Magnetic Seizure Therapy for Schizophrenia - Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre for Addiction and Mental Health
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Magnetic Seizure Therapy (MST)
DeviceMST 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)
DeviceIn 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.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Magnetic Seizure Therapy (MST)Experimental treatment 1 intervention
Group B: Electroconvulsive Therapy (ECT)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Greater than 8 treatments (2.5 weeks)2
MATRICS™ 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.
Time frame
Greater than 8 treatments (2.5 weeks)Secondary outcomes
1
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).
Time frame
Greater than 8 treatments (2.5 weeks)2
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.
Time frame
Greater than 8 treatments (2.5 weeks)3
Autobiographical Memory Test (AMT)
Interviewer-rated measure with 10 items that indexes autobiographical memory recall and specificity.
Time frame
Greater than 8 treatments (2.5 weeks)4
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.
Time frame
Greater than 8 treatments (2.5 weeks)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Centre for Addiction and Mental Health
Lead sponsor
University of British Columbia
Collaborator
Source ClinicalTrials.gov