This trial aims to evaluate the efficacy and safety of Magnetic Seizure Therapy (MST) as an augmentation of antipsychotic medications for psychosis.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
50
The seizure is induced by Magnetic stimulator of MagPro MST(XP),MagVenture A/S, Farum, Denmark. It is administered in combinations with antipsychotic medications
It mainly includes second-generation antipsychotic medications, such as olanzpine, risperidone, aripiprazole, quetiapine, amisulpride, etc, but except clozapine.
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, China
NOT_YET_RECRUITINGShanghai Mental Health Center
Shanghai, Shanghai Municipality, China
RECRUITINGChanges in Positive and Negative Symptom Scale (PANSS)
measured by Positive and Negative Symptom Scale (PANSS)
Time frame: Baseline, 1 weeks, 2 weeks, 6 weeks
Changes in cognition
measured by MCCB cognition tests
Time frame: Baseline, 1 weeks, 2 weeks
Changes of ictal EEG feature
measured by electroencephalogram (EEG)
Time frame: during each treatment
Changes of cortical inhibition
measured by TMS evoked potentials (TEP)
Time frame: baseline, 2 weeks
Changes of brain grey matter
measured by structural MRI images of brain
Time frame: baseline, 2 weeks
Changes in 24-item Hamilton Depression Rating Scale (HAM-D)
measured by 24-item Hamilton Depression Rating Scale (HAM-D)
Time frame: Baseline, 1 weeks, 2 weeks, 6 weeks
Changes in Hamilton Anxiety Scale (HAMA)
measured by Hamilton Anxiety Scale (HAMA)
Time frame: Baseline, 1 weeks, 2 weeks, 6 weeks
Changes in Clinical Global Impression (CGI) scale
measured by Clinical Global Impression (CGI) scale
Time frame: Baseline, 2 weeks, 6 weeks
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Changes in Global Assessment of Functioning (GAF) scale
measured by Global Assessment of Functioning (GAF) scale
Time frame: Baseline, 2 weeks, 6 weeks
Changes in brain gamma band signal
Gamma band signal will be measured by magnetoencephalogram (MEG)
Time frame: Baseline, 2 weeks