Magnetic Seizure Therapy for Schizophrenia - Trial

Launched by CENTRE FOR ADDICTION AND MENTAL HEALTH · Nov 1, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called Magnetic Seizure Therapy (MST) for people with Treatment Resistant Schizophrenia, a condition that has not improved with standard medications. MST is being explored as an alternative to a more traditional treatment known as electroconvulsive therapy (ECT). The trial aims to see how effective and safe MST is for patients, including those diagnosed with Schizophrenia or Schizoaffective Disorder for at least two years.

To participate, individuals must be at least 18 years old, currently receiving treatment, and have not responded to at least two different antipsychotic medications. They should also be able to agree to participate in the study and follow the treatment schedule. Participants will receive MST while continuing their current antipsychotic medication. This study is not yet recruiting participants, but it is an important opportunity for those who may have limited options for treatment. If you're interested in learning more or think you might qualify, please speak with your healthcare provider.

Gender

ALL

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 (\>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).