Magnetic Seizure Therapy for Psychotic Disorders

Shanghai Jiao Tong University School of Medicine

Status: Enrolling

Conditions: Psychotic Disorders

Treatments: Device: Magnetic seizure therapy by Magnetic stimulator; Drug: Antipsychotic medications (such as olanzpine, risperidone, aripiprazole, quetiapine, amisulpride, etc)

Study type: Interventional

Funder types: Other

Identifiers

NCT06581302

2023-TX-002

Details and patient eligibility

About

This trial aims to evaluate the efficacy and safety of Magnetic Seizure Therapy (MST) as an augmentation of antipsychotic medications for psychosis.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Magnetic seizure therapy plus antipsychotics

Experimental group

Description:

The patients will receive antipsychotic drugs plus MST during the first 2 weeks. A TwinCoil of MagPro XP will be positioned centrally over the frontal cortex in the midline position. The output power of MagPro XP is set to 100%, and stimulation frequency is 100 Hz. For MST titration, the first step is given at a 5-second train duration; if there is no seizure, the duration is increased to 10 seconds with a maximum limit of 10 seconds. The subsequent MST treatment will be maintained at 10 seconds. This procedure will be carried out under anesthesia. A total of up to 10 treatments will be administered to participants, usually five times a week, for 2 weeks.

Treatment:

Device: Magnetic seizure therapy by Magnetic stimulator

antipsychotic drugs

Active Comparator group

Description:

The patients will receive second-generation antipsychotic drugs without MST or ECT during the first 2 weeks.

Treatment:

Drug: Antipsychotic medications (such as olanzpine, risperidone, aripiprazole, quetiapine, amisulpride, etc)