Clinical TrialCompleted

Imperial College London Open-Label Psilocybin Pilot for Treatment-Resistant Depression (Carhart-Harris / Lyons 2016–2018)

Open-label, uncontrolled pilot study of oral psilocybin for treatment-resistant depression at Imperial College London (Front Psychol 2018; Lyons T, Carhart-Harris RL; PMID 30369890; DOI 10.3389/fpsyg.2018.01721; also reported: Carhart-Harris et al. Lancet Psychiatry 2016 n=12, Neuropharmacology 2018 n=20). n=15 TRD patients + 15 healthy controls matched on age/gender/education. Patients: clinically assessed TRD. Intervention: oral psilocybin 10 mg (safety dose) one week before oral psilocybin 25 mg (treatment dose); unblinded, open-label. Outcomes in this paper: future-event forecasting (optimism bias test) at baseline and 1 week post-25 mg session; QIDS-SR depression at baseline and 1 week. Neither patients nor research team masked to treatment. UK regulatory/ethics approval obtained. No CT.gov registration found (searches by PMID, Carhart-Harris, and TRD+psilocybin+UK). Possible ISRCTN or NHS HRA registration not confirmed from available metadata.

Target Enrollment
20 participants
Study Type
interventional
Design
Non-randomized

Study Details

  • Status
    Completed
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment20 participants
  • Timeline
    Start: 2015-01-01
    End: 2016-12-31

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