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

16. september 2026 opdateret af: University of Minnesota

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

18

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Ziad Nahas, MD, MSCR
  • Telefonnummer: 952-525-4505
  • E-mail: znahas@umn.edu

Undersøgelse Kontakt Backup

  • Navn: Rachel Johnson, MA, PhD
  • Telefonnummer: 952-525-4505
  • E-mail: ipl@umn.edu

Studiesteder

  • Forenede Stater
    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater, 55455
        • M Health Fairview DBT Program
        • Kontakt:
          • Ziad Nahas, MD, MSCR
          • Telefonnummer: 952-525-4505
          • E-mail: ipl@umn.edu
      • Saint Louis Park, Minnesota, Forenede Stater, 55416
        • M Physicians St. Louis Park Clinic
        • Kontakt:
          • Ziad Nahas, MD, MSCR
          • Telefonnummer: 952-525-4505
          • E-mail: ipl@umn.edu

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

25 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Medicin: 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.

Andre navne:
  • 4-phosphoryloxy-N,N-dimethyltryptamin
Adfærdsmæssigt: 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.

Andre navne:
  • DBT + PAT

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence, Severity, and Frequency of Adverse Events
Tidsramme: Baseline through final study visit at week 18

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
Tidsramme: Within 24 hours after each dosing visit

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
Tidsramme: Integration visit 24 hours after each dosing visit

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
Tidsramme: Integration visit 24 hours after each dosing visit

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
Tidsramme: Baseline through final study visit at week 18

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
Tidsramme: Baseline through final study visit at week 18

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
Tidsramme: Baseline through final study visit at week 18

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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Zanarini Rating Scale Score
Tidsramme: Baseline to final study visit at week 18

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
Tidsramme: Baseline to final study visit at week 18

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
Tidsramme: Baseline to final study visit at week 18

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
Tidsramme: Baseline to final study visit at week 18

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

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

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
Tidsramme: Baseline to final study visit at week 18

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
Tidsramme: Day before first dosing and day before second dosing

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
Tidsramme: Day before first dosing and day before second dosing

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
Tidsramme: Integration visit immediately after each dosing visit

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
Tidsramme: Through final study visit at week 18

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Minnesota

Samarbejdspartnere

Filament Health Corp.

Efterforskere

  • Ledende efterforsker: Ziad Nahas, MD, MSCR, University of Minnesota
  • Studieleder: Devin H Hanson, PhD, LP, University of Minnesota

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. december 2026

Primær færdiggørelse (Anslået)

31. december 2029

Studieafslutning (Anslået)

31. december 2030

Datoer for studieregistrering

Først indsendt

10. september 2026

Først indsendt, der opfyldte QC-kriterier

16. september 2026

Først opslået (Faktiske)

22. september 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • PSYCH-2026-35016
  • STUDY00029130 (Anden identifikator: University Of Minnesota- IRB)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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