Recruiting

MST vs. ECT

Sponsor:

Centre for Addiction and Mental Health

Code:

NCT06672588

Conditions

Treatment Resistant Schizophrenia

Schizophrenia

Schizoaffective Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Magnetic Seizure Therapy (MST)

Electroconvulsive Therapy (ECT)

Study Details

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

Study ID

NCT06672588

Start date

Apr 22, 2025

Status verified date

Jan, 2026

Completion date

Nov, 2028

Anticipated

Primary completion date

Nov, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Magnetic Seizure Therapy (MST)

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

active comparator: Electroconvulsive Therapy (ECT)

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

Interventions

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.

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.

Primary outcome measure

  • Brief Psychiatric Rating Scale (BPRS) Response (18-Version) [ Time Frame: Greater than 8 treatments (2.5 weeks) ]
  • MATRICS™ Consensus Cognitive Battery (MCCB) [ Time Frame: Greater than 8 treatments (2.5 weeks) ]

Central Contacts and Locations

Central contacts

Locations

University of British Columbia Hospital

Recruiting

Vancouver, British Columbia, Canada, V6T 2A1

Contacts

Principal Investigator:

Fidel Vila-Rodriguez, M.D., Ph.D

Centre for Addiction and Mental Health

Recruiting

Toronto, Ontario, Canada, M6J 1H4

Contacts

Principal Investigator:

Daniel Blumberger, M.D., MSc.

More Information

Sponsor

Centre for Addiction and Mental Health

Last update posted

Feb 3, 2026

Last verified

Jan, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Centre for Addiction and Mental Health on 2026-02-03.