Brain zaps for BPD depression: new hope or hype?
NCT ID NCT04870255
First seen Jun 27, 2026 · Last updated Aug 12, 2026 · Updated 2 times
Summary
This study tests a quick, non-invasive brain stimulation method called accelerated intermittent theta-burst stimulation (aiTBS) to see if it can improve mood in people with borderline personality disorder (BPD) who are also experiencing a major depressive episode. About 45 adults will receive either real or fake (sham) stimulation to compare effects. The goal is to measure changes in depression severity using a standard rating scale.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 45 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2021
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Stanford Hospital
RECRUITINGStanford, California, 94305, United States
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