Psychotic DisordersNCT06581302
Magnetic Seizure Therapy for Psychotic Disorders
A study testing Magnetic seizure therapy by Magnetic stimulator and Antipsychotic medications (such as olanzpine, risperidone, aripiprazole, quetiapine, amisulpride, etc) in people with Psychotic Disorders, run by Shanghai Jiao Tong University School of Medicine at 2 sites in China.
Trial summary
This trial aims to evaluate the efficacy and safety of Magnetic Seizure Therapy (MST) as an augmentation of antipsychotic medications for psychosis. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Psychotic Disorders
- What is being tested?
- Magnetic seizure therapy by Magnetic stimulator and Antipsychotic medications (such as olanzpine, risperidone, aripiprazole, quetiapine, amisulpride, etc)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesChina
- Study dates
- 1 Sep 2024to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- (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.
Who cannot join
- (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;
Show all 10Show fewer
- (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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Not yet recruiting
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
Jijun Wang, MD, PhD
jijunwang27@163.com
- Recruiting
Shanghai Mental Health Center
Shanghai, Shanghai Municipality
Yawen Hong, 86-21-34779305, h1881513@163.com
About this study
Official title: 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.
Read the 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
- Being tested
- Magnetic seizure therapy by Magnetic stimulator, Antipsychotic medications (such as olanzpine, risperidone, aripiprazole, quetiapine, amisulpride, etc)
- Keywords
- Magnetic Seizure Therapy (MST), psychotic disorders, longitudinal study
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic seizure therapy by Magnetic stimulatorDevice
Also called Seizure therapy
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 medications (such as olanzpine, risperidone, aripiprazole, quetiapine, amisulpride, etc)Drug
Also called antipsychotics
It mainly includes second-generation antipsychotic medications, such as olanzpine, risperidone, aripiprazole, quetiapine, amisulpride, etc, but except clozapine.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Antipsychotic medications (such as olanzpine, risperidone, aripiprazole, quetiapine, amisulpride, etc) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Positive and Negative Symptom Scale (PANSS)
measured by Positive and Negative Symptom Scale (PANSS)
Measured: Baseline, 1 weeks, 2 weeks, 6 weeks
Secondary outcomes (9)
Changes in cognition
measured by MCCB cognition tests
Measured: Baseline, 1 weeks, 2 weeks
Changes of ictal EEG feature
measured by electroencephalogram (EEG)
Measured: during each treatment
Changes of cortical inhibition
measured by TMS evoked potentials (TEP)
Measured: baseline, 2 weeks
Changes of brain grey matter
measured by structural MRI images of brain
Measured: baseline, 2 weeks
Changes in 24-item Hamilton Depression Rating Scale (HAM-D)
measured by 24-item Hamilton Depression Rating Scale (HAM-D)
Measured: Baseline, 1 weeks, 2 weeks, 6 weeks
Changes in Hamilton Anxiety Scale (HAMA)
measured by Hamilton Anxiety Scale (HAMA)
Measured: Baseline, 1 weeks, 2 weeks, 6 weeks
Changes in Clinical Global Impression (CGI) scale
measured by Clinical Global Impression (CGI) scale
Measured: Baseline, 2 weeks, 6 weeks
Changes in Global Assessment of Functioning (GAF) scale
measured by Global Assessment of Functioning (GAF) scale
Measured: Baseline, 2 weeks, 6 weeks
Changes in brain gamma band signal
Gamma band signal will be measured by magnetoencephalogram (MEG)
Measured: Baseline, 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study start1 Sep 2024
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Psychotic DisordersStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jijun Wang, Shanghai Jiao Tong University School of Medicine
- Investigators
- Jijun Wang, M.D, Ph.D, Principal investigator, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06581302
- Sponsor's protocol ID
- 2023-TX-002
- Status last verified
- Oct 2025
- First submitted
- 15 Aug 2024
- Last updated
- 25 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34899429Jiang 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.
PubMed 29896130Daskalakis 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.
PubMed 34749782Daskalakis 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.
PubMed 34895296
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accelerated 100Hz Magnetic Seizure Therapy for Psychotic Disorders
- ClinicalTrials.gov ID
- NCT06581302
- Acronym / sponsor ID
- 2023-TX-002
- Conditions
- Psychotic Disorders
- Keywords
- Magnetic Seizure Therapy (MST), psychotic disorders, longitudinal study
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 3 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Magnetic seizure therapy plus antipsychotics | Experimental | Device: Magnetic seizure therapy by Magnetic stimulatorThe 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. |
| antipsychotic drugs | Active comparator | Drug: Antipsychotic medications (such as olanzpine, risperidone, aripiprazole, quetiapine, amisulpride, etc)The patients will receive second-generation antipsychotic drugs without MST or ECT during the first 2 weeks. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- (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.
Key exclusion criteria (10 listed)
- (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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic seizure therapy by Magnetic stimulatorAlso: Seizure therapyThe seizure is induced by Magnetic stimulator of MagPro MST(XP)，MagVenture A/S, Farum, Denmark. It is administered in combinations with antipsychotic medications | Device | Magnetic seizure therapy plus antipsychotics |
| Antipsychotic medications (such as olanzpine, risperidone, aripiprazole, quetiapine, amisulpride, etc)Also: antipsychoticsIt mainly includes second-generation antipsychotic medications, such as olanzpine, risperidone, aripiprazole, quetiapine, amisulpride, etc, but except clozapine. | Drug | antipsychotic drugs |
Primary outcome
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)
9 secondary outcomes
Changes in cognition
Time frame: Baseline, 1 weeks, 2 weeks
Changes of ictal EEG feature
Time frame: during each treatment
Changes of cortical inhibition
Time frame: baseline, 2 weeks
Changes of brain grey matter
Time frame: baseline, 2 weeks
Changes in 24-item Hamilton Depression Rating Scale (HAM-D)
Time frame: Baseline, 1 weeks, 2 weeks, 6 weeks
Changes in Hamilton Anxiety Scale (HAMA)
Time frame: Baseline, 1 weeks, 2 weeks, 6 weeks
Changes in Clinical Global Impression (CGI) scale
Time frame: Baseline, 2 weeks, 6 weeks
Changes in Global Assessment of Functioning (GAF) scale
Time frame: Baseline, 2 weeks, 6 weeks
Changes in brain gamma band signal
Time frame: Baseline, 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Background: PubMed 34899429Jiang 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.
- Background: PubMed 29896130Jiang 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.
- Background: PubMed 34749782Daskalakis 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.
- Background: PubMed 34895296Daskalakis 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jijun Wang, M.D, Ph.D principal investigator
Shanghai Mental Health Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic seizure therapy by Magnetic stimulator and Antipsychotic medications (such as olanzpine, risperidone, aripiprazole, quetiapine, amisulpride, etc) in people with Psychotic Disorders, run by Shanghai Jiao Tong University School of Medicine at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jijun Wang, M.D, Ph.D (86-21-34773065, jijunwang27@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Positive and Negative Symptom Scale (PANSS) (time frame: Baseline, 1 weeks, 2 weeks, 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06581302, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.