Magnetic Seizure Therapy for Psychotic Disorders
Recruiting · NCT06581302 · Interventional (participants receive a specific treatment) · Lead sponsor: Shanghai Jiao Tong University School of Medicine
View the official record on ClinicalTrials.gov →Interventions studied
Antipsychotic medications (such as olanzpine, risperidone, aripiprazole, quetiapine, amisulpride, etc)Magnetic seizure therapy by Magnetic stimulator
What this trial is about
This trial aims to evaluate the efficacy and safety of Magnetic Seizure Therapy (MST) as an augmentation of antipsychotic medications for psychosis.
Who can take part
Age range
18 Years to 55 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 it is running
2 locations listed.
- Shanghai Mental Health Center - Shanghai, Shanghai Municipality, China
- Shanghai Mental Health Center - Shanghai, Shanghai Municipality, China