location, session number, and duration) will be individualized for each participant based on prior research to ensure targeted and safe delivery within established safety limits. Treatment will continue until the participant meets the protocol-defined response criteria or completes a maximum of 10 sessions.
Change in Hamilton Depression Rating Scale Total Score.
The Hamilton Depression Rating Scale is a clinician-administered scale used to assess the severity of depressive symptoms. The 17-item version (HAMD-17) is most common. Each item is rated on a 3- or 5-point scale. The total score ranges from 0 to 52, with a higher score indicating more severe depression. The primary endpoint is the change in total score from baseline.
Time frame: Baseline, immediately after each treatment session during the intervention period, and 6 months after the end of intervention.
Change in heart rate variability (HRV) parameters derived from electrocardiogram (ECG).
ECG recordings will be analyzed to assess changes in heart rate variability (HRV) as a potential biomarker of autonomic nervous system function in response to treatment. Key parameters include the root mean square of successive differences (RMSSD) and the standard deviation of NN intervals (SDNN).
Time frame: Baseline, immediately after each treatment session during the intervention period, and 6 months after the end of intervention.
Change in Hamilton Anxiety Rating Scale Total Score.
The HAMA is a 14-item clinician-rated scale assessing anxiety severity. Total score ranges from 0 to 56, with higher scores indicating worse anxiety. The change from baseline to the end of treatment will be the primary measure of clinical efficacy.
Time frame: Baseline, immediately after each treatment session during the intervention period, and 6 months after the end of intervention.
Change in the Overall Composite Score of the MATRICS Consensus Cognitive Battery.
The MCCB is a standardized, performance-based cognitive battery used to assess global cognitive functioning. The primary measure is the change in the Overall Composite T-score (derived from 10 tests across 7 domains), with higher scores indicating better cognitive performance. Assessments are administered by trained personnel.
Time frame: Baseline and after the completion of the last session (an average of 2 weeks).
Change in resting-state brain activity in specific brain regions.
This will be assessed by measuring changes in functional connectivity (FC) OR the amplitude of low-frequency fluctuations (ALFF) within specific brain regions.
Time frame: Baseline and after the completion of the last session (an average of 2 weeks).
Plan to share: No — Individual participant data will not be shared with other researchers due to patient privacy protection and the limitations of the informed consent form.
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The Second Hospital of Anhui Medical University