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

Launched by STANFORD UNIVERSITY · Apr 28, 2021

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment approach for individuals experiencing a severe mood depressive episode linked to borderline personality disorder (BPD) or major depressive disorder (MDD). The treatment uses a technique called accelerated intermittent theta-burst stimulation (aiTBS), which is a type of brain stimulation aimed at improving mood and reducing depressive symptoms. The study is currently recruiting participants aged 22 to 65 who have been diagnosed with BPD and are experiencing a mood depressive episode.

To participate, individuals must be in good health and able to provide informed consent, meaning they understand the study and agree to take part. They should not have certain other mental health conditions, like severe anxiety or bipolar I disorder, and will need to be available for the duration of the study. Participants will receive aiTBS treatment and will be monitored closely throughout the trial. It's important for potential participants to know that they will continue to receive psychiatric care during and after the study, ensuring they have support throughout the process.

Gender

ALL

Eligibility criteria

• 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 dysthymia
• • Current severe insomnia (must sleep a minimum of 5 hours each night before stimulation)
• • 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 period.
• • Any other condition deemed by the PI to interfere with the study or increase risk to the participant.