Treatment of Acute Mood Depressive Episode in Borderline Personality Disorder With rTMS
Modulating Probabilities: Prediction, Assessment, and Treatment of Acute Mood Depressive Episode in Borderline Personality Disorder With rTMS
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 80 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether a faster schedule of magnetic brain stimulation, called aiTBS, can ease depression. It is for adults who currently have depression and also have borderline personality disorder or traits of it.
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).
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be 18 to 80 years old and in good general health.
- Have major depression, bipolar II disorder, or an unspecified depression disorder, plus borderline personality disorder or traits of it. You must currently have a period of depression.
- Score at least 20 on the MADRS, a scale that measures depression symptoms.
- Have never received TMS, a treatment that uses magnets to stimulate the brain.
- Be able to read and understand the consent form and sign it before screening. Know enough English to answer questions and follow study instructions.
- Agree to attend study visits, follow study and lifestyle rules, and report side effects or other important health changes.
- Have access to ongoing mental health care before and after the study, and to rTMS treatment after the study.
- If you can become pregnant, use highly effective birth control for at least 1 month before screening and throughout the study.
Who can't join
- Be pregnant, or have severe trouble sleeping. You must sleep at least 5 hours each night before treatment.
- Have current mania (an unusually high or irritable mood), psychosis (trouble knowing what is real), bipolar I disorder, or a primary psychotic disorder.
- Have autism, an intellectual disability, or obsessive-compulsive disorder. The listing also excludes prominent anxiety disorders, personality disorders, or dysthymia (long-lasting depression).
- Have a current moderate or severe substance use disorder, signs of sudden withdrawal, or a urine test showing illegal drugs.
- Have had more than 8 ECT sessions without enough improvement. ECT uses electricity to treat depression. Recent use during this depression episode, or current use, of fast-acting treatments such as ketamine or ECT also excludes you.
- Have a serious brain or nerve disease, a major head injury, a hormone disorder that is not well treated, or another health condition the study doctor considers unsafe or likely to affect results.
- Have a reason magnetic brain treatment or MRI scans are unsafe, such as certain metal implants, seizures, or brain damage; or need an aiTBS dose above 65% of the device’s maximum output after adjustment for brain depth.
- Receive another experimental drug or treatment during the study, or have another condition the lead study doctor believes could interfere with the study or increase your risk.
Simplified for readability. The official criteria below are what the study team uses.
Official 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.
Study sites (1)
CA
- Stanford Hospital · Stanford, CA 94305Nick Bassano, MSW1 · Study contact · 6504347844 · nbassano@stanford.eduKatina Marchione · Study contact · kfmarch@stanford.eduDavid Spiegel, MD · Principal investigatorMore trials in Stanford