ADEPT is an open-label proof-of-concept study evaluating the safety and tolerability of psilocybin-assisted therapy in conjunction with Dialectical Behavior Therapy for participants with borderline personality disorder.
Participants enrolled in the M Health Fairview Dialectical Behavior Therapy program will receive preparation therapy sessions, two supervised 25 mg psilocybin dosing sessions, integration therapy sessions, and a final follow-up visit. Participants will continue their usual DBT program during study participation.
The study will primarily assess safety and tolerability, including adverse events, treatment-emergent adverse events, serious adverse events, suicidal ideation, challenging psychedelic experiences, psilocybin-related side effects, study retention, therapy session attendance, and assessment completion.
Confirmed DSM-5 diagnosis of borderline personality disorder using clinical records and measures used in the M Health Fairview DBT program
Enrolled in the M Health Fairview DBT program for at least one month, with consistent attendance in group and individual therapy
Age 25 to 65 years
Able to speak and understand English
Refusal to give informed consent
History of bipolar affective disorder type I or II, schizophrenia, psychosis, delusions, paranoia, schizoaffective disorder, or substance use disorder within the past 12 months
First- or second-degree relative with schizophrenia or any other psychotic disorder
Active suicidal ideation with at least some intent and/or plan, defined as a current score of 4 or 5 on the C-SSRS
Single group
Psilocybin
DrugParticipants will receive two 25 mg doses of psilocybin during supervised dosing visits. Each dosing visit will include study therapist support for a minimum of 6 hours, with preparation and integration therapy sessions before and after dosing.
Psilocybin-Assisted Therapy With Dialectical Behavior Therapy
BehavioralParticipants will continue in the M Health Fairview Dialectical Behavior Therapy program while receiving psilocybin-assisted therapy. The study therapy sequence includes three preparation visits before the first dosing session, three integration visits after the first dosing session, a second dosing session, and three additional integration visits.
Incidence, Severity, and Frequency of Adverse Events
Safety and tolerability will be assessed by the incidence, severity, and frequency of adverse events, treatment-emergent adverse events, and serious adverse events during the study.
Acute Suicidal Ideation After Psilocybin Dosing
Acute suicidal ideation will be assessed after each psilocybin dosing visit using the Modified Scale for Suicidal Ideation and related safety assessments.
Challenging Experiences After Psilocybin Dosing
Challenging experiences after psilocybin dosing will be assessed using the Challenging Experiences Questionnaire.
Psilocybin-Related Side Effects
Psilocybin-related side effects will be assessed using the Swiss Psychedelic Side Effects Inventory.
Change in Zanarini Rating Scale Score
Borderline personality disorder symptoms will be assessed using the Zanarini Rating Scale. Change in score will be assessed from baseline to the final study visit at week 18. Higher scores indicate greater borderline personality disorder symptom severity. Unit: Points
Change in Personality Inventory for DSM-5 Score
Borderline personality disorder symptoms will be assessed using the Zanarini Rating Scale, Personality Inventory for DSM-5, Inventory of Personality Organization, and Difficulties in Emotion Regulation Scale-16.
Change in Difficulties in Emotion Regulation Scale-16 Score
Emotion regulation difficulties will be assessed using the Difficulties in Emotion Regulation Scale-16. Change in score will be assessed from baseline to the final study visit at week 18. Higher scores indicate greater emotion regulation difficulties. Unit: Points
Change in Inventory of Personality Organization Score
Personality organization will be assessed using the Inventory of Personality Organization. Change in score will be assessed from baseline to the final study visit at week 18. Higher scores indicate greater impairment in personality organization. Unit: Points
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University of Minnesota
Lead sponsor
Filament Health Corp.
Collaborator
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