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Dorsomedial rTMS For Depression In Borderline Personality Disorder (rTMS)

Primary Purpose

Borderline Personality Disorder, Major Depression

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Dorsomedial prefrontal rTMS
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Borderline Personality Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Are voluntary and competent to consent to treatment.
  • Have met DSM-5 diagnostic criteria for borderline personality disorder, AND
  • Have met DSM-5 diagnostic criteria of MDD single or recurrent, or Bipolar Disorder with a current Major Depressive Episode at the time of their consultation for rTMS.
  • Are females between the ages of 18 and 65
  • have failed to achieve a clinical response to an adequate dose of an antidepressant based on an Antidepressant Treatment History Form (ATHF) score of > 3 in the current episode OR have been unable to tolerate at least 2 separate trials of antidepressants of inadequate dose and duration (ATHF 1 or 2)
  • have a score ≥18 on the HRSD-17 item
  • able to adhere to the treatment schedule
  • pass the TMS safety-screening questionnaire
  • have normal thyroid functioning and no clinically significant abnormalities on CBC, on pre-study blood work.
  • are already under the care of a psychiatrist who agrees to provide continuity of all non-rTMS aspects of care throughout the study.

Exclusion Criteria:

  • Pregnancy
  • A lifetime Mini-International Neuropsychiatric Interview (MINI) diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, or current psychotic symptoms
  • A MINI diagnosis of obsessive compulsive disorder, post-traumatic stress disorder (current or within the last year), anxiety disorder (generalized anxiety disorder, social anxiety disorder, panic disorder), or dysthymia, assessed by a study investigator to be primary and causing greater impairment than current MDDcurrent MDD or BPD
  • Have received rTMS for any previous indication due to the potential compromise of subject blinding
  • 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, cerebral aneurysm, Parkinson's disease, Huntington's chorea, multiple sclerosis, significant head trauma with loss of consciousness for greater than or equal to 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
  • If participating in psychotherapy, must have been in stable treatment for at least 3 months prior to entry into the study, with no anticipation of change in the frequency of therapeutic sessions, or the therapeutic focus over the duration of the study
  • Medication: currently (or in the last 4 weeks) taking more than lorazepam 2 mg daily (or equivalent) or any dose of an anticonvulsant due to the potential to limit rTMS efficacy. Medication regimen should be stable for at least 4 weeks prior to first rTMS treatment.
  • Alcohol or substance use: severe substance use disorder (based on DSM-5 diagnostic criteria) assessed by the study investigator to be primary and causing greater impairment than MDD or BPD.
  • Non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview).
  • Serious suicide attempt that necessitate medical intervention during the last 3 months.

Sites / Locations

  • Toronto Western Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Active -> Sham

Sham -> Active

Arm Description

15 days of active, followed by 15 days of sham rTMS, targeting dorsomedial prefrontal cortex bilaterally, two sessions per day (1 hour apart), 20 Hz stimulation, at 120% resting motor threshold

15 days of sham, followed by 15 days of active rTMS, targeting dorsomedial prefrontal cortex bilaterally, two sessions per day (1 hour apart), 20 Hz stimulation, at 120% resting motor threshold

Outcomes

Primary Outcome Measures

HRSD-17 change
The change in the 17-item Hamilton Rating Scale for Depression from baseline to first followup (1 week post treatment) for period 1 and 2 of the treatment

Secondary Outcome Measures

ZAN-BPD change
The change in the Zanarini Rating Scale for Borderline Personality Disorder from baseline to first followup (1 week post treatment) for period 1 and 2 of the treatment

Full Information

First Posted
March 7, 2018
Last Updated
March 20, 2018
Sponsor
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT03472638
Brief Title
Dorsomedial rTMS For Depression In Borderline Personality Disorder
Acronym
rTMS
Official Title
Efficacy Of Repetitive Transcranial Magnetic Stimulation In The Treatment Of Refractory Depression Among Patients With Borderline Personality Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 2016 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
July 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Health Network, Toronto

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This randomized trial with a crossover design will examine the efficacy of rTMS targeting the dorsomedial prefrontal cortex as a treatment for medication-resistant major depression in patients meeting diagnostic criteria for borderline personality disorder.
Detailed Description
Patients meeting standard DSM-5 diagnostic criteria for borderline personality disorder, who also meet diagnostic criteria for a major depressive episode that has not responded to medication, will be eligible for inclusion. In a study with a randomized crossover design, they will undergo a course of either either active followed by sham or sham followed by active treatment. Each phase (active or sham) will involve 15 days of rTMS targeting the bilateral dorsomedial prefrontal cortex, 5x weekly, twice-daily with sessions 1 hour apart, using 20 Hz stimulation. Followup visits will occur at 1, 4, and 12 weeks after both courses of treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Borderline Personality Disorder, Major Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active -> Sham
Arm Type
Experimental
Arm Description
15 days of active, followed by 15 days of sham rTMS, targeting dorsomedial prefrontal cortex bilaterally, two sessions per day (1 hour apart), 20 Hz stimulation, at 120% resting motor threshold
Arm Title
Sham -> Active
Arm Type
Experimental
Arm Description
15 days of sham, followed by 15 days of active rTMS, targeting dorsomedial prefrontal cortex bilaterally, two sessions per day (1 hour apart), 20 Hz stimulation, at 120% resting motor threshold
Intervention Type
Device
Intervention Name(s)
Dorsomedial prefrontal rTMS
Other Intervention Name(s)
DMPFC-rTMS
Intervention Description
Active or sham rTMS targeting the dorsomedial prefrontal cortex, 20 Hz stimulation, 120% resting motor threshold, 1500 pulses per hemisphere, using a MagVenture R30 stimulator and Cool-DB80 coil.
Primary Outcome Measure Information:
Title
HRSD-17 change
Description
The change in the 17-item Hamilton Rating Scale for Depression from baseline to first followup (1 week post treatment) for period 1 and 2 of the treatment
Time Frame
baseline to first followup (1 week post treatment), 3 months post-treatment
Secondary Outcome Measure Information:
Title
ZAN-BPD change
Description
The change in the Zanarini Rating Scale for Borderline Personality Disorder from baseline to first followup (1 week post treatment) for period 1 and 2 of the treatment
Time Frame
baseline to first followup (1 week post treatment), 3 months post-treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Are voluntary and competent to consent to treatment. Have met DSM-5 diagnostic criteria for borderline personality disorder, AND Have met DSM-5 diagnostic criteria of MDD single or recurrent, or Bipolar Disorder with a current Major Depressive Episode at the time of their consultation for rTMS. Are females between the ages of 18 and 65 have failed to achieve a clinical response to an adequate dose of an antidepressant based on an Antidepressant Treatment History Form (ATHF) score of > 3 in the current episode OR have been unable to tolerate at least 2 separate trials of antidepressants of inadequate dose and duration (ATHF 1 or 2) have a score ≥18 on the HRSD-17 item able to adhere to the treatment schedule pass the TMS safety-screening questionnaire have normal thyroid functioning and no clinically significant abnormalities on CBC, on pre-study blood work. are already under the care of a psychiatrist who agrees to provide continuity of all non-rTMS aspects of care throughout the study. Exclusion Criteria: Pregnancy A lifetime Mini-International Neuropsychiatric Interview (MINI) diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, or current psychotic symptoms A MINI diagnosis of obsessive compulsive disorder, post-traumatic stress disorder (current or within the last year), anxiety disorder (generalized anxiety disorder, social anxiety disorder, panic disorder), or dysthymia, assessed by a study investigator to be primary and causing greater impairment than current MDDcurrent MDD or BPD Have received rTMS for any previous indication due to the potential compromise of subject blinding 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, cerebral aneurysm, Parkinson's disease, Huntington's chorea, multiple sclerosis, significant head trauma with loss of consciousness for greater than or equal to 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 If participating in psychotherapy, must have been in stable treatment for at least 3 months prior to entry into the study, with no anticipation of change in the frequency of therapeutic sessions, or the therapeutic focus over the duration of the study Medication: currently (or in the last 4 weeks) taking more than lorazepam 2 mg daily (or equivalent) or any dose of an anticonvulsant due to the potential to limit rTMS efficacy. Medication regimen should be stable for at least 4 weeks prior to first rTMS treatment. Alcohol or substance use: severe substance use disorder (based on DSM-5 diagnostic criteria) assessed by the study investigator to be primary and causing greater impairment than MDD or BPD. Non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview). Serious suicide attempt that necessitate medical intervention during the last 3 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Jonathan Downar, MD PhD
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toronto Western Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T2S8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Dorsomedial rTMS For Depression In Borderline Personality Disorder

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