Magnetic Seizure Therapy for Psychotic Disorders

NCT ID: NCT06581302

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2025-12-30

Brief Summary

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

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.

Conditions

Psychotic Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Magnetic seizure therapy by Magnetic stimulator

Intervention Type: 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

antipsychotic drugs

The patients will receive second-generation antipsychotic drugs without MST or ECT during the first 2 weeks.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DEVICE

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.

Intervention Type: DRUG

Other Intervention Names

Seizure therapy; antipsychotics

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Jijun Wang

Professor of Department of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jijun Wang, M.D, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Shanghai Mental Health Center

Locations

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, China

Site Status: NOT_YET_RECRUITING

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jijun Wang, M.D, Ph.D

Role: CONTACT

jijunwang27@163.com

86-21-34773065

Facility Contacts

Jijun Wang, MD, PhD

Role: primary

Role: backup

jijunwang27@163.com

Yawen Hong

Role: primary

h1881513@163.com

86-21-34779305

References

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.

Reference Type: BACKGROUND

PMID: 34899429 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29896130 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34749782 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34895296 (View on PubMed)

Other Identifiers

2023-TX-002

Identifier Type: -

Identifier Source: org_study_id