Clinical trial NCT06672588: Magnetic Seizure Therapy for Schizophrenia - Trial
Official title: Magnetic Seizure Therapy for Schizophrenia - Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Treatment Resistant Schizophrenia
Schizophrenia
Schizoaffective Disorder
Keywords: Schizophrenia
Schizoaffective Disorder
Treatment Resistant Schizophrenia
Electroconvulsive Therapy
Magnetic Seizure Therapy
Convulsive Therapy
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
Collaborators: name: University of British Columbia
First posted: 2024-11-04
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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).

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.

Eligibility criteria: 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 (\&gt;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 \&gt; 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).

Primary outcomes:
measure: Brief Psychiatric Rating Scale (BPRS) Response (18-Version)
timeFrame: Greater than 8 treatments (2.5 weeks)
measure: MATRICS™ Consensus Cognitive Battery (MCCB)
timeFrame: Greater than 8 treatments (2.5 weeks)
Secondary outcomes:
measure: Scale for Suicidal Ideation (SSI)
timeFrame: Greater than 8 treatments (2.5 weeks)
measure: The Calgary Depression Scale for Schizophrenia (CDSS)
timeFrame: Greater than 8 treatments (2.5 weeks)
measure: Autobiographical Memory Test (AMT)
timeFrame: Greater than 8 treatments (2.5 weeks)
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: Greater than 8 treatments (2.5 weeks)
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: University of British Columbia Hospital
state: British Columbia
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health
state: Ontario
Study officials:
affiliation: Centre for Addiction and Mental Health
name: Daniel Blumberger, M.D., MSc.
role: PRINCIPAL_INVESTIGATOR
References: