Treatment of Acute Mood Depressive Episode in Borderline Personality Disorder With rTMS
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorStanford University
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
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
Treatments tested in this trial
- Left Dorsolateral Prefrontal Cortex (L-DLPFC)
- Dorsomedial Prefrontal Cortex (DMPFC)
- Sham Stimulation
Treatment groups
45 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov