protocolSection identificationModule nctId: NCT06303739, orgStudyIdInfo id: 22-1421, briefTitle: Psilocybin-Assisted Therapy in Treatment-Resistant Depression, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-19, primaryCompletionDateStruct date: 2025-09, completionDateStruct date: 2026-09, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: University of North Carolina, Chapel Hill, class: OTHER, collaborators name: Foundation of Hope, North Carolina, descriptionModule briefSummary: The goal of this clinical trial is to test how well psilocybin-assisted therapy works in treating people with depression. The main questions this study aims to answer are:* Does psilocybin with assisted therapy help improve symptoms for people with depression?* How long do the effects of this treatment last?Participants will:* Take part in a couple of screening and preparation visits.* Be given psilocybin in one or two treatment sessions.* Attend a series of follow-up sessions over the following year.* Complete forms and surveys to test how their symptoms have changed and what they thought of their experience.Researchers will also compare whether one treatment or two treatments help improve symptoms more for participants., conditionsModule conditions: Refractory Depression, conditions: Treatment Resistant Depression, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants are randomized into one of two groups and will receive either one single treatment of psilocybin-assisted therapy with follow-up therapy and assessments or two treatments spaced two weeks apart with follow-up therapy and assessments., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Due to the nature of the study and limitations of study staffing, only those conducting assessments and ratings throughout the study will be masked to the treatments. All others, including participants, therapists, investigators, and study coordinator, will not be masked to the number of treatments a participant receives., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: psilocybin, outcomesModule primaryOutcomes measure: Change in HAM-D-17 Scores between Baseline and 2 Weeks after Treatment, primaryOutcomes measure: Change in QIDS SR-16 Scores between Baseline and 2 Weeks after Treatment, primaryOutcomes measure: Number of Participants Achieving Remission 2 Weeks after Treatment, primaryOutcomes measure: Number of Participants Achieving Response 2 weeks after treatment, secondaryOutcomes measure: Number of Participants Achieving Remission at 6 Weeks, secondaryOutcomes measure: Number of Participants Achieving Response at 6 Weeks, secondaryOutcomes measure: Number of Participants Achieving Remission at 3 Months, secondaryOutcomes measure: Number of Participants Achieving Response at 3 Months, secondaryOutcomes measure: Number of Participants Achieving Remission at 6 Months, secondaryOutcomes measure: Number of Participants Achieving Response at 6 Months, secondaryOutcomes measure: Number of Participants Achieving Remission at 9 Months, secondaryOutcomes measure: Number of Participants Achieving Response at 9 Months, secondaryOutcomes measure: Number of Participants Achieving Remission at 12 Months, secondaryOutcomes measure: Number of Participants Achieving Response at 12 Months, secondaryOutcomes measure: Time to Relapse in Participants Who Showed Remission at 2 weeks, secondaryOutcomes measure: Time to Relapse in Participants Who Showed Response at 2 Weeks, secondaryOutcomes measure: Change in HAM-D-17 Scores between Baseline and 6 Weeks after Treatment, secondaryOutcomes measure: Change in HAM-D-17 Scores between Baseline and 3 Months after Treatment, secondaryOutcomes measure: Change in HAM-D-17 Scores between Baseline and 6 Months after Treatment, secondaryOutcomes measure: Change in HAM-D-17 Scores between Baseline and 9 Months after Treatment, secondaryOutcomes measure: Change in HAM-D-17 Scores between Baseline and 12 Months after Treatment, secondaryOutcomes measure: Change in QIDS SR-16 Scores between Baseline and 6 Weeks after Treatment, secondaryOutcomes measure: Change in QIDS SR-16 Scores between Baseline and 3 Months after Treatment, secondaryOutcomes measure: Change in QIDS SR-16 Scores between Baseline and 6 Months after Treatment, secondaryOutcomes measure: Change in QIDS SR-16 Scores between Baseline and 9 Months after Treatment, secondaryOutcomes measure: Change in QIDS SR-16 Scores between Baseline and 12 Months after Treatment, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UNC Chapel Hill Medical Center, status: RECRUITING, city: Chapel Hill, state: North Carolina, zip: 27514, country: United States, contacts name: Mary Pruden, BA, role: CONTACT, contacts name: Robert K McClure, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Amanda Tow, MD, PhD, role: SUB_INVESTIGATOR, contacts name: Lindley Reynolds, MSW, role: SUB_INVESTIGATOR, geoPoint lat: 35.9132, lon: -79.05584, hasResults: False