Magnetic Seizure Therapy for Schizophrenia - Trial (MAST)

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).

Study Overview

• Status: Recruiting
• Conditions: Schizophrenia; Schizoaffective Disorder; Treatment Resistant Schizophrenia
• Intervention / Treatment: Device: Magnetic Seizure Therapy (MST); Device: Electroconvulsive Therapy (ECT)

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daniel Blumberger, MD., MSc.; Phone Number: 33662 416-535-8501; Email: daniel.blumberger@camh.ca
• Study Contact Backup: Name: Hannah Taalman, MSc.; Phone Number: 30990 416-535-8501; Email: hannah.taalman@camh.ca

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6T 2A1
      • Recruiting
      • University of British Columbia Hospital
      • Contact: Anabelle McPherson; Phone Number: 604-827-1361; Email: ninet.lab@ubc.ca
      • Principal Investigator: Fidel Vila-Rodriguez, M.D., Ph.D
  • Ontario
    • Toronto, Ontario, Canada, M6J 1H4
      • Recruiting
      • Centre for Addiction and Mental Health
      • Contact: Hannah Taalman, MSc.; Phone Number: 30990 416-535-8501; Email: hannah.taalman@camh.ca
      • Contact: Hanna Abraham; Phone Number: 30772 416-535-8501; Email: hanna.abraham@camh.ca
      • Principal Investigator: Daniel Blumberger, M.D., MSc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. are inpatients or outpatients;
2. demonstrate capacity to consent according to the MacArthur competence assessment tool for clinical research (MacCAT-CR);
3. have a DSM-5 diagnosis of Schizophrenia or Schizoaffective Disorder for at least 2 years, as determined by the MINI International Neuropsychiatric Interview - Version 7 (MINI-7.0);
4. are 18 years of age or older;
5. have demonstrated resistance to at least 2 antipsychotics of 600 mg of chlorpromazine equivalents for at least 6 weeks;
6. have a BPRS score at baseline of at least moderate severity (>4) on one of the four psychotic items (i.e., hallucinatory behavior, suspiciousness, conceptual disorganization, unusual thought content) or at least 12 on these 4 items combined;
7. are considered to be appropriate to receive convulsive therapy as assessed by an ECT attending psychiatrist and a consultant anaesthesiologist;
8. are on an antipsychotic at an adequate dose and are agreeable to keeping their current antipsychotic treatment constant during the acute phase of the intervention;
9. are able to adhere to the intervention schedule;
10. meet the MST safety criteria;
11. If a woman of child-bearing potential: is willing to provide a negative pregnancy test and agrees not to become pregnant during trial participation.

Exclusion Criteria:

1. have a history of MINI diagnosis of a substance use disorder (other than nicotine and caffeine) within the past three months;
2. have a concomitant major unstable medical illness;
3. are pregnant or intend to get pregnant during the study;
4. have probable dementia based on study investigator assessment;
5. 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;
6. present with a serious medical condition,
7. 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;
8. require a benzodiazepine with a dose > lorazepam 2 mg/day or equivalent or any anticonvulsant due to the potential of these medications to limit the efficacy of both MST and ECT;
9. are unable to communicate in English fluently enough to complete the neuropsychological tests;
10. have a non-correctable clinically significant sensory impairment (i.e., cannot hear or see well enough to complete the neuropsychological tests).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Magnetic Seizure Therapy (MST); MST treatments will be administered using the MagPro MST with Cool TwinCoil.	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.; Other Names: MST
Active Comparator: Electroconvulsive Therapy (ECT); ECT treatments will be administered using the MECTA spECTrum 5000Q or MECTA Sigma.	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.; Other Names: ECT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brief Psychiatric Rating Scale (BPRS) Response (18-Version)	The scale is used to quantify psychiatric symptoms such as anxiety, depression, hallucinations, and unusual behaviours. The scale range is 18-126. A lower score indicates lower severity in anxiety, depression, and positive psychotic symptoms. A higher score indicates higher severity in negative and positive psychotic symptoms.	Greater than 8 treatments (2.5 weeks)
MATRICS™ Consensus Cognitive Battery (MCCB)	The MCCB Assessments: The battery of cognitive assessments (ten in total) is intended to provide evaluation of key cognitive domains relevant to schizophrenia and related disorders and be a measure of cognitive change before and after the treatment course. The ten tasks focus on the following cognitive domains: speed of processing; attention/vigilance; working memory; verbal learning; visual learning; reasoning and problem solving; and social cognition.	Greater than 8 treatments (2.5 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Scale for Suicidal Ideation (SSI)	This scale is used to assess the presence or absence of suicidal ideation and the degree of severity of suicidal ideas. The scale range is 0 - 38 (total score). Lower scores indicate lower severity of suicidal ideation (i.e., better outcome). Higher scores indicate higher severity of suicidal ideation (i.e., worse outcome).	Greater than 8 treatments (2.5 weeks)
The Calgary Depression Scale for Schizophrenia (CDSS)	CDSS is a nine item clinician rated outcome measure that assesses the level of depression in people with schizophrenia. It distinguishes depressive symptoms from negative positive and extrapyramidal symptoms. The scale range is 0 - 27. A lower score indicates lower severity in depressive symptoms. A higher score indicates higher severity in depressive symptoms.	Greater than 8 treatments (2.5 weeks)
Autobiographical Memory Test (AMT)	Interviewer-rated measure with 10 items that indexes autobiographical memory recall and specificity.	Greater than 8 treatments (2.5 weeks)
Montreal Cognitive Assessment (MoCA)	The MoCA is a 30-point screening test that takes approximately 10 minutes to administer. It assesses executive functioning, visuospatial abilities, memory, attention, working memory, language, and orientation.	Greater than 8 treatments (2.5 weeks)

Collaborators and Investigators

• Sponsor: Centre for Addiction and Mental Health
• Collaborators: University of British Columbia
• Investigators: Principal Investigator: Daniel Blumberger, M.D., MSc., Centre for Addiction and Mental Health

Publications and helpful links

Helpful Links

• Information About Research At the Centre for Addiction and Mental Health

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2025
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2028

Study Registration Dates

• First Submitted: November 1, 2024
• First Submitted That Met QC Criteria: November 1, 2024
• First Posted (Actual): November 4, 2024

Study Record Updates

• Last Update Posted (Actual): February 3, 2026
• Last Update Submitted That Met QC Criteria: January 30, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Schizophrenia; Schizoaffective Disorder; Electroconvulsive Therapy; Magnetic Seizure Therapy; Convulsive Therapy; Treatment Resistant Schizophrenia
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Schizophrenia, Treatment-Resistant; Schizophrenia; Psychotic Disorders
• Other Study ID Numbers: 2105

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data from this project will be used for future research by internal and external project collaborators. Deidentified participant data along with data dictionaries will be made available and to gain access data requestors will need to sign a data access agreement.
• IPD Sharing Time Frame: Beginning 12 months and ending 3 years after publication of the primary outcome paper.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No