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

16. září 2026 aktualizováno: 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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

18

Fáze

  • Fáze 1

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

  • Jméno: Ziad Nahas, MD, MSCR
  • Telefonní číslo: 952-525-4505
  • E-mail: znahas@umn.edu

Studijní záloha kontaktů

  • Jméno: Rachel Johnson, MA, PhD
  • Telefonní číslo: 952-525-4505
  • E-mail: ipl@umn.edu

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

25 let až 65 let (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: N/A
  • Intervenční model: Přiřazení jedné skupiny
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Lék: 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.

Ostatní jména:
  • 4-fosforyloxy-N,N-dimethyltryptamin
Behaviorální: 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.

Ostatní jména:
  • DBT + PAT

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Incidence, Severity, and Frequency of Adverse Events
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in Zanarini Rating Scale Score
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

University of Minnesota

Spolupracovníci

Filament Health Corp.

Vyšetřovatelé

  • Vrchní vyšetřovatel: Ziad Nahas, MD, MSCR, University of Minnesota
  • Ředitel studie: Devin H Hanson, PhD, LP, University of Minnesota

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. prosince 2026

Primární dokončení (Odhadovaný)

31. prosince 2029

Dokončení studie (Odhadovaný)

31. prosince 2030

Termíny zápisu do studia

První předloženo

10. září 2026

První předloženo, které splnilo kritéria kontroly kvality

16. září 2026

První zveřejněno (Aktuální)

22. září 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

22. září 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

16. září 2026

Naposledy ověřeno

1. září 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • PSYCH-2026-35016
  • STUDY00029130 (Jiný identifikátor: University Of Minnesota- IRB)

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ano

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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