Treatment Resistant SchizophreniaMASTNCT06672588
Magnetic Seizure Therapy for Schizophrenia - Trial
A study testing Magnetic Seizure Therapy (MST) and Electroconvulsive Therapy (ECT) in people with Treatment Resistant Schizophrenia and Schizophrenia, run by Centre for Addiction and Mental Health at 2 sites in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Treatment Resistant Schizophrenia, Schizophrenia, Schizoaffective Disorder
- What is being tested?
- Magnetic Seizure Therapy (MST) and Electroconvulsive Therapy (ECT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesCanada
- Study dates
- 22 Apr 2025to Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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,
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- 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).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Recruiting
Centre for Addiction and Mental Health
Toronto, Ontario, M6J 1H4
Hanna Abraham, 416-535-8501 ext. 30772, hanna.abraham@camh.ca
Hannah Taalman, MSc., 416-535-8501 ext. 30990, hannah.taalman@camh.ca
- Recruiting
University of British Columbia Hospital
Vancouver, British Columbia, V6T 2A1
Anabelle McPherson, 604-827-1361, ninet.lab@ubc.ca
Fidel Vila-Rodriguez, M.D., Ph.D
About this study
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).
Read the 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.
- Being tested
- Magnetic Seizure Therapy (MST), Electroconvulsive Therapy (ECT)
- Keywords
- Schizophrenia, Schizoaffective Disorder, Treatment Resistant Schizophrenia, Electroconvulsive Therapy, Magnetic Seizure Therapy, Convulsive Therapy
- Medical subject headings
- Schizophrenia, Treatment-Resistant, Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Seizure Therapy (MST)Device
Also called 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.
Electroconvulsive Therapy (ECT)Device
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| Magnetic Seizure Therapy (MST) | Experimental | MST treatments will be administered using the MagPro MST with Cool TwinCoil. Receives: Device: Magnetic Seizure Therapy (MST) |
| Electroconvulsive Therapy (ECT) | Active comparator | ECT treatments will be administered using the MECTA spECTrum 5000Q or MECTA Sigma. Receives: Device: Electroconvulsive Therapy (ECT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Greater than 8 treatments (2.5 weeks)
Secondary outcomes (4)
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).
Measured: 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.
Measured: Greater than 8 treatments (2.5 weeks)
Autobiographical Memory Test (AMT)
Interviewer-rated measure with 10 items that indexes autobiographical memory recall and specificity.
Measured: 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.
Measured: Greater than 8 treatments (2.5 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start22 Apr 2025
- Primary completionNov 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment Resistant SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Collaborators
- University of British Columbia
- Responsible party
- Sponsor
- Investigators
- Daniel Blumberger, M.D., MSc., Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06672588
- Sponsor's protocol ID
- 2105
- Acronym
- MAST
- Status last verified
- Jan 2026
- First submitted
- 1 Nov 2024
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Seizure Therapy for Schizophrenia - Trial
- ClinicalTrials.gov ID
- NCT06672588
- Acronym / sponsor ID
- MAST / 2105
- Keywords
- Schizophrenia, Schizoaffective Disorder, Treatment Resistant Schizophrenia, Electroconvulsive Therapy, Magnetic Seizure Therapy, Convulsive Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Collaborators
- University of British Columbia
- Study start
- 22 Apr 2025 (actual)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 4 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Magnetic Seizure Therapy (MST) | Experimental | Device: Magnetic Seizure Therapy (MST)MST treatments will be administered using the MagPro MST with Cool TwinCoil. |
| Electroconvulsive Therapy (ECT) | Active comparator | Device: Electroconvulsive Therapy (ECT)ECT treatments will be administered using the MECTA spECTrum 5000Q or MECTA Sigma. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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;
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Seizure Therapy (MST)Also: MSTMST 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 | Magnetic Seizure Therapy (MST) |
| Electroconvulsive Therapy (ECT)Also: ECTIn 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. | Device | Electroconvulsive Therapy (ECT) |
Primary outcome
Brief Psychiatric Rating Scale (BPRS) Response (18-Version)
Time frame: Greater than 8 treatments (2.5 weeks)
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.
MATRICS™ Consensus Cognitive Battery (MCCB)
Time frame: Greater than 8 treatments (2.5 weeks)
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.
4 secondary outcomes
Scale for Suicidal Ideation (SSI)
Time frame: Greater than 8 treatments (2.5 weeks)
The Calgary Depression Scale for Schizophrenia (CDSS)
Time frame: Greater than 8 treatments (2.5 weeks)
Autobiographical Memory Test (AMT)
Time frame: Greater than 8 treatments (2.5 weeks)
Montreal Cognitive Assessment (MoCA)
Time frame: Greater than 8 treatments (2.5 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Information About Research At the Centre for Addiction and Mental HealthLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Treatment Resistant Schizophrenia
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Reduction of Auditory-Verbal Hallucinations in Schizophrenia Through Cortical Neuromodulation
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Treatment Resistance in Psychiatric Disorders: the Search for Biological Markers Predictive of Response to Treatment
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Effects of Nitraria Retusa Infusion on Clozapine-induced Metabolic Side Effects
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RecruitingPhase 3
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Treatment-resistant Schizophrenia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Daniel Blumberger, M.D., MSc. principal investigator
Centre for Addiction and Mental Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic Seizure Therapy (MST) and Electroconvulsive Therapy (ECT) in people with Treatment Resistant Schizophrenia and Schizophrenia, run by Centre for Addiction and Mental Health at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel Blumberger, MD., MSc. (416-535-8501 ext. 33662, daniel.blumberger@camh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief Psychiatric Rating Scale (BPRS) Response (18-Version) (time frame: Greater than 8 treatments (2.5 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026; AzTrials last refreshed its copy on 26 Oct 2026.