ADEPT Psilocybin-Assisted Therapy With DBT for Borderline Personality Disorder (ADEPT)

ADEPT: Augmenting DBT Effectiveness With Psilocybin-Assisted Therapy

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Suicidal Ideation; Depressive Symptoms; Borderline Personality Disorder; Emotion Dysregulation; Borderline Personality Pathology
• Intervention / Treatment: Drug: Psilocybin; Behavioral: Psilocybin-Assisted Therapy With Dialectical Behavior Therapy

Detailed Description

ADEPT is an open-label proof-of-concept study designed to assess the safety and tolerability of combining psilocybin-assisted therapy with Dialectical Behavior Therapy in participants with borderline personality disorder.

The study will enroll up to 18 participants who have a confirmed DSM-5 diagnosis of borderline personality disorder and are enrolled in the M Health Fairview Dialectical Behavior Therapy program. Participants must have been enrolled in DBT for at least one month and must have consistent attendance in both group and individual therapy.

The study intervention includes two 25 mg doses of psilocybin administered during supervised dosing visits. Three preparation therapy visits will occur before the first dosing visit. The first dosing visit will be followed by three integration therapy visits. A second psilocybin dosing visit will occur approximately 21 days later, followed by three additional integration therapy visits. Participants will complete a final follow-up visit at week 18, approximately 12 weeks after the second dosing visit.

Participants will continue their usual DBT program while enrolled in the study. The M Health Fairview DBT program includes weekly individual therapy, group therapy skills development, and access to phone coaching.

The primary focus of the study is safety and tolerability. Participants will be monitored during and after dosing, and adverse events, treatment-emergent adverse events, serious adverse events, suicidal ideation, challenging experiences, and psychedelic-related side effects will be assessed. Secondary outcomes will evaluate changes in borderline personality disorder symptoms, emotion regulation, depressive symptoms, quality of life, treatment credibility and expectancy, mystical experience, and continued participation in DBT after psilocybin-assisted therapy.

• Study Type: Interventional
• Enrollment (Estimated): 18
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Ziad Nahas, MD, MSCR; Phone Number: 952-525-4505; Email: znahas@umn.edu
• Study Contact Backup: Name: Rachel Johnson, MA, PhD; Phone Number: 952-525-4505; Email: ipl@umn.edu

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • M Health Fairview DBT Program
      • Contact: Ziad Nahas, MD, MSCR; Phone Number: 952-525-4505; Email: ipl@umn.edu
    • Saint Louis Park, Minnesota, United States, 55416
      • M Physicians St. Louis Park Clinic
      • Contact: Ziad Nahas, MD, MSCR; Phone Number: 952-525-4505; Email: ipl@umn.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: DBT Plus Psilocybin-Assisted Therapy; 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; 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.; Other Names: 4-phosphoryloxy-N,N-dimethyltryptamine; Behavioral: Psilocybin-Assisted Therapy With Dialectical Behavior Therapy; 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.; Other Names: DBT + PAT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline to final study visit at week 18
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.	Baseline to final study visit at week 18
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	Baseline to final study visit at week 18
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	Baseline to final study visit at week 18
Change in Montgomery-Asberg Depression Rating Scale Score	Depressive symptoms will be assessed using the Montgomery-Asberg Depression Rating Scale and Quick Inventory of Depressive Symptomatology. Unit: Points	Baseline, week 8 after the second dose, and 3 months after the last drug dose or at DBT exit
Change in Quick Inventory of Depressive Symptomatology Score	Depressive symptoms will be assessed using the Quick Inventory of Depressive Symptomatology. Change in score will be assessed from baseline to week 8 after the second dose and 3 months after the last drug dose or at DBT exit. Higher scores indicate greater depressive symptom severity. Unit: Points	Baseline, week 8 after the second dose, and 3 months after the last drug dose or at DBT exit
Change in Quality of Life Enjoyment and Satisfaction Questionnaire Short Form Score	Quality of life will be assessed using the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form. Change in score will be assessed from baseline to the final study visit at week 18. Higher scores indicate greater quality of life enjoyment and satisfaction. Unit: points	Baseline to final study visit at week 18
Credibility and Expectancy Questionnaire Credibility Score	Treatment credibility will be assessed using the Credibility and Expectancy Questionnaire. Scores will be assessed the day before the first dosing visit and the day before the second dosing visit. Higher scores indicate greater treatment credibility. Unit: Points	Day before first dosing and day before second dosing
Credibility and Expectancy Questionnaire Expectancy Score	Treatment expectancy will be assessed using the Credibility and Expectancy Questionnaire. Scores will be assessed the day before the first dosing visit and the day before the second dosing visit. Higher scores indicate greater treatment expectancy. Unit: Points	Day before first dosing and day before second dosing
Mystical Experience After Psilocybin Dosing	Mystical experience after psilocybin dosing will be assessed using the Mystical Experience Questionnaire. Higher scores indicate greater intensity of mystical-type experience. Unit: Points	Integration visit immediately after each dosing visit
Rate of Continued Participation in Dialectical Behavior Therapy	Continued participation in Dialectical Behavior Therapy after psilocybin-assisted therapy will be assessed as the rate of DBT participation through the final study visit at week 18. Unit: percentage of scheduled DBT sessions attended	Through final study visit at week 18

Collaborators and Investigators

• Sponsor: University of Minnesota
• Collaborators: Filament Health Corp.
• Investigators: Principal Investigator: Ziad Nahas, MD, MSCR, University of Minnesota; Study Director: Devin H Hanson, PhD, LP, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: September 10, 2026
• First Submitted That Met QC Criteria: September 16, 2026
• First Posted (Actual): September 22, 2026

Study Record Updates

• Last Update Posted (Actual): September 22, 2026
• Last Update Submitted That Met QC Criteria: September 16, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: DBT; Psilocybin; Emotion dysregulation; Psilocybin-assisted therapy; DBT+PAT; ADEPT
• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Self-Injurious Behavior; Suicide; Personality Disorders; Behavior; Suicidal Ideation; Depression; Borderline Personality Disorder; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Alkaloids; Indoles; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Indole Alkaloids; Indolizidines; Indolizines; Tryptamines; Psilocybin; Dialectical Behavior Therapy
• Other Study ID Numbers: PSYCH-2026-35016; STUDY00029130 (Other Identifier: University Of Minnesota- IRB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No