Treatment of Acute Mood Depressive Episode in Borderline Personality Disorder with RTMS

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 toscreening. Proficiency in English sufficient to complete questionnaires / followinstructions during fMRI assessments and aiTBS interventions. Stated willingness tocomply with all study procedures, including availability for the duration of thestudy, and to communicate with study personnel about adverse events and otherclinically important information.

• Diagnosed with Major Depressive Disorder (MDD) or Bipolar II, or unspecifieddepressive disorder AND Borderline Personality Disorder or trait, with a currentMood Depressive Episode (MDE), according to the criteria defined in the Diagnosisand 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 atleast 1 month prior to screening and agreement to use such a method during studyparticipation.

• Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout studyduration.

Exclusion Criteria:

• Pregnancy

• The presence or diagnosis of prominent anxiety disorder, personality disorder, ordysthymia

• Current severe insomnia (must sleep a minimum of 5 hours each night beforestimulation)

• 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 acutesubstance 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 actingantidepressant agent (i.e., ketamine or a course of ECT).

• History of significant neurologic disease, including dementia, Parkinson's orHuntington's disease, brain tumor, unexpected seizure/epilepsy disorder, subduralhematoma, 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, knownbrain lesion)

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

• Any current or past history of any physical condition which in the investigator'sopinion might put the subject at risk or interfere with study resultsinterpretation.

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

• Treatment with another investigational drug or other intervention within the studyperiod.

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