NCT06672588

Magnetic Seizure Therapy for Schizophrenia - Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Centre for Addiction and Mental Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial aims to assess the clinical effects and tolerability of Magnetic Seizure Therapy (MST) as an alternative to electroconvulsive therapy (ECT) for Treatment Resistant Schizophrenia (RS).

Detailed description

The study will involve a randomized, double blind, non-inferiority clinical trial with two treatment arms conducted in two academic institutions (the Centre for Addiction and Mental Health (CAMH) in Toronto, and University of British Columbia (UBC) Hospital in Vancouver, British Columbia). The investigators will compare MST to right unilateral ultrabrief pulse ECT (RUL-UB-ECT). Treatment will be administered two to three days per week. Clinical response will be assessed with the 18-item Brief Psychiatric Rating Scale (BPRS). Response will be defined as greater than or equal to 40% decrease in the BPRS positive psychotic symptom subscale (4 items - hallucinatory, behavior, suspiciousness, conceptual disorganization, and unusual thought content). Patients who do not meet response criteria after 15 treatment sessions will be considered non-responders and will cease treatment sessions. The blind will not be broken to participants until the completion of the entire study.

Conditions

• Treatment Resistant Schizophrenia
• Schizophrenia
• Schizoaffective Disorder

Interventions

Type	Name	Description
DEVICE	Magnetic Seizure Therapy (MST)	MST treatment will be administered using the MagPro MST with a Cool TwinCoil over the frontal cortex in the midline position using 100 Hz stimulation at 100% machine output. Seizure threshold will follow prior protocols used for frontal MST. Patients will receive care and be managed by anaesthesia as per standard ECT practice.
DEVICE	Electroconvulsive Therapy (ECT)	In the ECT arm treatment, the MECTA spectrum 5000Q or MECTA sigma machine will be used. The ECT determination of seizure threshold and the adjustment of energy at subsequent sessions will be based on a standard published protocol. All participants will receive RUL-UB ECT at six times the seizure threshold. Patients will receive care and be managed by anaesthesia as per standard ECT practice.

Timeline

• Start date: 2025-04-22
• Primary completion: 2028-11-01
• Completion: 2028-11-01
• First posted: 2024-11-04
• Last updated: 2026-02-03

Locations

2 sites across 1 country: Canada