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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electroconvulsive Therapy (ECT) Group | Experimental | 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. |
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| Magnetic Seizure Therapy (MST) Group | Experimental | 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. |
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| Healthy Control Group | Other | Healthy volunteers with no history of major neuropsychiatric disorders. They do not receive any neuromodulation intervention (ECT or MST) or study-related pharmacotherapy. They undergo the same cognitive and behavioral assessments at matched time points to provide normative baseline data for comparison. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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). | 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. | 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. | Baseline and after the completion of the last session (an average of 2 weeks). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and after the completion of the last session (an average of 2 weeks). |
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Patients 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.
Patients Exclusion Criteria:
Major systemic diseases; Prior neuromodulation within 3 months; Pregnancy or potential pregnancy; Metal implants or claustrophobia.
Healthy Control Inclusion Criteria:
Aged 12-80 years; No history of neuropsychiatric disorders; No significant systemic diseases; Normal or corrected vision.
Healthy Control Exclusion Criteria:
Metal implants or claustrophobia; Ocular diseases or surgery history.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yanghua Tian PhD | Contact | 0551 6599 7278 | zylykd@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui Medical University | Recruiting | Hefei | Anhui | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28292650 | Result | Hirano J, Takamiya A, Yamagata B, Hotta S, Miyasaka Y, Pu S, Iwanami A, Uchida H, Mimura M. Frontal and temporal cortical functional recovery after electroconvulsive therapy for depression: A longitudinal functional near-infrared spectroscopy study. J Psychiatr Res. 2017 Aug;91:26-35. doi: 10.1016/j.jpsychires.2017.02.018. Epub 2017 Feb 22. | |
| 31237182 |
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The investigators have not yet finalized a plan for IPD sharing. A decision regarding data sharing, including the types of data to be shared, the timing, and the access procedures, will be made prior to the completion of the study and will be documented in the statistical analysis plan (SAP) or a separate data sharing plan. Any updates will be reflected in the registry record.
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| 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. |
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| Cognitive and Behavioral Assessment | Other | Participants will undergo a series of standardized cognitive tests (e.g., MCCB) and behavioral assessments (e.g., clinical rating scales) at specified time points. This does not constitute a therapeutic intervention but is for the purpose of data collection to establish normative baseline performance. |
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| Downey D, Brigadoi S, Trevithick L, Elliott R, Elwell C, McAllister-Williams RH, Anderson IM. Frontal haemodynamic responses in depression and the effect of electroconvulsive therapy. J Psychopharmacol. 2019 Aug;33(8):1003-1014. doi: 10.1177/0269881119858313. Epub 2019 Jun 25. |
| 39853313 | Result | Chhoa KH, Chiang SK, Ong KY, Yong CK, Ng BZ, Othman SZ, McIntyre RS, Choi J, Cha J, Ho RC, Chee KY. Changes in Cerebral Hemodynamic Among Patients With Schizophrenia or Bipolar Disorder Receiving Electroconvulsive Therapy: A Task-Related Functional Near-Infrared Spectroscopy Study. J ECT. 2026 Mar 1;42(1):11-18. doi: 10.1097/YCT.0000000000001110. Epub 2025 Jan 24. |
| 41070420 | Result | Wang W, Lu Y, Mi GL, Li XJ, Zhang DN, Qi SF. Cognitive preservation advantage and efficacy balance of magnetic seizure therapy in adolescent Major Depressive Disorder: a randomized controlled trial revealing efficacy cognition decoupling phenomenon. Riv Psichiatr. 2025 Sep-Oct;60(5):196-201. doi: 10.1708/4583.45901. |
| 12865903 | Result | Lisanby SH, Luber B, Schlaepfer TE, Sackeim HA. Safety and feasibility of magnetic seizure therapy (MST) in major depression: randomized within-subject comparison with electroconvulsive therapy. Neuropsychopharmacology. 2003 Oct;28(10):1852-65. doi: 10.1038/sj.npp.1300229. |
| 34131914 | Result | Jiang J, Zhang C, Li C, Chen Z, Cao X, Wang H, Li W, Wang J. Magnetic seizure therapy for treatment-resistant depression. Cochrane Database Syst Rev. 2021 Jun 16;6(6):CD013528. doi: 10.1002/14651858.CD013528.pub2. |
| 38055283 | Result | Deng ZD, Luber B, McClintock SM, Weiner RD, Husain MM, Lisanby SH. Clinical Outcomes of Magnetic Seizure Therapy vs Electroconvulsive Therapy for Major Depressive Episode: A Randomized Clinical Trial. JAMA Psychiatry. 2024 Mar 1;81(3):240-249. doi: 10.1001/jamapsychiatry.2023.4599. |
| 38642570 | Result | GBD 2021 Diseases and Injuries Collaborators. Global incidence, prevalence, years lived with disability (YLDs), disability-adjusted life-years (DALYs), and healthy life expectancy (HALE) for 371 diseases and injuries in 204 countries and territories and 811 subnational locations, 1990-2021: a systematic analysis for the Global Burden of Disease Study 2021. Lancet. 2024 May 18;403(10440):2133-2161. doi: 10.1016/S0140-6736(24)00757-8. Epub 2024 Apr 17. |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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