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NCT Number: NCT07473648

Multimodal Clinical Study of Electroconvulsive Therapy and Magnetic Seizure Therapy

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

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Key information

Conditions

Electroconvulsive Therapy Depressive Disorder Depressive Disorder, Major Magnetic Seizure Therapy Major Depressive Disorder Mental Disorders Mood Disorders

Age range

12 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 12-80 years;
  • Diagnosis confirmed by two psychiatrists per DSM-5;
  • Stable medication regimen pre-enrollment;
  • Indicated for neuromodulation OR with visual field defects.

Exclusion criteria

  • Major systemic diseases;
  • Prior neuromodulation within 3 months;
  • Pregnancy or potential pregnancy;
  • Metal implants or claustrophobia.

Treatment and study plan

Electroconvulsive therapy

Device

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

Device

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.

Primary outcomes

  1. Change in Hamilton Depression Rating Scale Total Score.

    Time frame: 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.

  2. Change in heart rate variability (HRV) parameters derived from electrocardiogram (ECG).

    Time frame: 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).

  3. Change in Hamilton Anxiety Rating Scale Total Score.

    Time frame: 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.

  4. Change in the Overall Composite Score of the MATRICS Consensus Cognitive Battery.

    Time frame: 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.

Secondary outcomes

  1. Change in resting-state brain activity in specific brain regions.

    Time frame: Baseline and after the completion of the last session (an average of 2 weeks).

    This will be assessed by measuring changes in functional connectivity (FC) OR the amplitude of low-frequency fluctuations (ALFF) within specific brain regions.

Study contacts

Contact information is provided by the study sponsor or research team.

Yanghua Tian PhD

CONTACT

[email protected]

0551 6599 7278

Sponsors and collaborators

Lead sponsor

The Second Hospital of Anhui Medical University

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Mar 16, 2026
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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