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| Name | Class |
|---|---|
| University of British Columbia | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Magnetic Seizure Therapy (MST) | Experimental | MST treatments will be administered using the MagPro MST with Cool TwinCoil. |
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| Electroconvulsive Therapy (ECT) | Active Comparator | ECT treatments will be administered using the MECTA spECTrum 5000Q or MECTA Sigma. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnetic Seizure Therapy (MST) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Greater than 8 treatments (2.5 weeks) |
| MATRICSâ„¢ 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. | Greater than 8 treatments (2.5 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Greater than 8 treatments (2.5 weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daniel Blumberger, MD., MSc. | Contact | 416-535-8501 | 33662 | daniel.blumberger@camh.ca |
| Hannah Taalman, MSc. | Contact | 416-535-8501 | 30990 | hannah.taalman@camh.ca |
| Name | Affiliation | Role |
|---|---|---|
| Daniel Blumberger, M.D., MSc. | Centre for Addiction and Mental Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of British Columbia Hospital | Recruiting | Vancouver | British Columbia | V6T 2A1 | Canada |
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| Label | URL |
|---|---|
| Information About Research At the Centre for Addiction and Mental Health | View source |
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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.
Beginning 12 months and ending 3 years after publication of the primary outcome paper.
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| ID | Term |
|---|---|
| D000090663 | Schizophrenia, Treatment-Resistant |
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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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.
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Participants will be randomized into the study using a permuted block method with a random number generator. The study statistician will prepare the randomization scheme. The block size will be fixed and study personnel will be blinded to the randomization block size.
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| Electroconvulsive Therapy (ECT) | Device | 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. |
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| 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. | Greater than 8 treatments (2.5 weeks) |
| Autobiographical Memory Test (AMT) | Interviewer-rated measure with 10 items that indexes autobiographical memory recall and specificity. | 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. | Greater than 8 treatments (2.5 weeks) |
| Centre for Addiction and Mental Health | Recruiting | Toronto | Ontario | M6J 1H4 | Canada |
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