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

16. September 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

18

Phase

  • Phase 1

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

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

Studieren Sie die Kontaktsicherung

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

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

25 Jahre bis 65 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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.

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.

Andere Namen:
  • 4-Phosphoryloxy-N,N-dimethyltryptamin

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.

Andere Namen:
  • DBT + PAT

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Incidence, Severity, and Frequency of Adverse Events
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Zanarini Rating Scale Score
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Mitarbeiter

Ermittler

  • Hauptermittler: Ziad Nahas, MD, MSCR, University of Minnesota
  • Studienleiter: Devin H Hanson, PhD, LP, University of Minnesota

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Dezember 2026

Primärer Abschluss (Geschätzt)

31. Dezember 2029

Studienabschluss (Geschätzt)

31. Dezember 2030

Studienanmeldedaten

Zuerst eingereicht

10. September 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

16. September 2026

Zuerst gepostet (Tatsächlich)

22. September 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

22. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

16. September 2026

Zuletzt verifiziert

1. September 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • PSYCH-2026-35016
  • STUDY00029130 (Andere Kennung: University Of Minnesota- IRB)

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .