Status:
COMPLETED
Magnetic Seizure Therapy for the Treatment of Borderline Personality Disorder
Lead Sponsor:
Centre for Addiction and Mental Health
Conditions:
Borderline Personality Disorder
Eligibility:
FEMALE
18-50 years
Phase:
NA
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...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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 ≥ 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
Key Trial Info
Start Date :
October 17 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 24 2020
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT03361826
Start Date
October 17 2017
End Date
June 24 2020
Last Update
February 13 2025
Active Locations (1)
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1
Centre for Addiction and Mental Health
Toronto, Ontario, Canada, M5T 1R8