This Phase III interventional trial (n=20), conducted by the University of North Carolina, Chapel Hill, aims to assess the efficacy and safety of Psilocybin-Assisted Therapy (PAT, 25mg, 2x) in adults with treatment-resistant depression (TRD).
The study will compare the outcomes of participants who receive one treatment session of psilocybin-assisted therapy with those who receive two treatment sessions spaced two weeks apart. A total of 20 participants are estimated to be enrolled, with ages ranging from 18 to 70 years.
Participants meeting eligibility criteria, including a DSM-V diagnosis of major depressive disorder and failure to respond to at least two guideline-concordant pharmacological treatments, will undergo one or two treatment sessions involving the administration of 25mg of psilocybin.
The primary outcome measures include changes in depression severity assessed by the Hamilton Depression Rating Scale (HAM-D-17) and the Quick Inventory of Depressive Symptomatology Short Response-16 (QIDS SR-16) scores at various time points up to 12 months after treatment.
Secondary outcome measures include the number of participants achieving remission and response at different time points, as well as the time to relapse in those who initially responded to treatment.
This trial is designed as a randomized, parallel assignment study, with single masking of outcomes assessors. The study will provide valuable insights into the effectiveness of psilocybin-assisted therapy as a potential treatment for TRD. Recruitment for this trial began in April 2024, and the estimated primary completion date is September 2025, with a study completion date estimated for September 2026.
Trial Details
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