Electroconvulsive Therapy, Magnetic Seizure Therapy, Major Depressive Disorder
Conditions
Keywords
Electroconvulsive Therapy (ECT), Magnetic Seizure Therapy(MST), Major Depressive Disorder(MDD), Electroencephalography(EEG), Resting-state Functional MRI (fMRI)
Brief summary
To compare the efficacy and tolerability of Electroconvulsive Therapy (ECT) and Magnetic Seizure Therapy (MST) in patients with major depressive disorder (MDD).
Interventions
DEVICEElectroconvulsive 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.
DEVICEMagnetic 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.
Sponsors
The Second Hospital of Anhui Medical University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 80 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in resting-state brain activity in specific brain regions. | 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. |
Countries
China
Contacts
CONTACTYanghua Tian PhD
Outcome results
None listed