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Including Patients with Borderline Personality Disorder in Clinical Trials

By: Christine Moore, PhD, Vice President, Neuroscience, Scientific Solutions

Patients with borderline personality disorder (BPD) face a heightened risk of substance abuse and suicide, as well as substantial delays in receiving treatment. Despite these risks, there are no medications specifically approved to target the core symptoms of BPD; current treatments are limited to managing underlying affective symptoms. Over the past two decades, industry-sponsored clinical trials have targeted treatments for BPD, yielding some promising outcomes; however, broader psychiatric research often excludes BPD patients, a trend that extends to the emerging field of psychedelic studies.

Given the unmet need in this population, entry criteria for psychiatric trials are being re-visited to potentially allow those with BPD to enroll in psychiatric clinical trials. Specifically in psychedelic trials, the inclusion of patients with BPD is not only being reconsidered, but BPD may be of interest as a targeted indication.

By leveraging methodologies established in prior BPD trials, insights from psychedelic research in other conditions, and an understanding of the distinct challenges faced by individuals with BPD, we can outline possible trial methodology for a psychedelic in treating symptoms of BPD.

Challenges for the Inclusion of BPD Patients in a Psychedelic Trial

Apart from the difficulty in establishing a diagnosis, individuals with BPD often have difficulty forming connections with healthcare providers, an element that is essential for the success of psychedelic-assisted therapy. Moreover, the altered states of consciousness induced by psychedelics may exacerbate feelings of victimization — which is common among those with BPD. The intense nature of psychedelic experiences demands a level of emotional regulation that can be particularly taxing for individuals with BPD. Ensuring patient safety is a primary concern, necessitating increased vigilance for any escalation of symptoms or emergence of suicidality. These considerations, combined with the additional burden placed on clinical trial staff in the management of BPD patients, have historically led to the exclusion of this population from psychedelic trials.

Integrating BPD Patients into Psychedelic Research Trials

Exploring the therapeutic potential of psychedelics for BPD necessitates meticulous planning that encompasses both research design and operational logistics. Careful consideration must be given to several key aspects:

  • Ensuring proper identification of patients with BPD, which is often misdiagnosed
  • Determining the appropriate treatment approach, whether psychedelic-assisted psychotherapy or a supportive or facilitative model
  • Identifying and focusing on the specific symptoms of BPD to be addressed, and selecting outcome measures that are sensitive to changes in those areas
  • Distinguishing between symptomatic improvements in BPD and shifts in commonly associated comorbid conditions
  • Setting realistic expectations for both patients and clinical trial sites regarding the potential benefits of the treatment
  • Choosing sites with a profile that includes clinicians who have significant expertise in treating BPD patients
  • Successfully recruiting a patient cohort that typically might not seek BPD-specific treatment and ensuring their continued participation throughout the study
  • Providing specialized training to facilitators and session monitors to effectively support participants with BPD, which includes establishing boundaries and managing anxiety that may arise from challenging dosing experiences or negative affect afterwards.
  • Tailoring the focus of preparatory sessions preceding dosing and the integration sessions that follow
  • Developing a comprehensive plan for post-study care to ensure ongoing support for participants after the conclusion of the trial

Let’s Connect at the Psychedelics Therapeutics & Drug Development Conference

Join us for an in-depth discussion on the potential design and methodology of a clinical trial that includes patients with BPD at the Psychedelics Therapeutics & Drug Development Conference, taking place May 23-24, 2024, in Boston. I am looking forward to presenting on “Designing a Psychedelic Clinical Trial for Borderline Personality Disorder” at 11:15 AM on Thursday, May 23. This will be an excellent opportunity to delve into the specific considerations required when incorporating this distinct patient group into a psychedelic clinical trial.

To discuss your study with our team and see how we can support you, schedule time to meet with us onsite.