ADEPT Psilocybin-Assisted Therapy With DBT for Borderline Personality Disorder

NCT07833761 | Not Yet Recruiting Phase 1 FDA Drug

• 2 other identifiers: PSYCH-2026-35016STUDY00029130
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Borderline Personality Disorder; Borderline Personality Pathology; Depressive Symptoms; Emotion Dysregulation; Suicidal Ideation

Keywords

Psilocybin-assisted therapy; DBT; Psilocybin; DBT+PAT; ADEPT; Emotion dysregulation

Outcome Measures

Primary Outcomes (7)

• 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.

  Baseline through final study visit at week 18

• 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.

  Within 24 hours after each dosing visit

• Challenging Experiences After Psilocybin Dosing

  Challenging experiences after psilocybin dosing will be assessed using the Challenging Experiences Questionnaire.

  Integration visit 24 hours after each dosing visit

• Psilocybin-Related Side Effects

  Psilocybin-related side effects will be assessed using the Swiss Psychedelic Side Effects Inventory.

  Integration visit 24 hours after each dosing visit

• Percentage of Participants Who Complete the Study

  Study retention will be assessed as the percentage of enrolled participants who complete the final study visit at week 18. Unit: percentage of participants

  Baseline through final study visit at week 18

• Percentage of DBT Therapy Sessions Attended

  Dialectical Behavior Therapy session attendance will be assessed as the percentage of scheduled DBT therapy sessions attended during study participation. Unit: Percentage of sessions

  Baseline through final study visit at week 18

• Percentage of Study Assessments Completed

  Assessment completion will be assessed as the percentage of scheduled study assessments completed during study participation. Unit: percentage of assessments

  Baseline through final study visit at week 18

Secondary Outcomes (11)

• Change in Zanarini Rating Scale Score

  Baseline to final study visit at week 18

• Change in Personality Inventory for DSM-5 Score

  Baseline to final study visit at week 18

• Change in Difficulties in Emotion Regulation Scale-16 Score

  Baseline to final study visit at week 18

• Change in Inventory of Personality Organization Score

  Baseline to final study visit at week 18

• Change in Montgomery-Asberg Depression Rating Scale Score

  Baseline, week 8 after the second dose, and 3 months after the last drug dose or at DBT exit

Study Arms (1)

DBT Plus Psilocybin-Assisted Therapy

EXPERIMENTAL

Participants enrolled in the M Health Fairview Dialectical Behavior Therapy program will receive psilocybin-assisted therapy in addition to ongoing DBT. The study includes three preparation visits, two psilocybin dosing visits, integration visits after each dosing visit, and a final follow-up visit at week 18.

Drug: Psilocybin; Behavioral: Psilocybin-Assisted Therapy With Dialectical Behavior Therapy

Interventions

Psilocybin DRUG

Participants 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.

Also known as: 4-phosphoryloxy-N,N-dimethyltryptamine

DBT Plus Psilocybin-Assisted Therapy

Psilocybin-Assisted Therapy With Dialectical Behavior Therapy BEHAVIORAL

Participants 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.

Also known as: DBT + PAT

DBT Plus Psilocybin-Assisted Therapy

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead
• Filament Health Corp.: collaborator

Study Sites (2)

M Health Fairview DBT Program

Minneapolis, Minnesota, 55455, United States

Location

M Physicians St. Louis Park Clinic

Saint Louis Park, Minnesota, 55416, United States

Location

MeSH Terms

Conditions

Borderline Personality Disorder; Depression; Suicidal Ideation

Interventions

Psilocybin; Dialectical Behavior Therapy

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Suicide; Self-Injurious Behavior

Intervention Hierarchy (Ancestors)

Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tryptamines; Indolizidines; Indolizines; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Ziad Nahas, MD, MSCR

  University of Minnesota

  PRINCIPAL INVESTIGATOR

• Devin H Hanson, PhD, LP

  University of Minnesota

  STUDY DIRECTOR

Central Study Contacts

Ziad Nahas, MD, MSCR

CONTACT

952-525-4505; znahas@umn.edu

Rachel Johnson, MA, PhD

CONTACT

952-525-4505; ipl@umn.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is an open-label, single-group proof-of-concept study evaluating the safety and tolerability of psilocybin-assisted therapy in conjunction with ongoing Dialectical Behavior Therapy in participants with borderline personality disorder. Participants will receive preparation sessions, two psilocybin dosing sessions, integration sessions, and a final follow-up visit over approximately 18 weeks.

Study Record Dates

• First Submitted: September 10, 2026
• First Posted: September 22, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2030
• Last Updated: September 22, 2026

Record last verified: 2026-09

Locations

US (2)