Clinical trial NCT06581302: Magnetic Seizure Therapy for Psychotic Disorders
Official title: Accelerated 100Hz Magnetic Seizure Therapy for Psychotic Disorders
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Psychotic Disorders
Keywords: Magnetic Seizure Therapy (MST)
psychotic disorders
longitudinal study
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2024-09-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Changes in Positive and Negative Symptom Scale (PANSS)
timeFrame: Baseline, 1 weeks, 2 weeks, 6 weeks
Secondary outcomes:
measure: Changes in cognition
timeFrame: Baseline, 1 weeks, 2 weeks
measure: Changes of ictal EEG feature
timeFrame: during each treatment
measure: Changes of cortical inhibition
timeFrame: baseline, 2 weeks
measure: Changes of brain grey matter
timeFrame: baseline, 2 weeks
measure: Changes in 24-item Hamilton Depression Rating Scale (HAM-D)
timeFrame: Baseline, 1 weeks, 2 weeks, 6 weeks
measure: Changes in Hamilton Anxiety Scale (HAMA)
timeFrame: Baseline, 1 weeks, 2 weeks, 6 weeks
measure: Changes in Clinical Global Impression (CGI) scale
timeFrame: Baseline, 2 weeks, 6 weeks
measure: Changes in Global Assessment of Functioning (GAF) scale
timeFrame: Baseline, 2 weeks, 6 weeks
measure: Changes in brain gamma band signal
timeFrame: Baseline, 2 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Mental Health Center
state: Shanghai
Study officials:
affiliation: Shanghai Mental Health Center
name: Jijun Wang, M.D, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.