Treatment of Acute Mood Depressive Episode in Borderline Personality Disorder With rTMS (NCT04870255) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Treatment of Acute Mood Depressive Episode in Borderline Personality Disorder With rTMS
United States45 participantsStarted 2021-07-20
Plain-language summary
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).
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion Criteria:
* 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).
* TMS naive.
* Access to ongoing psychiatric care before and after completion of the study.
* Access to clinical rTMS after study completion.
* In good general health, as evidenced by medical history.
* For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation.
* Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study duration.
Exclusion Criteria:
* Pregnancy
* The presence or diagnosis of prominent anxiety disorder, personality disorder, or d…
What they're measuring
1
Change in the clinician rated Montgomery-Asberg Depression Rating Scale (MADRS-C) in active L-DLPFC vs. sham aiTBS.
Timeframe: At baseline (pre-intervention), during the intervention and immediately after the intervention.