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Status unknownNCT03472638rTMSUpdated Mar 21, 2018

Dorsomedial rTMS For Depression In Borderline Personality Disorder

An interventional study of Dorsomedial prefrontal rTMS in Borderline Personality Disorder and Major Depression, sponsored by University Health Network, Toronto. Status unknown at 1 site in Canada. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-03-21.

Sponsored by University Health Network, Toronto · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2018), so the status shown — last known as Active, not recruiting — may be out of date.

From the registry’s dates

  • Registered 1 year 8 months after the study started (first participant enrolled Jul 2016, registered Mar 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 24 studies in Borderline Personality Disorder with a site in Canada — 7 open to participants now, 8 under way, none of them phase 3. Borderline Personality Disorder · Canada.

Enrollment
20th of 23
20 · median 60
Started
2016
with 1 other
No phase
19 of 24
4 open now
Registered
10th of 24
by date
Lead sponsor
1 of 24
University Health Network, Toronto

Among the 24 studies in Borderline Personality Disorder with a site in Canada, this one is the 20th largest by enrollment of the 23 interventional ones that give a count, is one of 2 that started in 2016, is one of 19 with no phase, and was the 10th registered.

Borderline Personality Disorder

278 studies on the registry are indexed under Borderline Personality Disorder; 70 are open to participants now.

Browse Borderline Personality Disorder studies →

Open to participants now

7 of the 24 studies in Borderline Personality Disorder with a site in Canada are open now. Recruiting first, the newest first:

2 more — sign in →

All 7 open studies →

A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →

Who these studies take

Of the 49 Borderline Personality Disorder studies recruiting now, 18 (37%) set no upper age limit and 30 (61%) stop at 75 or younger; 8 take children under 18; 11 take healthy volunteers.

This study: 18 Years to 65 Years · female · no healthy volunteers.

The full table on the hub →

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02

Study 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.

Read the 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.

03

Conditions studied

  • Borderline Personality Disorder
  • Major Depression
04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Are voluntary and competent to consent to treatment.
  • Have met 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 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

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 diagnostic criteria) assessed by the study investigator to be primary and causing greater impairment than MDD or BPD.
  • Non-correctable sensory impairment (i.e., cannot hear well enough to cooperate with interview).
  • Serious suicide attempt that necessitate medical intervention during the last 3 months.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
20 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • DeviceDorsomedial 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.

    Also known as: DMPFC-rTMS

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: baseline to first followup (1 week post treatment), 3 months post-treatment

Secondary outcomes

  1. 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

    Time frame: baseline to first followup (1 week post treatment), 3 months post-treatment

07

Study locations

1 site
  • Toronto Western Hospital
    Toronto, Ontario M5T2S8, Canada
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2016 to primary completion in Dec 2017, 17 months.

Of 105 non-industry interventional studies with no phase under Borderline Personality Disorder, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 54. This study's 17 months is below that.

Counting every sponsor, half of 107 studies reached it within 35 months; a quarter within 24 and three quarters within 54.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 7, 2018
First posted
Mar 21, 2018
StartActual
Jul 2016
Primary completionActual
Dec 2017
CompletionEst.
Jul 2018
Last update
Mar 21, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 21, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03472638
Lead sponsor
University Health Network, Toronto
Responsible party
Jonathan Downar (Director, MRI-Guided rTMS Clinic, University Health Network, University Health Network, Toronto) — Principal investigator
First posted
Mar 21, 2018
Start date
Jul 2016
Primary completion
Dec 2017
Completion
Jul 2018 (estimated)
Last update
Mar 21, 2018

Study contacts

Dr. Jonathan Downar, MD PhD
principal investigator · University Health Network, Toronto

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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