Psychotic Disorders
Conditions
Keywords
Magnetic Seizure Therapy (MST), psychotic disorders, longitudinal study
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.
Interventions
DEVICEMagnetic 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
DRUGAntipsychotic 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.
Sponsors
Shanghai Jiao Tong University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Positive and Negative Symptom Scale (PANSS) | Baseline, 1 weeks, 2 weeks, 6 weeks | measured by Positive and Negative Symptom Scale (PANSS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes of ictal EEG feature | during each treatment | measured by electroencephalogram (EEG) |
| Changes of cortical inhibition | baseline, 2 weeks | measured by TMS evoked potentials (TEP) |
| Changes of brain grey matter | baseline, 2 weeks | measured by structural MRI images of brain |
| Changes in 24-item Hamilton Depression Rating Scale (HAM-D) | Baseline, 1 weeks, 2 weeks, 6 weeks | measured by 24-item Hamilton Depression Rating Scale (HAM-D) |
| Changes in cognition | Baseline, 1 weeks, 2 weeks | measured by MCCB cognition tests |
| Changes in Clinical Global Impression (CGI) scale | Baseline, 2 weeks, 6 weeks | measured by Clinical Global Impression (CGI) scale |
| Changes in Global Assessment of Functioning (GAF) scale | Baseline, 2 weeks, 6 weeks | measured by Global Assessment of Functioning (GAF) scale |
| Changes in brain gamma band signal | Baseline, 2 weeks | Gamma band signal will be measured by magnetoencephalogram (MEG) |
| Changes in Hamilton Anxiety Scale (HAMA) | Baseline, 1 weeks, 2 weeks, 6 weeks | measured by Hamilton Anxiety Scale (HAMA) |
Countries
China
Contacts
Primary ContactJijun Wang, M.D, Ph.D
Outcome results
None listed