About this trial

This study evaluates the antidepressant effects of an accelerated schedule of theta-burst stimulation, termed accelerated intermittent theta-burst stimulation (aiTBS), in individuals with borderline personality disorder (BPD) or trait and comorbid mood depressive disorder (MDD) or bipolar II disorder in a current mood depressive episode (MDE).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or Female, between the ages of 18 and 80 at the time of screening.

Able to read, understand, and provide written, dated informed consent prior to screening. Proficiency in English sufficient to complete questionnaires / follow instructions during fMRI assessments and aiTBS interventions. Stated willingness to comply with all study procedures, including availability for the duration of the study, and to communicate with study personnel about adverse events and other clinically important information.

Diagnosed with Major Depressive Disorder (MDD) or Bipolar II, or unspecified depressive disorder AND Borderline Personality Disorder or trait, with a current Mood Depressive Episode (MDE), according to the criteria defined in the Diagnosis and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5).

MADRS score of ≥20 at screening (Visit 1).

Disqualifiers

Pregnancy

The presence or diagnosis of prominent anxiety disorder, personality disorder, or dysthymia

Current severe insomnia (must sleep a minimum of 5 hours each night before stimulation)

Current mania or psychosis

Trial design

Design model

Parallel

Treatments tested in this trial

Left Dorsolateral Prefrontal Cortex (L-DLPFC)
Device
Participants who are randomly assigned to this group will receive active iTBS (intermittent theta burst stimulation) to the left DLPFC. Stimulation intensity will be standardized at 90% of resting motor threshold (adjusted for cortical depth). Stimulation will be delivered using the Magventure Magpro X100 TMS system.
Dorsomedial Prefrontal Cortex (DMPFC)
Device
Participants who are randomly assigned to this group will receive active iTBS (intermittent theta burst stimulation) to the DMPFC. Stimulation intensity will be standardized at 100% of resting motor threshold (adjusted for cortical depth). Stimulation will be delivered using the Magventure Magpro X100 TMS system.
Sham Stimulation
Device
Participants who are randomly assigned to this group will receive sham stimulation to the left DLPFC. Sham stimulation will be delivered using the Magventure Magpro X100 TMS system.

Treatment groups

45 Participants

are divided into 3 treatment groups

Group A: Left Dorsolateral Prefrontal Cortex (L-DLPFC)Active comparator 1 intervention

Group B: Dorsomedial Prefrontal Cortex (DMPFC)Active comparator 1 intervention

Group C: Sham stimulationSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in the clinician rated Montgomery-Asberg Depression Rating Scale (MADRS-C) in active L-DLPFC vs. sham aiTBS.

A ten item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders.The MADRS-C has an overall score range from 0-60, with higher scores corresponding to higher levels of depression.

Time frame