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A Pilot Trial of One-Day Accelerated TMS and D-cycloserine in Suicidal Patients With Borderline Personality Disorder

RecruitingPhase 1, Phase 2Ages 18 Years - anyAllMclean Hospital
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In plain words

What the trial is, and whether it could suit you

This study tests a new treatment for people with borderline personality disorder (BPD). The treatment combines a medication called D-cycloserine with one day of transcranial magnetic stimulation (TMS). The main questions it aims to answer are: * How many participants complete the treatment? * How do participants feel about the treatment? * Does the treatment have neurophysiological changes on participants? * Does the treatment improve BPD symptoms? * Do the benefits last over time? Participants will be asked to: * Come to the clinic for interviews and testing * Complete weekly questionnaires for 4 weeks before the treatment day * Take D-cycloserine the night before treatment * Attend one treatment day at the clinic. On that day, they may receive up to 20 short TMS sessions (each lasting 3 minutes and separated by 30 minutes). This visit may last up to 12 hours. * Complete weekly ques

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Adult (18+) of any gender * Meets DSM-5 criteria for BPD, per assessment with the Structured Clinic Interview for DSM-5 Personality Disorders (SCID-5-PD), BPD Module * Moderate to severe SI during the two weeks prior to screening, as indexed by a score of 9 or higher on the Modified Scale for Suicide Ideation - Self Report (Clum \& Yang, 1995) Exclusion Criteria: * Current manic or hypomanic symptoms, as assessed by the Diagnostic Assessment Research Tool (DART) screener and diagnostic modules, where relevant. * Current clinically significant psychotic symptoms not better accounted for by BPD, as assessed by the DART psychotic symptoms screener. * Current alcohol or substance use disorder, that in the opinion of a study PIs, is of sufficient severity to impede engagement in treatment or is associated with significant risk of medical withdrawal, as assessed by the DART. * Medical documentation or self-report of current anorexia nervosa, bulimia nervosa, or eating disorder not otherwise specified - atypical anorexia nervosa or atypical bulimia nervosa, that is in the opinion of a study PIs is of sufficient severity to be associated with significant medical risks * Acute suicide risk, sufficient to require immediate hospitalization; * history of traumatic brain injury (TBI) or concussion involving loss of consciousness or amnesia for โ‰ฅ24 hours; * any significant neurological disorder likely to be associated with increased intracranial pressure or cognitive impairment (e.g., epilepsy; Parkinson's disease); * diagnosed neurodevelopmental disorder (e.g., autism, downs syndrome; Ehlers-Danlos Syndrome) other than attention-deficit hyperactivity disorder (ADHD) or dyslexia * current diagnosis of delirium or dementia; * cognitive disorder secondary to a general medical condition * Pregnant and breastfeeding people are excluded in line with the studies our protocol is based upon using DCS and aTMS. Assessment of pregnancy will be completed during the 1-week prior to the administration of DCS (i.e., taken the night before TMS treatment), where relevant and according to MGB IRB policy. * Participants with contraindications to TMS (e.g., metal in head or neck area), or at increased risk for adverse events (e.g., seizure history or markedly heightened risk factors for seizures, serious medical problems, implanted devices) will be excluded. * Participants with a known allergy to DCS will be excluded from the study. * No patients with involuntary hospitalization status will be recruited for the study. * No individuals who are not proficient in English will be recruited for the study * Subject does not have a PCP
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What it tests

  • TMS
  • D-Cycloserine (DCS)
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Where

1 site
McLean Hospital
Belmont, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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