Magnetic Seizure Therapy plus antipsychotics for psychotic disorders

Accelerated 100Hz Magnetic Seizure Therapy for Psychotic Disorders

This trial will test whether adding Magnetic Seizure Therapy to antipsychotic medication helps adults with acute psychotic disorders get better faster and with fewer cognitive side effects than medication alone.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Shanghai Jiao Tong University School of Medicine (other)
• Drugs / interventions: prednisone
• Locations: 2 sites (Shanghai, Shanghai Municipality and 1 other locations)
• Trial ID: NCT06581302 on ClinicalTrials.gov

What this trial studies

Adults aged 18–55 with schizophrenia or other primary psychotic disorders and a PANSS score ≥60 are randomly assigned to receive 10 sessions of Magnetic Seizure Therapy (MST) over 2 weeks in addition to their antipsychotic medication, or to receive antipsychotic medication alone. MST is a modified form of convulsive therapy designed to induce brief seizures using magnetic stimulation and may cause less cognitive disturbance than electroconvulsive therapy. After the 2-week intervention phase, all participants return to routine clinical management while blinded clinical assessments continue for 4 weeks. Safety, symptom change, and speed of response are compared between groups.

Who should consider this trial

Good fit: Adults 18–55 years old with DSM-5 schizophrenia or other primary psychotic disorders, a PANSS score of 60 or higher, and ability to give informed consent are the intended participants.

Not a fit: People with serious medical illnesses, pregnancy, recent substance dependence, prior poor response to ECT/MST, significant neurological disorders, or other exclusions listed by investigators are unlikely to benefit from or be eligible for this intervention.

Why it matters

Potential benefit: If successful, adding MST could provide faster symptom relief for psychosis with fewer cognitive side effects compared with traditional convulsive therapies.

How similar studies have performed: A few small studies have reported antipsychotic effects of MST and less cognitive impact than ECT, but the evidence is limited and not yet definitive.

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.

Where this trial is running

Shanghai, Shanghai Municipality and 1 other locations

• Shanghai Mental Health Center — Shanghai, Shanghai Municipality, China (NOT_YET_RECRUITING)
• Shanghai Mental Health Center — Shanghai, Shanghai Municipality, China (RECRUITING)

Study contacts

• Principal investigator: Jijun Wang, M.D, Ph.D — Shanghai Mental Health Center
• Study coordinator: Jijun Wang, M.D, Ph.D

Conditions: Psychotic Disorders, Magnetic Seizure Therapy, psychotic disorders, longitudinal study