Treatment of Acute Mood Depressive Episode in Borderline Personality Disorder With rTMS


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Trial ID: NCT04870255


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).

Official Title

Modulating Probabilities: Prediction, Assessment, and Treatment of Acute Mood Depressive Episode in Borderline Personality Disorder With rTMS

Stanford Investigator(s)

David Spiegel
David Spiegel

Jack, Lulu and Sam Willson Professor of Medicine


Inclusion Criteria:

   - Male or Female, between the ages of 22 and 65 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

   - Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study

Exclusion Criteria:

   - Pregnancy

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

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

   - Current mania or psychosis

   - Bipolar I Disorder and primary psychotic disorders.

   - Autism Spectrum disorder or Intellectual Disability

   - A diagnosis of obsessive-compulsive disorder (OCD)

   - Current moderate or severe substance use disorder or demonstrating signs of acute
   substance withdrawal.

   - Urine screening test positive for illicit substances.

   - Any history of ECT (greater than 8 sessions) without meeting responder criteria

   - Recent (during the current depressive episode) or concurrent use of a rapid acting
   antidepressant agent (i.e., ketamine or a course of ECT).

   - History of significant neurologic disease, including dementia, Parkinson's or
   Huntington's disease, brain tumor, unexpected seizure/epilepsy disorder, subdural
   hematoma, multiple sclerosis, or history of significant head trauma.

   - Untreated or insufficiently treated endocrine disorder.

   - Contraindications to receiving rTMS (e.g., metal in head, history of seizure, known
   brain lesion)

   - Contraindications to MRI (ferromagnetic metal in their body).

   - Any current or past history of any physical condition which in the investigator's
   opinion might put the subject at risk or interfere with study results interpretation.

   - Depth-adjusted aiTBS treatment dose > 65% maximum stimulator output (MSO)

   - Treatment with another investigational drug or other intervention within the study

   - Any other condition deemed by the PI to interfere with the study or increase risk to
   the participant.


device: Left Dorsolateral Prefrontal Cortex (L-DLPFC)

device: Dorsomedial Prefrontal Cortex (DMPFC)

device: Sham Stimulation


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Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Jean-Marie Batail, MD, PhD