Depressive DisorderNCT01596608
Magnetic Seizure Therapy (MST) for Treatment Resistant Depression, Schizophrenia, and Obsessive Compulsive Disorder
A study testing Magnetic Seizure Therapy (MagPro MST) in people with Depressive Disorder and Schizophrenia, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial summary
Electroconvulsive therapy (ECT) has unparalleled efficacy in treating severe depression, and is also useful in treatment-refractory cases of schizophrenia and obsessive compulsive disorder (OCD). However, its use is limited by significant adverse effects on memory and cognition. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Depressive Disorder, Schizophrenia, Schizoaffective Disorder
- What is being tested?
- Magnetic Seizure Therapy (MagPro MST)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2012to Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ages 18 to 85
- DSM-IV diagnosis of major depressive episode with or without psychotic features in the context of MDD or bipolar disorder; OCD or Schizophrenia
- 24-item HRSD score of ≥ 21 (for depression subjects)
- 18-item BPRS score of ≥ 37 (for schizophrenia subjects)
- Y-BOCS score of ≥ 16 (for OCD subjects)
- demonstrate capacity to give informed consent
- are a Canadian resident
Who cannot join
- have an unstable medical and/or neurological condition
- are currently pregnant or lactating
- are not considered sufficiently well to undergo general anesthesia for any reason
- have a cardiac pacemaker, cochlear implant, implanted electronic device or non-electric metallic implant
- are taking a benzodiazepine at a dose greater than lorazepam 2mg or equivalent
- are taking any non-benzodiazepine anticonvulsant
Show all 10Show fewer
- have active substance misuse or dependence within the past 3 months
- have a current diagnosis of delirium, dementia or another cognitive disorder secondary to a general medical condition
- have a co-morbid borderline personality disorder and/or antisocial personality disorder
- have had a history of any suicide attempts in the past 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Tolerability of Magnetic Seizure Therapy (MST) as an Alternative to Electroconvulsive Therapy (ECT) for Treatment Resistant Depression, Schizophrenia, and Obsessive Compulsive Disorder
Electroconvulsive therapy (ECT) has unparalleled efficacy in treating severe depression, and is also useful in treatment-refractory cases of schizophrenia and obsessive compulsive disorder (OCD). However, its use is limited by significant adverse effects on memory and cognition. In addition, ECT cannot be precisely targeted, since it relies on unpredictable pathways of electrical conduction through the brain. Magnetic seizure therapy (MST) is currently under investigation as a targetable, cognition-sparing alternative to ECT. MST uses magnetic fields rather than electrical stimuli for seizure induction, dramatically reducing the passage of induced current through undesired brain regions. 10 years of experimental studies have established the safety of MST in animal and human subjects. This pilot study will investigate whether MST has similar efficacy to ECT, with fewer cognitive side effects, in patients with severe depression, schizophrenia, and OCD.
Read the detailed description
Although ECT is effective against severe depression, psychosis, and OCD, it also produces significant impairments of autobiographical memory and other cognitive functions. These side effects limit the acceptability and tolerability of ECT in many patient populations. They also limit the number of treatments that can be administered in a course of ECT, leading to high relapse rates once ECT is discontinued. In animal studies, MST has been shown to have far fewer adverse cognitive effects than ECT. In small human studies, humans have shown faster subjective and objective recovery of orientation after MST than with ECT. However, the precise degree of cognitive sparing in MST versus ECT has yet to be established. Likewise, the comparative efficacy of MST versus ECT in severe depression, schizophrenia, and OCD remains to be seen. The investigators aim to determine whether MST spares autobiographical memory and other cognitive functions, while retaining comparable efficacy to that of ECT.
Objective 1: To compare the efficacy of MST and ECT in treating patients with severe depression, schizophrenia, and OCD.
Hypothesis 1: MST will have equivalent efficacy to ECT on objective measures of mood, schizophrenia, and OCD symptoms.
Objective 2: To compare the effects of MST and ECT on autobiographical memory and other cognitive functions in patients with severe depression, schizophrenia, schizoaffective disorder and OCD.
Hypothesis 2: MST will have significantly lower adverse effects on objective measures of autobiographical memory and other cognitive functions in patients with severe depression, schizophrenia, and OCD.
Objective 3: To compare the changes in brain function that result from MST and ECT.
Hypothesis 3: Both MST and ECT will produce changes in functional brain activity consistent with antidepressant response, antipsychotic response, and antiobsessive response, along with a sparing of cognitive functions.
The discovery of a viable alternative to ECT, with equivalent efficacy but fewer side effects, would have a transformative effect on the treatment of several forms of severe mental illness. At present, many patients who could benefit from ECT do not pursue this treatment due to concerns about cognitive side effects, as well as the enduring social stigma of ECT itself. In addition, many patients who have benefited from ECT are obliged to discontinue this effective treatment because of mounting cognitive side effects; high rates of relapse then ensue.
If MST could be shown to spare autobiographical memory and other forms of cognition, many more patients would be willing to take advantage of the treatment. They would also be able to continue the treatment, when effective, for longer periods. The potential result would be a dramatic improvement in the rates of remission and relapse for patients with severe depression and other forms of mental illness.
- Conditions
- Depressive Disorder, Schizophrenia, Schizoaffective Disorder, Obsessive-Compulsive Disorder
- Being tested
- Magnetic Seizure Therapy (MagPro MST)
- Keywords
- Magnetic seizure therapy, Treatment resistance, Open-label trial, Treatment resistant depression, Treatment resistant schizophrenia, Treatment resistant obsessive-compulsive disorder
- Medical subject headings
- Depressive Disorder, Schizophrenia, Psychotic Disorders, Obsessive-Compulsive Disorder, Depressive Disorder, Treatment-Resistant, Schizophrenia, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Seizure Therapy (MagPro MST)Device
Also called MagPro MST (Tonica Elektronik A/S, Denmark)
100% machine output at between 25 and 100 Hz, with coil directed over frontal or vertex brain regions, until adequate seizure achieved. Six treatment sessions, at a frequency of two or three times per week will be administered. If subjects fail to achieve the pre-defined criteria of remission at that point, the dose will be increased to the maximal stimulator output and 3 additional treatment sessions will be provided. This will be repeated a total of 5 times (i.e., maximum treatment number is 24). 24 treatments is typically longer that a conventional ECT treatment course. However, evidence does suggest that longer treatment courses may be needed with MST, particularly in more treatment resistant psychiatric conditions such as OCD and schizophrenia.
| Study group | Role | What they receive |
|---|---|---|
| Magnetic Seizure Therapy | Experimental | Not described Receives: Device: Magnetic Seizure Therapy (MagPro MST) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score on rating scale that corresponds to diagnosis: i) Hamilton Rating Scale for Depression, 24-item (HRSD-24); or ii) Yale-Brown Obsessive Compulsive Scale (Y-BOCS); or iii) Brief Psychiatric Rating Scale (BPRS)
- The HRSD-24 is a semi-structured, clinician-administered scale used to assessed the severity of depressive symptoms. ii) The Y-BOCS is a clinician-rated scale used to assess the severity of OCD symptoms. iii) The BPRS is a clinician-administered scale used to assess the severity of various psychiatric symptoms, such as depression, anxiety, hallucinations, and delusions. In this study, it will be used with participants diagnosed with schizophrenia.
Measured: Change from baseline in HRSD-24 / Y-BOCS / BPRS at date of symptom remission or date of the 24th treatment, whichever comes first, assessed up to 12 weeks
Score on rating scale that corresponds to diagnosis: i) HRSD-24; or ii) Y-BOCS; or iii) BPRS
Measured: Change from baseline in HRSD-24 / Y-BOCS / BPRS at 1 month after final treatment
Score on rating scale that corresponds to diagnosis: i) HRSD-24; or ii) Y-BOCS; or iii) BPRS
Measured: Change from baseline in HRSD-24 / Y-BOCS / BPRS at 2 months after final treatment
Score on rating scale that corresponds to diagnosis: i) HRSD-24; or ii) Y-BOCS; or iii) BPRS
Measured: Change from baseline in HRSD-24 / Y-BOCS / BPRS at 3 months after final treatment
Score on rating scale that corresponds to diagnosis: i) HRSD-24; or ii) Y-BOCS; or iii) BPRS
Measured: Change from baseline in HRSD-24 / Y-BOCS / BPRS at 6 months after final treatment
Secondary outcomes (4)
Cognitive Functioning
Improvement or sparing of cognitive functioning, as assessed by standard tests of episodic memory and non-memory cognitive functions.
Measured: Change from baseline in cognitive functioning at date of symptom remission or at date of 24th treatment, whichever comes first, assessed up to 12 weeks
Cognitive Functioning
Measured: Change from baseline in cognitive functioning at 6 months after final treatment
Neuroimaging (brain structure and activity)
Improvements in cortical thickness in subgenual cingulate cortex on T1 MRI voxel-based morphometry; improved anatomical connectivity between anterior hippocampus, subgenual cingulate cortex, and retrosplenial cortex on voxel-based comparative DTI tractography; subgenual and orbitofrontal functional connectivity to amygdala and ventral striatum on T2* fMRI BOLD signal covariation.
Measured: Changes from baseline in brain structure and activity within 48 hours after final treatment
Neuroimaging (brain structure and activity)
Improvements in cortical thickness in subgenual cingulate cortex on T1 MRI voxel-based morphometry; improved anatomical connectivity between anterior hippocampus, subgenual cingulate cortex, and retrosplenial cortex on voxel-based comparative DTI tractography; subgenual and orbitofrontal functional connectivity to amygdala and ventral striatum on T2* fMRI BOLD signal covariation.
Measured: Changes from baseline in brain structure and activity at 6 months after final treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2012 (estimated)
- Study startFeb 2012
- Primary completionJun 2019
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Centre for Addiction and Mental HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Collaborators
- University Health Network, Toronto
- Responsible party
- Principal investigator, Z. J. Daskalakis, Centre for Addiction and Mental Health
- Investigators
- Z. Jeffrey Daskalakis, MD, PhD., Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01596608
- Sponsor's protocol ID
- 145-2010
- Status last verified
- Jun 2020
- First submitted
- 8 May 2012
- Last updated
- 25 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tang VM, Blumberger DM, Throop A, McClintock SM, Voineskos D, Downar J, Knyahnytska Y, Mulsant BH, Fitzgerald PB, Daskalakis ZJ. Continuation Magnetic Seizure Therapy for Treatment-Resistant Unipolar or Bipolar Depression. J Clin Psychiatry. 2021 Oct 19;82(6):20m13677. doi: 10.4088/JCP.20m13677.
PubMed 34670025Weissman CR, Blumberger DM, Dimitrova J, Throop A, Voineskos D, Downar J, Mulsant BH, Rajji TK, Fitzgerald PB, Daskalakis ZJ. Magnetic Seizure Therapy for Suicidality in Treatment-Resistant Depression. JAMA Netw Open. 2020 Aug 3;3(8):e207434. doi: 10.1001/jamanetworkopen.2020.7434.
PubMed 32809030Tang VM, Blumberger DM, Dimitrova J, Throop A, McClintock SM, Voineskos D, Downar J, Knyahnytska Y, Mulsant BH, Fitzgerald PB, Daskalakis ZJ. Magnetic seizure therapy is efficacious and well tolerated for treatment-resistant bipolar depression: an open-label clinical trial. J Psychiatry Neurosci. 2020 Sep 1;45(5):313-321. doi: 10.1503/jpn.190098.
PubMed 31922372Tang VM, Blumberger DM, McClintock SM, Kaster TS, Rajji TK, Downar J, Fitzgerald PB, Daskalakis ZJ. Magnetic Seizure Therapy in Treatment-Resistant Schizophrenia: A Pilot Study. Front Psychiatry. 2018 Jan 16;8:310. doi: 10.3389/fpsyt.2017.00310. eCollection 2017.
PubMed 29387022
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Tolerability of Magnetic Seizure Therapy (MST) as an Alternative to Electroconvulsive Therapy (ECT) for Treatment Resistant Depression, Schizophrenia, and Obsessive Compulsive Disorder
- ClinicalTrials.gov ID
- NCT01596608
- Acronym / sponsor ID
- 145-2010
- Conditions
- Depressive Disorder, Schizophrenia, Schizoaffective Disorder, Obsessive-Compulsive Disorder
- Keywords
- Magnetic seizure therapy, Treatment resistance, Open-label trial, Treatment resistant depression, Treatment resistant schizophrenia, Treatment resistant obsessive-compulsive disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Collaborators
- University Health Network, Toronto
- Study start
- Feb 2012 (actual)
- Primary completion
- Jun 2019 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 11 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Electroconvulsive therapy (ECT) has unparalleled efficacy in treating severe depression, and is also useful in treatment-refractory cases of schizophrenia and obsessive compulsive disorder (OCD). However, its use is limited by significant adverse effects on memory and cognition. In addition, ECT cannot be precisely targeted, since it relies on unpredictable pathways of electrical conduction through the brain. Magnetic seizure therapy (MST) is currently under investigation as a targetable, cognition-sparing alternative to ECT. MST uses magnetic fields rather than electrical stimuli for seizure induction, dramatically reducing the passage of induced current through undesired brain regions. 10 years of experimental studies have established the safety of MST in animal and human subjects. This pilot study will investigate whether MST has similar efficacy to ECT, with fewer cognitive side effects, in patients with severe depression, schizophrenia, and OCD.
Detailed description
Although ECT is effective against severe depression, psychosis, and OCD, it also produces significant impairments of autobiographical memory and other cognitive functions. These side effects limit the acceptability and tolerability of ECT in many patient populations. They also limit the number of treatments that can be administered in a course of ECT, leading to high relapse rates once ECT is discontinued. In animal studies, MST has been shown to have far fewer adverse cognitive effects than ECT. In small human studies, humans have shown faster subjective and objective recovery of orientation after MST than with ECT. However, the precise degree of cognitive sparing in MST versus ECT has yet to be established. Likewise, the comparative efficacy of MST versus ECT in severe depression, schizophrenia, and OCD remains to be seen. The investigators aim to determine whether MST spares autobiographical memory and other cognitive functions, while retaining comparable efficacy to that of ECT.
Objective 1: To compare the efficacy of MST and ECT in treating patients with severe depression, schizophrenia, and OCD.
Hypothesis 1: MST will have equivalent efficacy to ECT on objective measures of mood, schizophrenia, and OCD symptoms.
Objective 2: To compare the effects of MST and ECT on autobiographical memory and other cognitive functions in patients with severe depression, schizophrenia, schizoaffective disorder and OCD.
Hypothesis 2: MST will have significantly lower adverse effects on objective measures of autobiographical memory and other cognitive functions in patients with severe depression, schizophrenia, and OCD.
Objective 3: To compare the changes in brain function that result from MST and ECT.
Hypothesis 3: Both MST and ECT will produce changes in functional brain activity consistent with antidepressant response, antipsychotic response, and antiobsessive response, along with a sparing of cognitive functions.
The discovery of a viable alternative to ECT, with equivalent efficacy but fewer side effects, would have a transformative effect on the treatment of several forms of severe mental illness. At present, many patients who could benefit from ECT do not pursue this treatment due to concerns about cognitive side effects, as well as the enduring social stigma of ECT itself. In addition, many patients who have benefited from ECT are obliged to discontinue this effective treatment because of mounting cognitive side effects; high rates of relapse then ensue.
If MST could be shown to spare autobiographical memory and other forms of cognition, many more patients would be willing to take advantage of the treatment. They would also be able to continue the treatment, when effective, for longer periods. The potential result would be a dramatic improvement in the rates of remission and relapse for patients with severe depression and other forms of mental illness.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Magnetic Seizure Therapy | Experimental | Device: Magnetic Seizure Therapy (MagPro MST) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ages 18 to 85
- DSM-IV diagnosis of major depressive episode with or without psychotic features in the context of MDD or bipolar disorder; OCD or Schizophrenia
- 24-item HRSD score of ≥ 21 (for depression subjects)
- 18-item BPRS score of ≥ 37 (for schizophrenia subjects)
- Y-BOCS score of ≥ 16 (for OCD subjects)
Key exclusion criteria (10 listed)
- have an unstable medical and/or neurological condition
- are currently pregnant or lactating
- are not considered sufficiently well to undergo general anesthesia for any reason
- have a cardiac pacemaker, cochlear implant, implanted electronic device or non-electric metallic implant
- are taking a benzodiazepine at a dose greater than lorazepam 2mg or equivalent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Seizure Therapy (MagPro MST)Also: MagPro MST (Tonica Elektronik A/S, Denmark)100% machine output at between 25 and 100 Hz, with coil directed over frontal or vertex brain regions, until adequate seizure achieved. Six treatment sessions, at a frequency of two or three times per week will be administered. If subjects fail to achieve the pre-defined criteria of remission at that point, the dose will be increased to the maximal stimulator output and 3 additional treatment sessions will be provided. This will be repeated a total of 5 times (i.e., maximum treatment number is 24). 24 treatments is typically longer that a conventional ECT treatment course. However, evidence does suggest that longer treatment courses may be needed with MST, particularly in more treatment resistant psychiatric conditions such as OCD and schizophrenia. | Device | Magnetic Seizure Therapy |
Primary outcome
Score on rating scale that corresponds to diagnosis: i) Hamilton Rating Scale for Depression, 24-item (HRSD-24); or ii) Yale-Brown Obsessive Compulsive Scale (Y-BOCS); or iii) Brief Psychiatric Rating Scale (BPRS)
Time frame: Change from baseline in HRSD-24 / Y-BOCS / BPRS at date of symptom remission or date of the 24th treatment, whichever comes first, assessed up to 12 weeks
i) The HRSD-24 is a semi-structured, clinician-administered scale used to assessed the severity of depressive symptoms. ii) The Y-BOCS is a clinician-rated scale used to assess the severity of OCD symptoms. iii) The BPRS is a clinician-administered scale used to assess the severity of various psychiatric symptoms, such as depression, anxiety, hallucinations, and delusions. In this study, it will be used with participants diagnosed with schizophrenia.
Score on rating scale that corresponds to diagnosis: i) HRSD-24; or ii) Y-BOCS; or iii) BPRS
Time frame: Change from baseline in HRSD-24 / Y-BOCS / BPRS at 1 month after final treatment
Score on rating scale that corresponds to diagnosis: i) HRSD-24; or ii) Y-BOCS; or iii) BPRS
Time frame: Change from baseline in HRSD-24 / Y-BOCS / BPRS at 2 months after final treatment
Score on rating scale that corresponds to diagnosis: i) HRSD-24; or ii) Y-BOCS; or iii) BPRS
Time frame: Change from baseline in HRSD-24 / Y-BOCS / BPRS at 3 months after final treatment
Score on rating scale that corresponds to diagnosis: i) HRSD-24; or ii) Y-BOCS; or iii) BPRS
Time frame: Change from baseline in HRSD-24 / Y-BOCS / BPRS at 6 months after final treatment
4 secondary outcomes
Cognitive Functioning
Time frame: Change from baseline in cognitive functioning at date of symptom remission or at date of 24th treatment, whichever comes first, assessed up to 12 weeks
Cognitive Functioning
Time frame: Change from baseline in cognitive functioning at 6 months after final treatment
Neuroimaging (brain structure and activity)
Time frame: Changes from baseline in brain structure and activity within 48 hours after final treatment
Neuroimaging (brain structure and activity)
Time frame: Changes from baseline in brain structure and activity at 6 months after final treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2020.
- Derived from this study: PubMed 34670025Tang VM, Blumberger DM, Throop A, McClintock SM, Voineskos D, Downar J, Knyahnytska Y, Mulsant BH, Fitzgerald PB, Daskalakis ZJ. Continuation Magnetic Seizure Therapy for Treatment-Resistant Unipolar or Bipolar Depression. J Clin Psychiatry. 2021 Oct 19;82(6):20m13677. doi: 10.4088/JCP.20m13677.
- Derived from this study: PubMed 32809030Weissman CR, Blumberger DM, Dimitrova J, Throop A, Voineskos D, Downar J, Mulsant BH, Rajji TK, Fitzgerald PB, Daskalakis ZJ. Magnetic Seizure Therapy for Suicidality in Treatment-Resistant Depression. JAMA Netw Open. 2020 Aug 3;3(8):e207434. doi: 10.1001/jamanetworkopen.2020.7434.
- Derived from this study: PubMed 31922372Tang VM, Blumberger DM, Dimitrova J, Throop A, McClintock SM, Voineskos D, Downar J, Knyahnytska Y, Mulsant BH, Fitzgerald PB, Daskalakis ZJ. Magnetic seizure therapy is efficacious and well tolerated for treatment-resistant bipolar depression: an open-label clinical trial. J Psychiatry Neurosci. 2020 Sep 1;45(5):313-321. doi: 10.1503/jpn.190098.
- Derived from this study: PubMed 29387022Tang VM, Blumberger DM, McClintock SM, Kaster TS, Rajji TK, Downar J, Fitzgerald PB, Daskalakis ZJ. Magnetic Seizure Therapy in Treatment-Resistant Schizophrenia: A Pilot Study. Front Psychiatry. 2018 Jan 16;8:310. doi: 10.3389/fpsyt.2017.00310. eCollection 2017.
- Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addiction teaching hospital, fully affiliated with the University of Toronto, and a PAHO/WHO Collaborating CentreLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Z. Jeffrey Daskalakis, MD, PhD. principal investigator
Centre for Addiction and Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic Seizure Therapy (MagPro MST) in people with Depressive Disorder and Schizophrenia, run by Centre for Addiction and Mental Health at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score on rating scale that corresponds to diagnosis: i) Hamilton Rating Scale for Depression, 24-item (HRSD-24); or ii) Yale-Brown Obsessive Compulsive Scale (Y-BOCS); or iii) Brief Psychiatric Rating Scale (BPRS) (time frame: Change from baseline in HRSD-24 / Y-BOCS / BPRS at date of symptom remission or date of the 24th treatment, whichever comes first, assessed up to 12 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01596608, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2020.