Multimodal Clinical Study of Electroconvulsive Therapy and Magnetic Seizure Therapy

NCT07473648 | Recruiting DMC

• 1 other identifier: AHMU-MST/ECT-MDD
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Electroconvulsive Therapy; Major Depressive Disorder; Magnetic Seizure Therapy

Keywords

Electroconvulsive Therapy (ECT); Magnetic Seizure Therapy(MST); Major Depressive Disorder(MDD); Electroencephalography(EEG); Resting-state Functional MRI (fMRI)

Outcome Measures

Primary Outcomes (4)

• 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).

Secondary Outcomes (1)

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

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

Study Arms (3)

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.

Device: Electroconvulsive Therapy; Other: Cognitive and Behavioral Assessment

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.

Device: Magnetic Seizure Therapy; Other: Cognitive and Behavioral Assessment

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.

Other: Cognitive and Behavioral Assessment

Interventions

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.

Electroconvulsive Therapy (ECT) Group

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.

Magnetic Seizure Therapy (MST) Group

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.

Electroconvulsive Therapy (ECT) Group; Healthy Control Group; Magnetic Seizure Therapy (MST) Group

Eligibility Criteria

• Age: 12 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Major systemic diseases; Prior neuromodulation within 3 months; Pregnancy or potential pregnancy; Metal implants or claustrophobia.
• Aged 12-80 years; No history of neuropsychiatric disorders; No significant systemic diseases; Normal or corrected vision.
• Metal implants or claustrophobia; Ocular diseases or surgery history.

Sponsors & Collaborators

• The Second Hospital of Anhui Medical University: lead

Study Sites (1)

Anhui Medical University

Hefei, Anhui, China

RECRUITING

Related Publications (8)

• 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.

  PMID: 28292650 RESULT

• 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.

  PMID: 31237182 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.

  PMID: 39853313 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.

  PMID: 41070420 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.

  PMID: 12865903 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.

  PMID: 34131914 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.

  PMID: 38055283 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.

  PMID: 38642570 RESULT

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Central Study Contacts

Yanghua Tian PhD

CONTACT

0551 6599 7278; zylykd@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President of Anhui Medical University

Study Record Dates

• First Submitted: February 7, 2026
• First Posted: March 16, 2026
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: March 16, 2026

Record last verified: 2026-03

Locations

CN (1)