Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Dorsomedial rTMS For Depression In Borderline Personality Disorder (rTMS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03472638
Recruitment Status : Active, not recruiting
First Posted : March 21, 2018
Last Update Posted : March 21, 2018
Sponsor:
Information provided by (Responsible Party):
Jonathan Downar, University Health Network, Toronto

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.

Condition or disease Intervention/treatment Phase
Borderline Personality Disorder Major Depression Device: Dorsomedial prefrontal rTMS Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy Of Repetitive Transcranial Magnetic Stimulation In The Treatment Of Refractory Depression Among Patients With Borderline Personality Disorder
Actual Study Start Date : July 2016
Actual Primary Completion Date : December 2017
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Active -> Sham
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
Device: Dorsomedial prefrontal rTMS
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.
Other Name: DMPFC-rTMS

Experimental: Sham -> Active
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
Device: Dorsomedial prefrontal rTMS
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.
Other Name: DMPFC-rTMS




Primary Outcome Measures :
  1. HRSD-17 change [ Time Frame: baseline to first followup (1 week post treatment), 3 months post-treatment ]
    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 :
  1. ZAN-BPD change [ Time Frame: baseline to first followup (1 week post treatment), 3 months post-treatment ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03472638


Locations
Layout table for location information
Canada, Ontario
Toronto Western Hospital
Toronto, Ontario, Canada, M5T2S8
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Layout table for investigator information
Principal Investigator: Dr. Jonathan Downar, MD PhD University Health Network, Toronto

Layout table for additonal information
Responsible Party: Jonathan Downar, Director, MRI-Guided rTMS Clinic, University Health Network, University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT03472638     History of Changes
Other Study ID Numbers: 15-9928
First Posted: March 21, 2018    Key Record Dates
Last Update Posted: March 21, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Layout table for MeSH terms
Disease
Depression
Depressive Disorder
Depressive Disorder, Major
Personality Disorders
Borderline Personality Disorder
Pathologic Processes
Behavioral Symptoms
Mood Disorders
Mental Disorders