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Not yet recruitingPhase 1

ADEPT Psilocybin-Assisted Therapy With DBT for Borderline Personality Disorder

NCT07833761 · ADEPT · University of Minnesota

Closed to entry
Status
Not accepting participants
Phase 1
Phase
18
Target enrolment
2
Study sites
1 US states

What it is testing

Summary

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Incidence, Severity, and Frequency of Adverse Events

    Measured over Baseline through final study visit at week 18

  • Acute Suicidal Ideation After Psilocybin Dosing

    Measured over Within 24 hours after each dosing visit

  • Challenging Experiences After Psilocybin Dosing

    Measured over Integration visit 24 hours after each dosing visit

  • Psilocybin-Related Side Effects

    Measured over Integration visit 24 hours after each dosing visit

  • Percentage of Participants Who Complete the Study

    Measured over Baseline through final study visit at week 18

  • Percentage of DBT Therapy Sessions Attended

    Measured over Baseline through final study visit at week 18

  • Percentage of Study Assessments Completed

    Measured over Baseline through final study visit at week 18

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

25 Years to 65 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: * 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 * Ability to complete all protocol-required assessment tools without assistance or alteration to copyrighted assessments * Ability to comply with all study visits * Stated willingness to comply with all study procedures and avoid changes to current treatments for the duration of the study * If of childbearing potential, use of an acceptable birth control method, including abstinence Exclusion Criteria: * 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 * History of suicide attempt in the last 6 months * Comorbid autism * Pregnant or may have reason to believe they are pregnant * Pre-existing valvular heart disease or pulmonary hypertension * Active primary PTSD diagnosis * Psychiatric or other condition judged to be incompatible with establishment of rapport or safe exposure to psilocybin * Any medical or psychiatric disorder, disease, condition, injury, symptom, or circumstance that may reduce ability to fulfill study requirements, adversely impact data integrity or validity, or pose increased risk during study participation * Children * Prisoners * Adults lacking capacity to consent or adults with diminished or fluctuating capacity to consent * Non-English speakers * Individuals unable to read * Employees of the researcher * Students of the researcher * Active members of the military or DoD personnel

Where

2 study sites

FacilityCityRegionCountry
M Health Fairview DBT ProgramMinneapolisMinnesotaUnited States
M Physicians St. Louis Park ClinicSaint Louis ParkMinnesotaUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT07833761 on ClinicalTrials.gov →

Last updated in the registry 2026-09-22. Registry records change; this page reflects the data build of 2026-09-24.

Related

Where this trial sits