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Life sciences · Phase 1 Trial
ClinicalTrials.gov · September 22, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Phase 1 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
The source did not state who this applies to in practice.
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What is missing. This record has no bottom line, key findings, reported figures, evidence dimensions. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07833761). This is a study registration, not published results. Lead sponsor: University of Minnesota. Recruitment status: NOT_YET_RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 18 participants (ESTIMATED). Conditions: Borderline Personality Disorder, Borderline Personality Pathology, Depressive Symptoms, Emotion Dysregulation, Suicidal Ideation. Interventions: DRUG: Psilocybin; BEHAVIORAL: Psilocybin-Assisted Therapy With Dialectical Behavior Therapy. Primary outcome measures: Incidence, Severity, and Frequency of Adverse Events , Baseline through final study visit at week 18; Acute Suicidal Ideation After Psilocybin Dosing , Within 24 hours after each dosing visit; Challenging Experiences After Psilocybin Dosing , Integration visit 24 hours after each dosing visit; Psilocybin-Related Side Effects , Integration visit 24 hours after each dosing visit; Percentage of Participants Who Complete the Study , Baseline through final study visit at week 18; Percentage of DBT Therapy Sessions Attended , Baseline through final study visit at week 18; Percentage of Study Assessments Completed , Baseline through final study visit at week 18. 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.