Magnetic Seizure Therapy for Psychotic Disorders

November 24, 2025 updated by: Jijun Wang, Shanghai Jiao Tong University School of Medicine

Accelerated 100Hz Magnetic Seizure Therapy for Psychotic Disorders

This trial aims to evaluate the efficacy and safety of Magnetic Seizure Therapy (MST) as an augmentation of antipsychotic medications for psychosis.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Psychosis is recognized as one of the largest contributors to nonfatal health loss, and substantial portion of patients exhibit resistance to antipsychotics, emphasizing the need for exploring non-pharmacological treatments. In clinical practice, Electroconvulsive therapy (ECT) has been shown to be generally effective in psychosis, but its clinical use sometimes is limited by its cognitive side effects. Magnetic Seizure Therapy (MST) is a novel modification of electroconvulsive therapy (ECT). MST offers the advantages of milder side effects on cognition, a quicker return of orientation, and a shorter duration of post-ictal confusion. A few studies have studied the antipsychotic effect of MST. Therefore, the present study will plan to perform a clinical trial to compare the efficacy of MST treatment plus antipsychotics to antipsychotic medications alone among psychotic disorders in acute phase. In addition, whether MST treatment plus antipsychotics will bring a quicker efficacy response than antipsychotic medications alone is also of important clinical significance. The present trial will plan to administer 10 sessions of MST in 2 weeks, in which the patients will be randomly allocated to either receiving MST+medications or receiving medications alone. After the 2 week's research intervention, all patients will be switched to clinical routine management, but kept under masked clinical assessment for 4 weeks.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200030
        • Not yet recruiting
        • Shanghai Mental Health Center
        • Contact:
          • Jijun Wang, MD, PhD
        • Contact:
      • Shanghai, Shanghai Municipality, China
        • Recruiting
        • Shanghai Mental Health Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • (1) meets the diagnostic criteria for schizophrenia or other primary psychotic disorders according to DSM-5;
  • (2) age range between 18 and 55 years;
  • (3) Positive And Negative Syndrome Scale (PANSS) score≥60;
  • (4) to provide informed consent.

Exclusion Criteria:

  • (1) have a concomitant severe medical illness;
  • (2) are pregnant or intend to get pregnant during the study;
  • (3) have a history of DSM-5 diagnosis of substance dependence or abuse within the past three months;
  • (4) history of traumatic brain injury (with a screening scale score of 7 or above);
  • (5) history of poor response to electroconvulsive therapy or MST;
  • (6) have probable dementia based on study investigator assessment; have any significant neurological disorder or condition likely to be associated with increased intracranial pressure or a space occupying brain lesion, e.g., cerebral aneurysm;
  • (7) presenting with a medical condition, medication, or laboratory anomaly deemed by the investigator to potentially induce psychotic symptoms, or significant cognitive impairment. (e.g., hypothyroidism with low TSH, rheumatoid arthritis requiring high dose prednisone, or Cushing's disease);
  • (8) have an intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed;
  • (9) a score of 18 or more on the 24-item Hamilton Depression Rating Scale (HAM-D);
  • (10) needing ECT treatment immediately due to such dangerous symptoms as suicide, stupor or psychomotor agitation, etc.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Magnetic seizure therapy plus antipsychotics

The patients will receive antipsychotic drugs plus MST during the first 2 weeks.

A TwinCoil of MagPro XP will be positioned centrally over the frontal cortex in the midline position. The output power of MagPro XP is set to 100%, and stimulation frequency is 100 Hz. For MST titration, the first step is given at a 5-second train duration; if there is no seizure, the duration is increased to 10 seconds with a maximum limit of 10 seconds. The subsequent MST treatment will be maintained at 10 seconds. This procedure will be carried out under anesthesia.

A total of up to 10 treatments will be administered to participants, usually five times a week, for 2 weeks.
Device: Magnetic seizure therapy by Magnetic stimulator
The seizure is induced by Magnetic stimulator of MagPro MST(XP)，MagVenture A/S, Farum, Denmark. It is administered in combinations with antipsychotic medications
Other Names:
  • Seizure therapy
Active Comparator: antipsychotic drugs
The patients will receive second-generation antipsychotic drugs without MST or ECT during the first 2 weeks.
Drug: Antipsychotic medications (such as olanzpine, risperidone, aripiprazole, quetiapine, amisulpride, etc)
It mainly includes second-generation antipsychotic medications, such as olanzpine, risperidone, aripiprazole, quetiapine, amisulpride, etc, but except clozapine.
Other Names:
  • antipsychotics

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Positive and Negative Symptom Scale (PANSS)
Time Frame: Baseline, 1 weeks, 2 weeks, 6 weeks
measured by Positive and Negative Symptom Scale (PANSS)
Baseline, 1 weeks, 2 weeks, 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in cognition
Time Frame: Baseline, 1 weeks, 2 weeks
measured by MCCB cognition tests
Baseline, 1 weeks, 2 weeks
Changes of ictal EEG feature
Time Frame: during each treatment
measured by electroencephalogram (EEG)
during each treatment
Changes of cortical inhibition
Time Frame: baseline, 2 weeks
measured by TMS evoked potentials (TEP)
baseline, 2 weeks
Changes of brain grey matter
Time Frame: baseline, 2 weeks
measured by structural MRI images of brain
baseline, 2 weeks
Changes in 24-item Hamilton Depression Rating Scale (HAM-D)
Time Frame: Baseline, 1 weeks, 2 weeks, 6 weeks
measured by 24-item Hamilton Depression Rating Scale (HAM-D)
Baseline, 1 weeks, 2 weeks, 6 weeks
Changes in Hamilton Anxiety Scale (HAMA)
Time Frame: Baseline, 1 weeks, 2 weeks, 6 weeks
measured by Hamilton Anxiety Scale (HAMA)
Baseline, 1 weeks, 2 weeks, 6 weeks
Changes in Clinical Global Impression (CGI) scale
Time Frame: Baseline, 2 weeks, 6 weeks
measured by Clinical Global Impression (CGI) scale
Baseline, 2 weeks, 6 weeks
Changes in Global Assessment of Functioning (GAF) scale
Time Frame: Baseline, 2 weeks, 6 weeks
measured by Global Assessment of Functioning (GAF) scale
Baseline, 2 weeks, 6 weeks
Changes in brain gamma band signal
Time Frame: Baseline, 2 weeks
Gamma band signal will be measured by magnetoencephalogram (MEG)
Baseline, 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Jiao Tong University School of Medicine

Investigators

  • Principal Investigator: Jijun Wang, M.D, Ph.D, Shanghai Mental Health Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2024

Primary Completion (Estimated)

December 30, 2025

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

August 15, 2024

First Submitted That Met QC Criteria

August 30, 2024

First Posted (Actual)

September 3, 2024

Study Record Updates

Last Update Posted (Actual)

November 25, 2025

Last Update Submitted That Met QC Criteria

November 24, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-TX-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Psychotic Disorders

Clinical Trials on Magnetic seizure therapy by Magnetic stimulator

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Colombia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe