One-Day Accelerated TMS with D-cycloserine in adults with borderline personality disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 1/2, interventional trial evaluating a combination of transcranial magnetic stimulation (TMS) delivered in a single extended treatment day and D-cycloserine for adults with borderline personality disorder and recent suicidal ideation. Participants complete questionnaires before and after the treatment day, receive D-cycloserine the night before, and may undergo up to 20 brief TMS sessions on the treatment day, with follow-up assessments for six weeks. The study aims to assess feasibility, safety, tolerability, participant perceptions, neurophysiological changes, symptom improvement, and durability of any effects. Primary outcomes focus on treatment completion and tolerability; secondary outcomes explore changes in BPD symptoms and suicidal ideation, with exploratory measures of neurophysiological response. The trial is conducted at McLean Hospital in Belmont, MA, led by McLean Hospital investigators.

Why it matters

Who can join: the full rules

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 ≥24 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

Where it's running

• McLean Hospital
  Belmont, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Jenna M Traynor, PhD — Mclean Hospital
• Study coordinator: Alexandra Velev, BA
• Email: avelev@mclean.harvard.edu
• Phone: 617-855-3430

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.