Magnetic Seizure Therapy for Psychotic Disorders
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Magnetic seizure therapy by Magnetic stimulator, Antipsychotic medications (such as olanzpine, risperidone, aripiprazole, quetiapine, amisulpride, etc).
- Who it may be relevant to
- Registry conditions: Psychotic Disorders. Basic parameters: 18 years — 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Accelerated 100Hz Magnetic Seizure Therapy for Psychotic Disorders
Overview
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
- Device Magnetic 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 - Drug Antipsychotic 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.
Primary outcome measures
- Changes in Positive and Negative Symptom Scale (PANSS) [Time frame: Baseline, 1 weeks, 2 weeks, 6 weeks]
Secondary outcome measures (9)
- Changes in cognition [Time frame: Baseline, 1 weeks, 2 weeks]
- Changes of ictal EEG feature [Time frame: during each treatment]
- Changes of cortical inhibition [Time frame: baseline, 2 weeks]
- Changes of brain grey matter [Time frame: baseline, 2 weeks]
- Changes in 24-item Hamilton Depression Rating Scale (HAM-D) [Time frame: Baseline, 1 weeks, 2 weeks, 6 weeks]
- Changes in Hamilton Anxiety Scale (HAMA) [Time frame: Baseline, 1 weeks, 2 weeks, 6 weeks]
- Changes in Clinical Global Impression (CGI) scale [Time frame: Baseline, 2 weeks, 6 weeks]
- Changes in Global Assessment of Functioning (GAF) scale [Time frame: Baseline, 2 weeks, 6 weeks]
- Changes in brain gamma band signal [Time frame: Baseline, 2 weeks]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 2 centers
- Shanghai Mental Health Center — Shanghai
- Shanghai Mental Health Center — Shanghai
Publications
- Jiang J, Li J, Xu Y, Zhang B, Sheng J, Liu D, Wang W, Yang F, Guo X, Li Q, Zhang T, Tang Y, Jia Y, Daskalakis ZJ, Wang J, Li C. Magnetic Seizure Therapy Compared to Electroconvulsive Therapy for Schizophrenia: A Randomized Controlled Trial. Front Psychiatry. 2021 Nov 25;12:770647. doi: 10.3389/fpsyt.2021.770647. eCollection 2021. PMID 34899429
- Jiang J, Li Q, Sheng J, Yang F, Cao X, Zhang T, Jia Y, Wang J, Li C. 25 Hz Magnetic Seizure Therapy Is Feasible but Not Optimal for Chinese Patients With Schizophrenia: A Case Series. Front Psychiatry. 2018 May 29;9:224. doi: 10.3389/fpsyt.2018.00224. eCollection 2018. PMID 29896130
- Daskalakis ZJ, Tamminga C, Throop A, Palmer L, Dimitrova J, Farzan F, Thorpe KE, McClintock SM, Blumberger DM. Confirmatory Efficacy and Safety Trial of Magnetic Seizure Therapy for Depression (CREST-MST): study protocol for a randomized non-inferiority trial of magnetic seizure therapy versus electroconvulsive therapy. Trials. 2021 Nov 8;22(1):786. doi: 10.1186/s13063-021-05730-7. PMID 34749782
- Daskalakis ZJ, McClintock SM, Hadas I, Kallioniemi E, Zomorrodi R, Throop A, Palmer L, Farzan F, Thorpe KE, Tamminga C, Blumberger DM. Confirmatory Efficacy and Safety Trial of Magnetic Seizure Therapy for Depression (CREST-MST): protocol for identification of novel biomarkers via neurophysiology. Trials. 2021 Dec 11;22(1):906. doi: 10.1186/s13063-021-05873-7. PMID 34895296
Identifiers
NCT: NCT06581302 · 2023-TX-002