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New treatment option for Treatment Resistant Schizophrenia
Official title Magnetic Seizure Therapy for Schizophrenia - Trial
ClinicalTrials.gov ID: NCT06672588
What this study is testing
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- 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;
You likely can't join 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...
- present with a serious medical condition,
See the full eligibility criteria
- 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...
- 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.
- 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 how well it works 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).
The study team makes the final eligibility decision.
Where it's taking place
- Vancouver, British Columbia, Canada
- Toronto, Ontario, Canada
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Vancouver, British Columbia, Canada; Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.