Electroconvulsive TherapyNCT07473648
Multimodal Clinical Study of Electroconvulsive Therapy and Magnetic Seizure Therapy
A study testing Electroconvulsive Therapy and Magnetic Seizure Therapy in people with Electroconvulsive Therapy and Major Depressive Disorder, run by The Second Hospital of Anhui Medical University at 1 site in China.
Trial summary
To compare the efficacy and tolerability of Electroconvulsive Therapy (ECT) and Magnetic Seizure Therapy (MST) in patients with major depressive disorder (MDD). Read more about this study
- Who is it for?
- Ages 12 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Electroconvulsive Therapy, Major Depressive Disorder, Magnetic Seizure Therapy
- What is being tested?
- Electroconvulsive Therapy and Magnetic Seizure Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2025to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Major systemic diseases;
- Prior neuromodulation within 3 months;
- Pregnancy or potential pregnancy;
- Metal implants or claustrophobia.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Anhui Medical University
Hefei, Anhui
Yanghua Tian PhD, 0551 6599 7278, ayfytyh@126.com
About this study
To compare the efficacy and tolerability of Electroconvulsive Therapy (ECT) and Magnetic Seizure Therapy (MST) in patients with major depressive disorder (MDD).
- Being tested
- Electroconvulsive Therapy, Magnetic Seizure Therapy
- Keywords
- Electroconvulsive Therapy (ECT), Magnetic Seizure Therapy(MST), Major Depressive Disorder(MDD), Electroencephalography(EEG), Resting-state Functional MRI (fMRI)
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electroconvulsive TherapyDevice
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 TherapyDevice
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Electroconvulsive Therapy |
| 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. Receives: Device: Magnetic Seizure Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Baseline and after the completion of the last session (an average of 2 weeks).
Secondary outcomes (1)
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.
Measured: Baseline and after the completion of the last session (an average of 2 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start1 Sep 2025
- Primary completionDec 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Electroconvulsive TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Anhui Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanghua Tian, The Second Hospital of Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07473648
- Sponsor's protocol ID
- AHMU-MST/ECT-MDD
- Status last verified
- Mar 2026
- First submitted
- 7 Feb 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers due to patient privacy protection and the limitations of the informed consent form.
Publications
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.
PubMed 28292650Downey 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.
PubMed 31237182Chhoa 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.
PubMed 39853313Wang 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.
PubMed 41070420Lisanby 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.
PubMed 12865903Jiang 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.
PubMed 34131914Deng 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.
PubMed 38055283GBD 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.
PubMed 38642570
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Clinical Study of Electroconvulsive Therapy and Magnetic Seizure Therapy
- ClinicalTrials.gov ID
- NCT07473648
- Acronym / sponsor ID
- AHMU-MST/ECT-MDD
- Keywords
- Electroconvulsive Therapy (ECT), Magnetic Seizure Therapy(MST), Major Depressive Disorder(MDD), Electroencephalography(EEG), Resting-state Functional MRI (fMRI)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The Second Hospital of Anhui Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 16 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the efficacy and tolerability of Electroconvulsive Therapy (ECT) and Magnetic Seizure Therapy (MST) in patients with major depressive disorder (MDD).
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electroconvulsive Therapy (ECT) Group | Experimental | Device: Electroconvulsive TherapyParticipants 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. |
| Magnetic Seizure Therapy (MST) Group | Experimental | Device: Magnetic Seizure TherapyParticipants 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. |
Who may qualify
- Ages
- 12 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- Major systemic diseases;
- Prior neuromodulation within 3 months;
- Pregnancy or potential pregnancy;
- Metal implants or claustrophobia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electroconvulsive TherapyElectroconvulsive 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. | Device | Electroconvulsive Therapy (ECT) Group |
| Magnetic Seizure TherapyMagnetic 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. | Device | Magnetic Seizure Therapy (MST) Group |
Primary outcome
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.
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).
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.
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.
1 secondary outcome
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Results publication: PubMed 28292650Hirano 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.
- Results publication: PubMed 31237182Downey 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.
- Results publication: PubMed 39853313Chhoa 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.
- Results publication: PubMed 41070420Wang 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.
- Results publication: PubMed 12865903Lisanby 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.
- Results publication: PubMed 34131914Jiang 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.
- Results publication: PubMed 38055283Deng 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.
- Results publication: PubMed 38642570GBD 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.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electroconvulsive Therapy and Magnetic Seizure Therapy in people with Electroconvulsive Therapy and Major Depressive Disorder, run by The Second Hospital of Anhui Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yanghua Tian PhD (0551 6599 7278, zylykd@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07473648, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.