Status:
RECRUITING
Magnetic Seizure Therapy for Psychotic Disorders
Lead Sponsor:
Shanghai Jiao Tong University School of Medicine
Conditions:
Psychotic Disorders
Eligibility:
All Genders
18-55 years
Phase:
NA
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-pha...
Eligibility Criteria
Inclusion
- (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
- (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.
Key Trial Info
Start Date :
September 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06581302
Start Date
September 1 2024
End Date
December 30 2025
Last Update
November 25 2025
Active Locations (2)
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1
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, China, 200030
2
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, China