Magnetic Seizure Therapy for Psychotic Disorders

NCT06581302 | Recruiting

• 1 other identifier: 2023-TX-002
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Psychotic Disorders

Keywords

Magnetic Seizure Therapy (MST); psychotic disorders; longitudinal study

Outcome Measures

Primary Outcomes (1)

• Changes in Positive and Negative Symptom Scale (PANSS)

  measured by Positive and Negative Symptom Scale (PANSS)

  Baseline, 1 weeks, 2 weeks, 6 weeks

Secondary Outcomes (9)

• Changes in cognition

  Baseline, 1 weeks, 2 weeks

• Changes of ictal EEG feature

  during each treatment

• Changes of cortical inhibition

  baseline, 2 weeks

• Changes of brain grey matter

  baseline, 2 weeks

• Changes in 24-item Hamilton Depression Rating Scale (HAM-D)

  Baseline, 1 weeks, 2 weeks, 6 weeks

Study Arms (2)

Magnetic seizure therapy plus antipsychotics

EXPERIMENTAL

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

antipsychotic drugs

ACTIVE COMPARATOR

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)

Interventions

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

Also known as: Seizure therapy

Magnetic seizure therapy plus antipsychotics

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.

Also known as: antipsychotics

antipsychotic drugs

Eligibility Criteria

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

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (2)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

NOT YET RECRUITING

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, China

RECRUITING

Related Publications (4)

• 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 BACKGROUND

• Jiang J, Li Q, Sheng J, Yang F, Cao X, Zhang T, Jia Y, Wang J, Li C. 25 Hz Magnetic Seizure Therapy Is Feasible but Not Optimal for Chinese Patients With Schizophrenia: A Case Series. Front Psychiatry. 2018 May 29;9:224. doi: 10.3389/fpsyt.2018.00224. eCollection 2018.

  PMID: 29896130 BACKGROUND

• Daskalakis ZJ, Tamminga C, Throop A, Palmer L, Dimitrova J, Farzan F, Thorpe KE, McClintock SM, Blumberger DM. Confirmatory Efficacy and Safety Trial of Magnetic Seizure Therapy for Depression (CREST-MST): study protocol for a randomized non-inferiority trial of magnetic seizure therapy versus electroconvulsive therapy. Trials. 2021 Nov 8;22(1):786. doi: 10.1186/s13063-021-05730-7.

  PMID: 34749782 BACKGROUND

• Daskalakis ZJ, McClintock SM, Hadas I, Kallioniemi E, Zomorrodi R, Throop A, Palmer L, Farzan F, Thorpe KE, Tamminga C, Blumberger DM. Confirmatory Efficacy and Safety Trial of Magnetic Seizure Therapy for Depression (CREST-MST): protocol for identification of novel biomarkers via neurophysiology. Trials. 2021 Dec 11;22(1):906. doi: 10.1186/s13063-021-05873-7.

  PMID: 34895296 BACKGROUND

MeSH Terms

Conditions

Psychotic Disorders

Interventions

Risperidone; Aripiprazole; Quetiapine Fumarate; Amisulpride; Antipsychotic Agents

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Benzamides; Amides; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Tranquilizing Agents; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses; Psychotropic Drugs

Study Officials

• Jijun Wang, M.D, Ph.D

  Shanghai Mental Health Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jijun Wang, M.D, Ph.D

CONTACT

86-21-34773065; jijunwang27@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Department of Psychiatry

Study Record Dates

• First Submitted: August 15, 2024
• First Posted: September 3, 2024
• Study Start: September 1, 2024
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: November 25, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)