Magnetic Seizure Therapy for Schizophrenia - Trial

NCT06672588 | Recruiting

• 1 other identifier: 2105
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief 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).

Conditions

Treatment Resistant Schizophrenia; Schizophrenia; Schizoaffective Disorder

Keywords

Schizophrenia; Schizoaffective Disorder; Treatment Resistant Schizophrenia; Electroconvulsive Therapy; Magnetic Seizure Therapy; Convulsive Therapy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Scale for Suicidal Ideation (SSI)

  Greater than 8 treatments (2.5 weeks)

• The Calgary Depression Scale for Schizophrenia (CDSS)

  Greater than 8 treatments (2.5 weeks)

• Autobiographical Memory Test (AMT)

  Greater than 8 treatments (2.5 weeks)

• Montreal Cognitive Assessment (MoCA)

  Greater than 8 treatments (2.5 weeks)

Study Arms (2)

Magnetic Seizure Therapy (MST)

EXPERIMENTAL

MST treatments will be administered using the MagPro MST with Cool TwinCoil.

Device: Magnetic Seizure Therapy (MST)

Electroconvulsive Therapy (ECT)

ACTIVE COMPARATOR

ECT treatments will be administered using the MECTA spECTrum 5000Q or MECTA Sigma.

Device: Electroconvulsive Therapy (ECT)

Interventions

Magnetic Seizure Therapy (MST) DEVICE

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.

Also known as: MST

Magnetic Seizure Therapy (MST)

Electroconvulsive Therapy (ECT) DEVICE

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.

Also known as: ECT

Electroconvulsive Therapy (ECT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• are inpatients or outpatients;
• demonstrate capacity to consent according to the MacArthur competence assessment tool for clinical research (MacCAT-CR);
• 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);
• are 18 years of age or older;
• have demonstrated resistance to at least 2 antipsychotics of 600 mg of chlorpromazine equivalents for at least 6 weeks;
• 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;
• are considered to be appropriate to receive convulsive therapy as assessed by an ECT attending psychiatrist and a consultant anaesthesiologist;
• 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;
• are able to adhere to the intervention schedule;
• meet the MST safety criteria;
• If a woman of child-bearing potential: is willing to provide a negative pregnancy test and agrees not to become pregnant during trial participation.

You may not qualify if:

• have a history of MINI diagnosis of a substance use disorder (other than nicotine and caffeine) within the past three months;
• have a concomitant major unstable medical illness;
• are pregnant or intend to get pregnant during the study;
• 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;
• present with a serious medical condition,
• 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;
• 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;
• are unable to communicate in English fluently enough to complete the neuropsychological tests;
• have a non-correctable clinically significant sensory impairment (i.e., cannot hear or see well enough to complete the neuropsychological tests).

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead
• University of British Columbia: collaborator

Study Sites (2)

University of British Columbia Hospital

Vancouver, British Columbia, V6T 2A1, Canada

RECRUITING

Centre for Addiction and Mental Health

Toronto, Ontario, M6J 1H4, Canada

RECRUITING

Related Links

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

MeSH Terms

Conditions

Schizophrenia, Treatment-Resistant; Schizophrenia; Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Daniel Blumberger, M.D., MSc.

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Blumberger, MD., MSc.

CONTACT

416-535-8501; daniel.blumberger@camh.ca

Hannah Taalman, MSc.

CONTACT

416-535-8501; hannah.taalman@camh.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participants will be randomized into the study using a permuted block method with a random number generator. The study statistician will prepare the randomization scheme. The block size will be fixed and study personnel will be blinded to the randomization block size.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study is a randomized, double blind, parallel-group clinical trial with two treatment arms conducted at two academic institutions. The aim is to recruit 80 participants in the hope of having 50 participants complete the study.

Study Record Dates

• First Submitted: November 1, 2024
• First Posted: November 4, 2024
• Study Start: April 22, 2025
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 12 months and ending 3 years after publication of the primary outcome paper.

Locations

CA (2)