Borderline Personality DisorderNCT03361826
Magnetic Seizure Therapy for the Treatment of Borderline Personality Disorder
A study testing MagPro MST with Cool TwinCoil and DBT in people with Borderline Personality Disorder, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial summary
Suicide is a major public health crisis for which effective new interventions are needed. An innovative new brain stimulation technique called magnetic seizure therapy (MST) shows promise for treating suicidal thinking in chronically depressed individuals. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Borderline Personality Disorder
- What is being tested?
- MagPro MST with Cool TwinCoil and DBT
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteCanada
- Study dates
- 17 Oct 2017to 24 Jun 2020
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- MST+DBT Group
- English-speaking and able to provide informed consent to participate in the study
- Female and between the ages 18 and 50 years
- Current DSM-IV (Diagnostic and statistical manual of mental disorders-IV) diagnosis of BPD based on the International Personality Disorder Examination BPD Section (IPDE-BPD)
- Current DSM-IV diagnosis of a non-psychotic, major depressive episode, as part of a broader diagnosis of MDD (single episode or recurrent episode), based on the Structured Clinical Interview for DSM-IV Axis I Disorders-Patient Edition (SCID-I/P)
- Score > 9 (equivalent to moderate-to-severe suicidal ideation) on the Modified Suicidal ideation Scale for at least the two weeks prior to enrolling in the study
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- Hamilton Rating Scale for Depression (HRSD-24) score > 22 (classified as Very Severe Depression)
- Failed to achieve a clinical response to adequate treatment trials of two or more antidepressants during the current depressive episode OR have been unable to tolerate at least two antidepressants as assessed by the Antidepressant Treatment History Form (ATHF)
- Deemed appropriate to receive ECT as assessed by an ECT attending psychiatrist and an anesthesiologist
- Meets the MST safety criteria
- Agreeable to keeping their current antidepressant treatment (if any) constant during the intervention (unless clinically indicated)
- Has a close family member, friend, partner, or qualified chaperone able and willing to accompany the patient home after each MST treatment session and
- Able to adhere to the intervention schedule.
- DBT-Only Group
- English-speaking and able to provide informed consent to participate in the study
- Female and between the ages 18 and 50 years
- Current DSM-IV diagnosis of BPD based on the International Personality Disorder Examination BPD Section (IPDE-BPD)
- Current DSM-5 diagnosis of a non-psychotic, major depressive episode, as part of a broader diagnosis of MDD (single episode or recurrent episode), based on the Structured Clinical Interview for DSM-IV Axis I Disorders--Patient Edition (SCID-I)
- Score > 9 (equivalent to moderate-to-severe suicidal ideation) on the Modified Suicidal ideation Scale for at least the two weeks prior to enrolling in the study
- Baseline Hamilton Rating Scale for Depression (HRSD-24) score > 22
- Failed to achieve a clinical response to adequate treatment trials of two or more antidepressants during the current depressive episode OR have been unable to tolerate at least two antidepressants as assessed by the Antidepressant Treatment History Form (ATHF)
- Agreeable to keeping their current antidepressant treatment (if any) constant during the study (unless clinically indicated)
Who cannot join
- MST+DBT Group
- Acute suicidal intent that requires hospitalization to protect harm to self
- Any unstable medical and/or neurological condition
- Currently pregnant or lactating, or intention to get pregnant during the duration of the study
- Not considered sufficiently physically healthy to undergo general anesthesia for any reason
- Any significant neurological disorder or condition likely to be associated with increased intracranial pressure or cognitive impairment (e.g., a space occupying brain lesion, a history of stroke, a cerebral aneurysm, a seizure disorder, Parkinson's disease, Huntington's chorea, multiple sclerosis)
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- Medical condition, medication, or laboratory abnormality that could cause a major depressive episode or significant cognitive impairment in the opinion of the investigator (e.g., hypothyroidism with low thyroid-stimulating hormone (TSH), rheumatoid arthritis requiring high dose prednisone, or Cushing's disease)
- Current diagnosis of delirium, dementia or another cognitive disorder secondary to a general medical condition
- Diagnosis of a developmental disorder (e.g. Down syndrome, autism-spectrum disorder)
- Non-correctable clinically significant sensory impairment (i.e., cannot hear or see well enough to complete the neuropsychological tests)
- Lower than eighth-grade reading level as assessed by the Wide Range Achievement Test-Fourth Edition
- Alcohol or substance use disorder (relating to opioids or cocaine) currently or within the past 1 month
- Diagnosis of a DSM-5 psychotic disorder
- Demonstrated a lack of response to ECT during the current or prior depressive episode.
- Requires a benzodiazepine with a dose equivalent to lorazepam 2 mg/day or higher or any anticonvulsant due to the potential of these medications to limit the efficacy of both MST and ECT
- 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
- Has sustained a moderate-to-severe head injury (defined as ≥ 20 min loss of consciousness and/or > 24 hrs post-traumatic amnesia); or
- Does not qualify for MRI scanning
- DBT-Only Group
- Acute suicidal intent that requires hospitalization to protect harm to self
- Any unstable medical and/or neurological condition
- Currently pregnant or lactating, or intention to get pregnant during the duration of the study
- Any significant neurological disorder or condition likely to be associated with increased intracranial pressure or cognitive impairment (e.g., a space occupying brain lesion, a history of stroke, a cerebral aneurysm, a seizure disorder, Parkinson's disease, Huntington's chorea, multiple sclerosis)
- Medical condition, medication, or laboratory abnormality that could cause a major depressive episode or significant cognitive impairment in the opinion of the investigator (e.g., hypothyroidism with low TSH, rheumatoid arthritis requiring high dose prednisone, or Cushing's disease)
- Current diagnosis of delirium, dementia or another cognitive disorder secondary to a general medical condition
- Diagnosis of a developmental disorder (e.g. Down syndrome, autism-spectrum disorder)
- Non-correctable clinically significant sensory impairment (i.e., cannot hear or see well enough to complete the neuropsychological tests)
- Lower than eighth-grade reading level as assessed by the Wide Range Achievement Test--Fourth Edition
- Alcohol or substance use disorder (relating to opioids or cocaine use) currently or within the past 1 month
- Diagnosis of a DSM-5 psychotic disorder
- 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
- Has sustained a moderate-to-severe head injury (defined as ≥ 20 min loss of consciousness and/or > 24 hrs post-traumatic amnesia)
- Does not qualify for MRI scanning
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Magnetic Seizure Therapy for the Treatment of Treatment-Resistant Depression and Suicidal Ideation in Borderline Personality Disorder
Suicide is a major public health crisis for which effective new interventions are needed. An innovative new brain stimulation technique called magnetic seizure therapy (MST) shows promise for treating suicidal thinking in chronically depressed individuals. Using a high-risk cohort of suicidal patients with borderline personality disorder (BPD) and treatment resistant major depressive disorder (MDD), this study will evaluate the effectiveness of MST for reducing suicidality and depressive symptoms in an open-label clinical trial of up to 15 treatment sessions. Based on research showing that functioning of the dorsolateral prefrontal cortex (DLPFC) may be disrupted in BPD and place individuals at risk for suicide, the DLPFC will be targeted for stimulation. Moderate-to-highly suicidal patients with BPD beginning dialectical behavioural therapy (DBT) will be recruited using a case-control design, comparing individuals receiving MST and DBT with matched patient control group receiving DBT alone.
Read the detailed description
MST is a novel modification of electroconvulsive therapy (ECT) with the potential for similar clinical effectiveness, fewer side-effects and a more rapid return of orientation and shorter duration of post-ictal confusion. In the proposed study, the investigators will evaluate the clinical effectiveness of MST for the treatment of treatment-resistant depression (TRD) and suicidal ideation in patients with BPD. The study will use a case-control design comparing symptom reports (depression severity and suicidal ideation) and cognitive functioning between outpatients receiving MST plus dialectical behavioral therapy (DBT) and matched patient controls receiving DBT alone. To evaluate potential biomarkers that may underlie the anticipated clinical benefits of MST, functional magnetic resonance imaging (fMRI) will be used to measure activation of the DLPFC and associated neural circuits subserving emotion regulation and cognitive functioning (e.g., impulse control, episodic memory) in BPD.
Objective 1: To evaluate the efficacy of MST as a treatment for suicidal ideation and TRD in BPD.
Hypothesis 1: MST will demonstrate substantial efficacy on objective measures of suicidal ideation and depression.
Objective 2: To evaluate the effects of MST on cognitive functioning in patients with BPD.
Hypothesis 2: MST will have limited, if any, effects on performance on standard neuropsychological measures of attention, memory and executive functioning in patients with BPD.
Objective 3: To explore potential neuroimaging-based biomarkers that may index any changes in suicidal ideation and depression that result from treatment with MST.
Hypothesis 3: On neuroimaging tasks assessing emotion processing and cognitive functioning, patients receiving DBT+MST will show increased activity in bilateral DLPFC after treatment relative to pre-treatment baseline activation, and more activation in this region than patients in DBT without concurrent MST (DBT-only).
- Conditions
- Borderline Personality Disorder
- Being tested
- MagPro MST with Cool TwinCoil, DBT
- Keywords
- Magnetic seizure therapy (MST), Treatment resistance, Open-label trial, Borderline Personality Disorder, Suicidal Ideation, Treatment-resistant depression, Dialectical behavior therapy (DBT), MST + DBT, Neuroimaging-based biomarkers
- Medical subject headings
- Borderline Personality Disorder, Suicidal Ideation, Depressive Disorder, Treatment-Resistant, Myeloproliferative Syndrome, Transient, Maple syrup urine disease, type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MagPro MST with Cool TwinCoilDevice
Also called Magnetic Seizure Therapy (MST)
MST treatments will be administered using the MagPro MST with Cool TwinCoil. The investigators will evaluate the effectiveness of MST for reducing suicidality and depressive symptoms in an open-label clinical trial of up to 15 treatment sessions. Moderate-to-highly suicidal patients with BPD beginning dialectical behavioural therapy (DBT) will be recruited using a case-control design, comparing individuals receiving MST and DBT with matched patient control group receiving DBT alone.
DBTBehavioural
Also called Dialectical behavior therapy (DBT)
Dialectical behavior therapy (DBT) is a specific type of cognitive-behavioral psychotherapy developed to help better treat borderline personality disorder. Moderate-to-highly suicidal patients with BPD beginning dialectical behavioural therapy (DBT) will be recruited using a case-control design, comparing individuals receiving MST and DBT with matched patient control group receiving DBT alone.
| Study group | Role | What they receive |
|---|---|---|
| DBT Only | Other | Dialectical behavior therapy (DBT) is a specific type of cognitive-behavioral psychotherapy developed to help better treat borderline personality disorder. Receives: Behavioral: DBT |
| MagPro MST with Cool TwinCoil + DBT | Experimental | MST treatments will be administered using the MagPro MST with Cool TwinCoil. Moderate-to-highly suicidal patients with BPD beginning dialectical behavioural therapy (DBT) will be recruited using a case-control design, comparing individuals receiving MST and DBT with matched patient control group receiving DBT alone. Receives: Device: MagPro MST with Cool TwinCoil; Behavioral: DBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in symptom severity of depression as measured by the Hamilton Rating Scale for Depression - 24
Hamilton Rating Scale for Depression (24-item version)
- 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: 5 weeks
Improvement in symptom severity of Suicidal Ideation as measured by the Modified Scale for Suicidal Ideation
Modified Scale for Suicidal Ideation
- This scale is used to assess the presence or absence of suicidal ideation and the degree of severity of suicidal ideas
- Scale range: 0-54 (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: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2017
- Study start17 Oct 2017
- Primary completion24 Jun 2020
- Study completion24 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Borderline Personality 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Using a case-control design, the investigators will compare individuals receiving MST and DBT with matched patient control group receiving DBT alone.
- Masking
- None (open label)
- Enrolment
- 27 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, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03361826
- Sponsor's protocol ID
- 053/2015
- Status last verified
- Feb 2025
- First submitted
- 31 Oct 2017
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Seizure Therapy for the Treatment of Treatment-Resistant Depression and Suicidal Ideation in Borderline Personality Disorder
- ClinicalTrials.gov ID
- NCT03361826
- Acronym / sponsor ID
- 053/2015
- Conditions
- Borderline Personality Disorder
- Keywords
- Magnetic seizure therapy (MST), Treatment resistance, Open-label trial, Borderline Personality Disorder, Suicidal Ideation, Treatment-resistant depression, Dialectical behavior therapy (DBT), MST + DBT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Study start
- 17 Oct 2017 (actual)
- Primary completion
- 24 Jun 2020 (actual)
- Study completion
- 24 Jun 2020 (actual)
- First posted
- 5 Dec 2017 (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.
Suicide is a major public health crisis for which effective new interventions are needed. An innovative new brain stimulation technique called magnetic seizure therapy (MST) shows promise for treating suicidal thinking in chronically depressed individuals. Using a high-risk cohort of suicidal patients with borderline personality disorder (BPD) and treatment resistant major depressive disorder (MDD), this study will evaluate the effectiveness of MST for reducing suicidality and depressive symptoms in an open-label clinical trial of up to 15 treatment sessions. Based on research showing that functioning of the dorsolateral prefrontal cortex (DLPFC) may be disrupted in BPD and place individuals at risk for suicide, the DLPFC will be targeted for stimulation. Moderate-to-highly suicidal patients with BPD beginning dialectical behavioural therapy (DBT) will be recruited using a case-control design, comparing individuals receiving MST and DBT with matched patient control group receiving DBT alone.
Detailed description
MST is a novel modification of electroconvulsive therapy (ECT) with the potential for similar clinical effectiveness, fewer side-effects and a more rapid return of orientation and shorter duration of post-ictal confusion. In the proposed study, the investigators will evaluate the clinical effectiveness of MST for the treatment of treatment-resistant depression (TRD) and suicidal ideation in patients with BPD. The study will use a case-control design comparing symptom reports (depression severity and suicidal ideation) and cognitive functioning between outpatients receiving MST plus dialectical behavioral therapy (DBT) and matched patient controls receiving DBT alone. To evaluate potential biomarkers that may underlie the anticipated clinical benefits of MST, functional magnetic resonance imaging (fMRI) will be used to measure activation of the DLPFC and associated neural circuits subserving emotion regulation and cognitive functioning (e.g., impulse control, episodic memory) in BPD.
Objective 1: To evaluate the efficacy of MST as a treatment for suicidal ideation and TRD in BPD.
Hypothesis 1: MST will demonstrate substantial efficacy on objective measures of suicidal ideation and depression.
Objective 2: To evaluate the effects of MST on cognitive functioning in patients with BPD.
Hypothesis 2: MST will have limited, if any, effects on performance on standard neuropsychological measures of attention, memory and executive functioning in patients with BPD.
Objective 3: To explore potential neuroimaging-based biomarkers that may index any changes in suicidal ideation and depression that result from treatment with MST.
Hypothesis 3: On neuroimaging tasks assessing emotion processing and cognitive functioning, patients receiving DBT+MST will show increased activity in bilateral DLPFC after treatment relative to pre-treatment baseline activation, and more activation in this region than patients in DBT without concurrent MST (DBT-only).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Using a case-control design, the investigators will compare individuals receiving MST and DBT with matched patient control group receiving DBT alone.
| Arm | Type | Receives |
|---|---|---|
| DBT Only | Other | Behavioral: DBTDialectical behavior therapy (DBT) is a specific type of cognitive-behavioral psychotherapy developed to help better treat borderline personality disorder. |
| MagPro MST with Cool TwinCoil + DBT | Experimental | Device: MagPro MST with Cool TwinCoil, Behavioral: DBTMST treatments will be administered using the MagPro MST with Cool TwinCoil. Moderate-to-highly suicidal patients with BPD beginning dialectical behavioural therapy (DBT) will be recruited using a case-control design, comparing individuals receiving MST and DBT with matched patient control group receiving DBT alone. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (22 listed)
- MST+DBT Group
- DBT-Only Group
Key exclusion criteria (33 listed)
- MST+DBT Group
- DBT-Only Group
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 MST with Cool TwinCoilAlso: Magnetic Seizure Therapy (MST)MST treatments will be administered using the MagPro MST with Cool TwinCoil. The investigators will evaluate the effectiveness of MST for reducing suicidality and depressive symptoms in an open-label clinical trial of up to 15 treatment sessions. Moderate-to-highly suicidal patients with BPD beginning dialectical behavioural therapy (DBT) will be recruited using a case-control design, comparing individuals receiving MST and DBT with matched patient control group receiving DBT alone. | Device | MagPro MST with Cool TwinCoil + DBT |
| DBTAlso: Dialectical behavior therapy (DBT)Dialectical behavior therapy (DBT) is a specific type of cognitive-behavioral psychotherapy developed to help better treat borderline personality disorder. Moderate-to-highly suicidal patients with BPD beginning dialectical behavioural therapy (DBT) will be recruited using a case-control design, comparing individuals receiving MST and DBT with matched patient control group receiving DBT alone. | Behavioural | DBT Only, MagPro MST with Cool TwinCoil + DBT |
Primary outcome
Improvement in symptom severity of depression as measured by the Hamilton Rating Scale for Depression - 24
Time frame: 5 weeks
Hamilton Rating Scale for Depression (24-item version) * 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)
Improvement in symptom severity of Suicidal Ideation as measured by the Modified Scale for Suicidal Ideation
Time frame: 5 weeks
Modified Scale for Suicidal Ideation * This scale is used to assess the presence or absence of suicidal ideation and the degree of severity of suicidal ideas * Scale range: 0-54 (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)
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 13 Feb 2025.
- Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addiction teaching hospitalLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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
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 MagPro MST with Cool TwinCoil and DBT in people with Borderline Personality Disorder, 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 22 inclusion and 33 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 13 Feb 2025. 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?
Improvement in symptom severity of depression as measured by the Hamilton Rating Scale for Depression - 24 (time frame: 5 weeks). The study lists 2 primary outcomes in all. 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 13 Feb 2025.