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Magnetic Seizure Therapy for the Treatment of Borderline Personality Disorder

Primary Purpose

Borderline Personality Disorder

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
MagPro MST with Cool TwinCoil
DBT
Sponsored by
Centre for Addiction and Mental Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Borderline Personality Disorder focused on measuring 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

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • MST+DBT Group

    1. English-speaking and able to provide informed consent to participate in the study
    2. Female and between the ages 18 and 50 years
    3. 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)
    4. 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)
    5. 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
    6. Hamilton Rating Scale for Depression (HRSD-24) score > 22 (classified as Very Severe Depression)
    7. 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)
    8. Deemed appropriate to receive ECT as assessed by an ECT attending psychiatrist and an anesthesiologist
    9. Meets the MST safety criteria
    10. Agreeable to keeping their current antidepressant treatment (if any) constant during the intervention (unless clinically indicated)
    11. Has a close family member, friend, partner, or qualified chaperone able and willing to accompany the patient home after each MST treatment session and
    12. Able to adhere to the intervention schedule.
  • DBT-Only Group

    1. English-speaking and able to provide informed consent to participate in the study
    2. Female and between the ages 18 and 50 years
    3. Current DSM-IV diagnosis of BPD based on the International Personality Disorder Examination BPD Section (IPDE-BPD)
    4. 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)
    5. 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
    6. Baseline Hamilton Rating Scale for Depression (HRSD-24) score > 22
    7. 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)
    8. Agreeable to keeping their current antidepressant treatment (if any) constant during the study (unless clinically indicated)

Exclusion Criteria:

  • MST+DBT Group

    1. Acute suicidal intent that requires hospitalization to protect harm to self
    2. Any unstable medical and/or neurological condition
    3. Currently pregnant or lactating, or intention to get pregnant during the duration of the study
    4. Not considered sufficiently physically healthy to undergo general anesthesia for any reason
    5. 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)
    6. 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)
    7. Current diagnosis of delirium, dementia or another cognitive disorder secondary to a general medical condition
    8. Diagnosis of a developmental disorder (e.g. Down syndrome, autism-spectrum disorder)
    9. Non-correctable clinically significant sensory impairment (i.e., cannot hear or see well enough to complete the neuropsychological tests)
    10. Lower than eighth-grade reading level as assessed by the Wide Range Achievement Test-Fourth Edition
    11. Alcohol or substance use disorder (relating to opioids or cocaine) currently or within the past 1 month
    12. Diagnosis of a DSM-5 psychotic disorder
    13. Demonstrated a lack of response to ECT during the current or prior depressive episode.
    14. 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
    15. 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
    16. Has sustained a moderate-to-severe head injury (defined as โ‰ฅ 20 min loss of consciousness and/or > 24 hrs post-traumatic amnesia); or
    17. Does not qualify for MRI scanning
  • DBT-Only Group

    1. Acute suicidal intent that requires hospitalization to protect harm to self
    2. Any unstable medical and/or neurological condition
    3. Currently pregnant or lactating, or intention to get pregnant during the duration of the study
    4. 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)
    5. 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)
    6. Current diagnosis of delirium, dementia or another cognitive disorder secondary to a general medical condition
    7. Diagnosis of a developmental disorder (e.g. Down syndrome, autism-spectrum disorder)
    8. Non-correctable clinically significant sensory impairment (i.e., cannot hear or see well enough to complete the neuropsychological tests)
    9. Lower than eighth-grade reading level as assessed by the Wide Range Achievement Test--Fourth Edition
    10. Alcohol or substance use disorder (relating to opioids or cocaine use) currently or within the past 1 month
    11. Diagnosis of a DSM-5 psychotic disorder
    12. 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
    13. Has sustained a moderate-to-severe head injury (defined as โ‰ฅ 20 min loss of consciousness and/or > 24 hrs post-traumatic amnesia)
    14. Does not qualify for MRI scanning

Sites / Locations

  • Centre for Addiction and Mental Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

DBT Only

MagPro MST with Cool TwinCoil + DBT

Arm Description

Dialectical behavior therapy (DBT) is a specific type of cognitive-behavioral psychotherapy developed to help better treat borderline personality disorder.

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.

Outcomes

Primary Outcome Measures

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)
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)

Secondary Outcome Measures

Full Information

First Posted
October 31, 2017
Last Updated
November 11, 2022
Sponsor
Centre for Addiction and Mental Health
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1. Study Identification

Unique Protocol Identification Number
NCT03361826
Brief Title
Magnetic Seizure Therapy for the Treatment of Borderline Personality Disorder
Official Title
Magnetic Seizure Therapy for the Treatment of Treatment-Resistant Depression and Suicidal Ideation in Borderline Personality Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
October 17, 2017 (Actual)
Primary Completion Date
June 24, 2020 (Actual)
Study Completion Date
June 24, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre for Addiction and Mental Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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, Neuroimaging-based biomarkers

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Non-Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DBT Only
Arm Type
Other
Arm Description
Dialectical behavior therapy (DBT) is a specific type of cognitive-behavioral psychotherapy developed to help better treat borderline personality disorder.
Arm Title
MagPro MST with Cool TwinCoil + DBT
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
MagPro MST with Cool TwinCoil
Other Intervention Name(s)
Magnetic Seizure Therapy (MST)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
DBT
Other Intervention Name(s)
Dialectical behavior therapy (DBT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Improvement in symptom severity of depression as measured by the Hamilton Rating Scale for Depression - 24
Description
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)
Time Frame
5 weeks
Title
Improvement in symptom severity of Suicidal Ideation as measured by the Modified Scale for Suicidal Ideation
Description
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)
Time Frame
5 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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) Exclusion Criteria: 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) 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 โ‰ฅ 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 โ‰ฅ 20 min loss of consciousness and/or > 24 hrs post-traumatic amnesia) Does not qualify for MRI scanning
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Blumberger, MD
Organizational Affiliation
Centre for Addiction and Mental Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Addiction and Mental Health
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 1R8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.camh.net/research
Description
Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addiction teaching hospital

Learn more about this trial

Magnetic Seizure Therapy for the Treatment of Borderline Personality Disorder

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