A Pilot Trial of One-Day Accelerated TMS and D-cycloserine in Suicidal Patients With Borderline Personality Disorder
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMclean Hospital
About this trial
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 questionnaires for 6 weeks after the treatment day.
Eligibility criteria
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- TMS
- D-Cycloserine (DCS)
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov