Multimodal Clinical Study of Electroconvulsive Therapy and Magnetic Seizure Therapy

Condition(s) studied

Investigational drug(s) / intervention(s)

Electroconvulsive 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: 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.

Study summary

To compare the efficacy and tolerability of Electroconvulsive Therapy (ECT) and Magnetic Seizure Therapy (MST) in patients with major depressive disorder (MDD).

Eligibility

Primary outcome measure(s)

• Change in Hamilton Depression Rating Scale Total Score. — Baseline, immediately after each treatment session during the intervention period, and 6 months after the end of intervention.
  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.
• Change in heart rate variability (HRV) parameters derived from electrocardiogram (ECG). — Baseline, immediately after each treatment session during the intervention period, and 6 months after the end of intervention.
  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).
• Change in Hamilton Anxiety Rating Scale Total Score. — Baseline, immediately after each treatment session during the intervention period, and 6 months after the end of intervention.
  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.
• Change in the Overall Composite Score of the MATRICS Consensus Cognitive Battery. — Baseline and after the completion of the last session (an average of 2 weeks).
  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.

Trial sites (1)

More The Second Hospital of Anhui Medical University trials in China

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