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NCT Number: NCT06581302

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Mental Health Center, Shanghai, Shanghai Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Magnetic seizure therapy by Magnetic stimulator

Device

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

Antipsychotic medications (such as olanzpine, risperidone, aripiprazole, quetiapine, amisulpride, etc)

Drug

It mainly includes second-generation antipsychotic medications, such as olanzpine, risperidone, aripiprazole, quetiapine, amisulpride, etc, but except clozapine.

Other names: antipsychotics

Primary outcomes

  1. 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)

Secondary outcomes

  1. Changes in cognition

    Time frame: Baseline, 1 weeks, 2 weeks

    measured by MCCB cognition tests

  2. Changes of ictal EEG feature

    Time frame: during each treatment

    measured by electroencephalogram (EEG)

  3. Changes of cortical inhibition

    Time frame: baseline, 2 weeks

    measured by TMS evoked potentials (TEP)

  4. Changes of brain grey matter

    Time frame: baseline, 2 weeks

    measured by structural MRI images of brain

  5. 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)

  6. Changes in Hamilton Anxiety Scale (HAMA)

    Time frame: Baseline, 1 weeks, 2 weeks, 6 weeks

    measured by Hamilton Anxiety Scale (HAMA)

  7. Changes in Clinical Global Impression (CGI) scale

    Time frame: Baseline, 2 weeks, 6 weeks

    measured by Clinical Global Impression (CGI) scale

  8. Changes in Global Assessment of Functioning (GAF) scale

    Time frame: Baseline, 2 weeks, 6 weeks

    measured by Global Assessment of Functioning (GAF) scale

  9. Changes in brain gamma band signal

    Time frame: Baseline, 2 weeks

    Gamma band signal will be measured by magnetoencephalogram (MEG)

Study contacts

Contact information is provided by the study sponsor or research team.

Jijun Wang, M.D, Ph.D

CONTACT

[email protected]

86-21-34773065

Sponsors and collaborators

Lead sponsor

Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study title

Accelerated 100Hz Magnetic Seizure Therapy for Psychotic Disorders

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 3, 2024
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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