Magnetic Seizure Therapy for the Treatment of Borderline Personality Disorder

NCT03361826 | Completed

• 1 other identifier: 053/2015
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

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; Neuroimaging-based biomarkers

Outcome Measures

Primary Outcomes (2)

• 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)

  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)

  5 weeks

Study Arms (2)

DBT Only

OTHER

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

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.

Device: MagPro MST with Cool TwinCoil; Behavioral: DBT

Interventions

MagPro MST with Cool TwinCoil DEVICE

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.

Also known as: Magnetic Seizure Therapy (MST)

MagPro MST with Cool TwinCoil + DBT

DBT BEHAVIORAL

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.

Also known as: Dialectical behavior therapy (DBT)

DBT Only; MagPro MST with Cool TwinCoil + DBT

Eligibility Criteria

• Age: 18 Years - 50 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M5T 1R8, Canada

Location

Related Links

• Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addiction teaching hospital

MeSH Terms

Conditions

Borderline Personality Disorder; Suicidal Ideation; Depressive Disorder, Treatment-Resistant; Myeloproliferative Syndrome, Transient; Maple syrup urine disease, type 2

Interventions

Dialectical Behavior Therapy

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders; Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Daniel Blumberger, MD

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair, Temerty Centre for Therapeutic Brain Intervention

Model Details: Using a case-control design, the investigators will compare individuals receiving MST and DBT with matched patient control group receiving DBT alone.

Study Record Dates

• First Submitted: October 31, 2017
• First Posted: December 5, 2017
• Study Start: October 17, 2017
• Primary Completion: June 24, 2020
• Study Completion: June 24, 2020
• Last Updated: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)