Magnetic Seizure Therapy for Schizophrenia

NCT02746965 | Terminated DMC

• 1 other identifier: SHDC12014111
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief Summary

This trial attempts to evaluate the treatment efficacy of magnetic seizure therapy (MST) and its safety among schizophrenia patients. Half of the participants will be randomized to MST group, while the other half will be randomized to receive electroconvulsive therapy (ECT).

Conditions

Schizophrenia

Keywords

magnetic seizure therapy; randomized controlled trials; schizophrenia; cognition

Outcome Measures

Primary Outcomes (1)

• changes of The Positive and Negative Syndrome Scale (PANSS)

  At baseline, 4-week, 8-week

Secondary Outcomes (7)

• changes in motor threshold (MT)

  At baseline and the day after the first treatment

• changes in brain gamma-aminobutyric acid （GABA）levels

  At baseline, the day after the first treatment, and at 4-week follow-up

• changes in resting state network

  At baseline, the day after the first treatment, and at 4-week follow-up

• changes in auditory evoked potential (AEP)

  At baseline and the day after the first treatment

• changes in Novel P300

  At baseline and the day after the first treatment

Study Arms (2)

magnetic seizure therapy

EXPERIMENTAL

10 treatment sessions of MST, three times per week in the first two weeks, two times per in the following two weeks.

Device: Magpro X100 + Option; Other: treatment as usual (TAU)

electroconvulsive therapy

ACTIVE COMPARATOR

10 treatment sessions of modified-ECT, three times per week in the first two weeks, two times per in the following two weeks.

Device: ThymatronSystem Ⅳ Electroconvulsive System; Other: treatment as usual (TAU)

Interventions

Magpro X100 + Option DEVICE

In addition to treatment as usual (TAU), participants were supposed to receive ten sessions of MST in four weeks, with three sessions per week in the first two weeks and two sessions per week in the following two weeks.

Also known as: magnetic seizure therapy

magnetic seizure therapy

ThymatronSystem Ⅳ Electroconvulsive System DEVICE

In addition to treatment as usual (TAU), participants were supposed to receive ten sessions of modified ECT in four weeks, with three sessions per week in the first two weeks and two sessions per week in the following two weeks.

Also known as: electroconvulsive therapy

electroconvulsive therapy

treatment as usual (TAU) OTHER

Participants will engage in their inpatient treatment program as-usual.

electroconvulsive therapy; magnetic seizure therapy

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• DSM-5 diagnosis of schizophrenia;
• convulsive therapy clinically indicated, such as severe psychomotor excitement or retardation, attempts of suicide, being highly aggressive, pharmacotherapy intolerance, and ineffectiveness of antipsychotics;
• the positive and negative syndrome scale (PANSS)\[20\] score ≥ 60;
• informed consent in written form.

You may not qualify if:

• diagnosis of other mental disorders;
• severe physical diseases, such as stroke, heart failure, liver failure, neoplasm, and immune deficiency;
• present with a laboratory abnormality that could impact on efficacy of treatments or safety of participants;
• failure to respond to an adequate trial of ECT lifetime;
• are pregnant or intend to get pregnant during the study;
• other conditions that investigators consider to be inappropriate to participate in this trial.

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

Location

Related Publications (3)

• Li J, Wang J, Yang Y, Gao J, Zhang X. The Effect of Electroconvulsive and Magnetic Seizure Therapy (MST) on Cortical Thickness in Schizophrenia. CNS Neurosci Ther. 2025 Mar;31(3):e70309. doi: 10.1111/cns.70309.

  PMID: 40032619 DERIVED

• Jiang J, Li J, Xu Y, Zhang B, Sheng J, Liu D, Wang W, Yang F, Guo X, Li Q, Zhang T, Tang Y, Jia Y, Wang J, Li C. Does Electroencephalography Seizure Duration Account for an Adequate Treatment of Magnetic Seizure Therapy for Schizophrenia? J ECT. 2025 Mar 1;41(1):55-61. doi: 10.1097/YCT.0000000000001047. Epub 2024 Aug 21.

  PMID: 39178051 DERIVED

• Jiang J, Li J, Xu Y, Zhang B, Sheng J, Liu D, Wang W, Yang F, Guo X, Li Q, Zhang T, Tang Y, Jia Y, Daskalakis ZJ, Wang J, Li C. Magnetic Seizure Therapy Compared to Electroconvulsive Therapy for Schizophrenia: A Randomized Controlled Trial. Front Psychiatry. 2021 Nov 25;12:770647. doi: 10.3389/fpsyt.2021.770647. eCollection 2021.

  PMID: 34899429 DERIVED

MeSH Terms

Conditions

Schizophrenia

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Chunbo Li, PHD

  Shanghai Mental Health Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2016
• First Posted: April 21, 2016
• Study Start: March 1, 2017
• Primary Completion: July 30, 2018
• Study Completion: July 30, 2018
• Last Updated: May 6, 2022

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)