Bipolar DepressionNCT04427137
Accelerated LFR for Bipolar Patients During the COVID-19 Pandemic
A study testing MagPro X100 Stimulator, B70 Fluid-Cooled Coil in people with Bipolar Depression, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial summary
The current study aims to assess the feasibility, acceptance and clinical outcomes of a practical high-dose LFR protocol, including tapering treatments and symptom-based relapse prevention treatments, in patients with bipolar depression previously responsive to ECT and patients needing urgent treatment due to symptom… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bipolar Depression
- What is being tested?
- MagPro X100 Stimulator, B70 Fluid-Cooled Coil
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteCanada
- Study dates
- 9 Jun 2020to 9 Nov 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Currently are experiencing a bipolar depressive episode (bipolar disorder type 1 or 2) based on the MINI with or without psychotic symptoms
- Have previous response to ECT or high symptom severity warranting acute ECT in the opinion of one of the brain stimulation psychiatrists
- Are over the age of 18
- Pass the TMS adult safety screening (TASS) questionnaire
- Are voluntary and competent to consent to treatment
Who cannot join
- have a Mini-International Neuropsychiatric Interview (MINI) confirmed diagnosis of substance dependence or abuse within the last 1 month
- Currently experiencing a mixed or manic episode (YMRS >12)
- have a concomitant major unstable medical illness, cardiac pacemaker or implanted medication pump
- have a lifetime Mini-International Neuropsychiatric Interview (MINI) diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder
- have any significant neurological disorder or insult including, but not limited to: any condition likely to be associated with increased intracranial pressure, space occupying brain lesion, any history of seizure except those therapeutically induced by ECT or a febrile seizure of infancy or single seizure related to a known drug related event, cerebral aneurysm, significant head trauma with loss of consciousness for greater than 5 minutes
- 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
- currently take more than lorazepam 2 mg daily (or equivalent) or any dose of an anticonvulsant due to the potential to limit rTMS efficacy
- Lack of response to accelerated course of rTMS in the past
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Novel and Practical Accelerated Low-frequency Right-sided Stimulation Protocol as a Substitute for Patients With Bipolar Depression Needing Electroconvulsive Therapy During the COVID-19 Pandemic
The current study aims to assess the feasibility, acceptance and clinical outcomes of a practical high-dose LFR protocol, including tapering treatments and symptom-based relapse prevention treatments, in patients with bipolar depression previously responsive to ECT and patients needing urgent treatment due to symptom severity during the COVID-19 pandemic.
Read the detailed description
Treatment resistant bipolar depression is a leading cause of disability and socioeconomic burden of disease, and current treatment options all suffer from critical deficiencies of efficacy, capacity, or tolerability, especially given the current COVID-19 pandemic. rTMS and aLFR in particular has the potential to overcome many of these deficiencies, and is safe and well-tolerated. Taken together with the reported findings of other groups, aLFR may be feasible, tolerable, and capable of achieving comparable and potentially better remission rates than longer 20 to 30-day courses and it may also be beneficial to taper treatments and use symptom-based relapse prevention treatments in an aLFR protocol. Importantly, our pilot data in two patients previously responsive to ECT and data from the Cole et al. study suggest that accelerated rTMS may be a potential substitute for ECT as it may be possible to achieve remission in patients with severe depressive symptoms who would otherwise receive ECT. Furthermore, there is a burden of being able to provide care to as many people as possible based on severity of illness during the pandemic.
- Conditions
- Bipolar Depression
- Being tested
- MagPro X100 Stimulator, B70 Fluid-Cooled Coil
- Keywords
- bipolar depression, transcranial magnetic stimulation, treatment resistance, low-frequency right-side stimulation
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MagPro X100 Stimulator, B70 Fluid-Cooled CoilDevice
Treatment will occur 8 times per treatment day (50 min pause between treatments). Each treatment session will consist of a single LFR treatment, with 360 pulses of LFR delivered in one continuous train of 6 minutes at 1Hz at 120% of the patient's resting motor threshold.
| Study group | Role | What they receive |
|---|---|---|
| Accelerated LFR | Experimental | In the acute treatment phase, treatment will occur 8 times daily (50 min pause between treatments) on weekdays, until symptom remission is achieved (HRSD-24 score < to 10) or a maximum of 10 working days of daily treatment. In the tapering phase, treatments will be reduced to 2 treatment days per week for 2 weeks and then 1 treatment day per week for 2 weeks (4 weeks total). Patients that have responded to treatment will then enter the symptom-based relapse prevention phase including virtual check-in with study staff and a treatment schedule based on symptom level according to a modified relapse prevention algorithm that has been developed to prevent relapse after a successful course of ECT (known as the STABLE algorithm). The relapse prevention phase will last a maximum of 6 months. Receives: Device: MagPro X100 Stimulator, B70 Fluid-Cooled Coil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion achieving remission on Hamilton Rating Scale for Depresion 24-it (HRSD-24)
Less than or equal to 10
This scale is used to quantify the severity of symptoms of depression Scale range: 0-76 (total score) Lower scores indicate lower severity of depressive symptoms (i.e., better outcome) Higher scores indicate higher severity of depressive symptoms (i.e., worse outcome)
Measured: Up to 10 days (From screening/baseline to end of the acute treatment)
Secondary outcomes (16)
Change in Hamilton Rating Scale for Depresion 24-it (HRSD-24)
changes in scores
This scale is used to quantify the severity of symptoms of depression Scale range: 0-76 (total score) Lower scores indicate lower severity of depressive symptoms (i.e., better outcome) Higher scores indicate higher severity of depressive symptoms (i.e., worse outcome)
Measured: Up to 10 days (From screening/baseline to end of the acute treatment)
Response on Hamilton Rating Scale for Depresion 24-it (HRSD-24)
50% Reduction in score
This scale is used to quantify the severity of symptoms of depression Scale range: 0-76 (total score) Lower scores indicate lower severity of depressive symptoms (i.e., better outcome) Higher scores indicate higher severity of depressive symptoms (i.e., worse outcome)
Measured: Up to 10 days (From screening/baseline to end of the acute treatment)
Change in Young Mania Rating Scale (YMRS)
changes in scores
This scale is used to quantify the severity of symptoms of mania Scale range: 0-60 (total score) Lower scores indicate lower severity of manic symptoms (i.e., better outcome) Higher scores indicate higher severity of manic symptoms (i.e., worse outcome)
Measured: Up to 10 days (From screening/baseline to end of the acute treatment)
Remission on Patient Health Questionnaire (PHQ-9)
Less than or equal to 4
This scale is used to quantify the severity of symptoms of depression Scale range: 0-27 (total score) Lower scores indicate lower severity of depressive symptoms (i.e., better outcome) Higher scores indicate higher severity of depressive symptoms (i.e., worse outcome)
Measured: Up to 10 days (From screening/baseline to end of the acute treatment)
Response on Patient Health Questionnaire (PHQ-9)
50% Reduction in score
This scale is used to quantify the severity of symptoms of depression Scale range: 0-27 (total score) Lower scores indicate lower severity of depressive symptoms (i.e., better outcome) Higher scores indicate higher severity of depressive symptoms (i.e., worse outcome)
Measured: Up to 10 days (From screening/baseline to end of the acute treatment)
Change in Patient Health Questionnaire (PHQ-9)
changes in scores
This scale is used to quantify the severity of symptoms of depression Scale range: 0-27 (total score) Lower scores indicate lower severity of depressive symptoms (i.e., better outcome) Higher scores indicate higher severity of depressive symptoms (i.e., worse outcome)
Measured: Up to 10 days (From screening/baseline to end of the acute treatment)
Remission on General Anxiety Disorder 7 item (GAD-7)
Less than or equal to 4
This scale is used to quantify the severity of symptoms of anxiety Scale range: 0-21 (total score) Lower scores indicate lower severity of anxiety symptoms (i.e., better outcome) Higher scores indicate higher severity of anxiety symptoms (i.e., worse outcome)
Measured: Up to 10 days (From screening/baseline to end of the acute treatment)
Response on General Anxiety Disorder 7 item (GAD-7)
50% Reduction in score
This scale is used to quantify the severity of symptoms of anxiety Scale range: 0-21 (total score) Lower scores indicate lower severity of anxiety symptoms (i.e., better outcome) Higher scores indicate higher severity of anxiety symptoms (i.e., worse outcome)
Measured: Up to 10 days (From screening/baseline to end of the acute treatment)
Change in General Anxiety Disorder 7 item (GAD-7)
changes in scores
This scale is used to quantify the severity of symptoms of anxiety Scale range: 0-21 (total score) Lower scores indicate lower severity of anxiety symptoms (i.e., better outcome) Higher scores indicate higher severity of anxiety symptoms (i.e., worse outcome)
Measured: Up to 10 days (From screening/baseline to end of the acute treatment)
Remission on Beck Depression Inventory (BDI-II)
Less than or equal to 12
This scale is used to quantify the severity of symptoms of depression Scale range: 0-63 (total score) Lower scores indicate lower severity of depressive symptoms (i.e., better outcome) Higher scores indicate higher severity of depressive symptoms (i.e., worse outcome)
Measured: Up to 10 days (From screening/baseline to end of the acute treatment)
Response on Beck Depression Inventory (BDI-II)
50% Reduction in Score
This scale is used to quantify the severity of symptoms of depression Scale range: 0-63 (total score) Lower scores indicate lower severity of depressive symptoms (i.e., better outcome) Higher scores indicate higher severity of depressive symptoms (i.e., worse outcome)
Measured: Up to 10 days (From screening/baseline to end of the acute treatment)
Change on Beck Depression Inventory (BDI-II)
changes in scores
This scale is used to quantify the severity of symptoms of depression Scale range: 0-63 (total score) Lower scores indicate lower severity of depressive symptoms (i.e., better outcome) Higher scores indicate higher severity of depressive symptoms (i.e., worse outcome)
Measured: Up to 10 days (From screening/baseline to end of the acute treatment)
Remission on Beck Scale for Suicidal Ideation (SSI)
Score of 0
This scale is used to assess the presence or absence of suicidal ideation and the degree of severity of suicidal ideas Scale range: 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)
Measured: Up to 10 days (From screening/baseline to end of the acute treatment)
Change on Beck Scale for Suicidal Ideation (SSI)
changes in scores
This scale is used to assess the presence or absence of suicidal ideation and the degree of severity of suicidal ideas Scale range: 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)
Measured: Up to 10 days (From screening/baseline to end of the acute treatment)
Change in WHO Disability Assessment Schedule (WHODAS) Range 0-38
changes in scores
Measured: Up to 10 days (From screening/baseline to end of the acute treatment)
Proportion of Patients Maintaining Response During Relapse Prevention
Includes number of treatment days needed and number going on to receive ECT
Measured: 24 weeks (Tapering and Relapse prevention phase)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start9 Jun 2020
- Primary completion9 Jan 2022
- Study completion9 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DepressionStudies 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
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Blumberger, Centre for Addiction and Mental Health
- Investigators
- Daniel Blumberger, MD, Principal investigator, CAMH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04427137
- Sponsor's protocol ID
- 071-2020
- Status last verified
- Feb 2024
- First submitted
- 10 Jun 2020
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel and Practical Accelerated Low-frequency Right-sided Stimulation Protocol as a Substitute for Patients With Bipolar Depression Needing Electroconvulsive Therapy During the COVID-19 Pandemic
- ClinicalTrials.gov ID
- NCT04427137
- Acronym / sponsor ID
- 071-2020
- Conditions
- Bipolar Depression
- Keywords
- bipolar depression, transcranial magnetic stimulation, treatment resistance, low-frequency right-side stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Study start
- 9 Jun 2020 (actual)
- Primary completion
- 9 Jan 2022 (actual)
- Study completion
- 9 Nov 2022 (actual)
- First posted
- 11 Jun 2020 (actual)
- 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.
The current study aims to assess the feasibility, acceptance and clinical outcomes of a practical high-dose LFR protocol, including tapering treatments and symptom-based relapse prevention treatments, in patients with bipolar depression previously responsive to ECT and patients needing urgent treatment due to symptom severity during the COVID-19 pandemic.
Detailed description
Treatment resistant bipolar depression is a leading cause of disability and socioeconomic burden of disease, and current treatment options all suffer from critical deficiencies of efficacy, capacity, or tolerability, especially given the current COVID-19 pandemic. rTMS and aLFR in particular has the potential to overcome many of these deficiencies, and is safe and well-tolerated. Taken together with the reported findings of other groups, aLFR may be feasible, tolerable, and capable of achieving comparable and potentially better remission rates than longer 20 to 30-day courses and it may also be beneficial to taper treatments and use symptom-based relapse prevention treatments in an aLFR protocol. Importantly, our pilot data in two patients previously responsive to ECT and data from the Cole et al. study suggest that accelerated rTMS may be a potential substitute for ECT as it may be possible to achieve remission in patients with severe depressive symptoms who would otherwise receive ECT. Furthermore, there is a burden of being able to provide care to as many people as possible based on severity of illness during the pandemic.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Accelerated LFR | Experimental | Device: MagPro X100 Stimulator, B70 Fluid-Cooled CoilIn the acute treatment phase, treatment will occur 8 times daily (50 min pause between treatments) on weekdays, until symptom remission is achieved (HRSD-24 score < to 10) or a maximum of 10 working days of daily treatment. In the tapering phase, treatments will be reduced to 2 treatment days per week for 2 weeks and then 1 treatment day per week for 2 weeks (4 weeks total). Patients that have responded to treatment will then enter the symptom-based relapse prevention phase including virtual check-in with study staff and a treatment schedule based on symptom level according to a modified relapse prevention algorithm that has been developed to prevent relapse after a successful course of ECT (known as the STABLE algorithm). The relapse prevention phase will last a maximum of 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Currently are experiencing a bipolar depressive episode (bipolar disorder type 1 or 2) based on the MINI with or without psychotic symptoms
- Have previous response to ECT or high symptom severity warranting acute ECT in the opinion of one of the brain stimulation psychiatrists
- Are over the age of 18
- Pass the TMS adult safety screening (TASS) questionnaire
- Are voluntary and competent to consent to treatment
Key exclusion criteria (8 listed)
- have a Mini-International Neuropsychiatric Interview (MINI) confirmed diagnosis of substance dependence or abuse within the last 1 month
- Currently experiencing a mixed or manic episode (YMRS >12)
- have a concomitant major unstable medical illness, cardiac pacemaker or implanted medication pump
- have a lifetime Mini-International Neuropsychiatric Interview (MINI) diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder
- have any significant neurological disorder or insult including, but not limited to: any condition likely to be associated with increased intracranial pressure, space occupying brain lesion, any history of seizure except those therapeutically induced by ECT or a febrile seizure of infancy or single seizure related to a known drug related event, cerebral aneurysm, significant head trauma with loss of consciousness for greater than 5 minutes
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 |
|---|---|---|
| MagPro X100 Stimulator, B70 Fluid-Cooled CoilTreatment will occur 8 times per treatment day (50 min pause between treatments). Each treatment session will consist of a single LFR treatment, with 360 pulses of LFR delivered in one continuous train of 6 minutes at 1Hz at 120% of the patient's resting motor threshold. | Device | Accelerated LFR |
Primary outcome
Proportion achieving remission on Hamilton Rating Scale for Depresion 24-it (HRSD-24)
Time frame: Up to 10 days (From screening/baseline to end of the acute treatment)
Less than or equal to 10 This scale is used to quantify the severity of symptoms of depression Scale range: 0-76 (total score) Lower scores indicate lower severity of depressive symptoms (i.e., better outcome) Higher scores indicate higher severity of depressive symptoms (i.e., worse outcome)
16 secondary outcomes
Change in Hamilton Rating Scale for Depresion 24-it (HRSD-24)
Time frame: Up to 10 days (From screening/baseline to end of the acute treatment)
Response on Hamilton Rating Scale for Depresion 24-it (HRSD-24)
Time frame: Up to 10 days (From screening/baseline to end of the acute treatment)
Change in Young Mania Rating Scale (YMRS)
Time frame: Up to 10 days (From screening/baseline to end of the acute treatment)
Remission on Patient Health Questionnaire (PHQ-9)
Time frame: Up to 10 days (From screening/baseline to end of the acute treatment)
Response on Patient Health Questionnaire (PHQ-9)
Time frame: Up to 10 days (From screening/baseline to end of the acute treatment)
Change in Patient Health Questionnaire (PHQ-9)
Time frame: Up to 10 days (From screening/baseline to end of the acute treatment)
Remission on General Anxiety Disorder 7 item (GAD-7)
Time frame: Up to 10 days (From screening/baseline to end of the acute treatment)
Response on General Anxiety Disorder 7 item (GAD-7)
Time frame: Up to 10 days (From screening/baseline to end of the acute treatment)
Change in General Anxiety Disorder 7 item (GAD-7)
Time frame: Up to 10 days (From screening/baseline to end of the acute treatment)
Remission on Beck Depression Inventory (BDI-II)
Time frame: Up to 10 days (From screening/baseline to end of the acute treatment)
Response on Beck Depression Inventory (BDI-II)
Time frame: Up to 10 days (From screening/baseline to end of the acute treatment)
Change on Beck Depression Inventory (BDI-II)
Time frame: Up to 10 days (From screening/baseline to end of the acute treatment)
Remission on Beck Scale for Suicidal Ideation (SSI)
Time frame: Up to 10 days (From screening/baseline to end of the acute treatment)
Change on Beck Scale for Suicidal Ideation (SSI)
Time frame: Up to 10 days (From screening/baseline to end of the acute treatment)
Change in WHO Disability Assessment Schedule (WHODAS) Range 0-38
Time frame: Up to 10 days (From screening/baseline to end of the acute treatment)
Proportion of Patients Maintaining Response During Relapse Prevention
Time frame: 24 weeks (Tapering and Relapse prevention phase)
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 20 Feb 2024.
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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.
Daniel Blumberger, MD principal investigator
CAMH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MagPro X100 Stimulator, B70 Fluid-Cooled Coil in people with Bipolar Depression, 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 5 inclusion and 8 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 20 Feb 2024. 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?
Proportion achieving remission on Hamilton Rating Scale for Depresion 24-it (HRSD-24) (time frame: Up to 10 days (From screening/baseline to end of the acute treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Feb 2024.