Psilocybin in Participants with P-TRD after compl. of COMP001&COMP003

• Research type

  Research Study

• Full title

  A Multicentre study to assess safety and efficacy of psilocybin in patients with treatment-resistant depression following completion of COMP 001 and COMP 003 trials (P-TRD LTFU))

• IRAS ID

  276783

• Contact name

  Allan Young

• Contact email

  allan.young@kcl.ac.uk

• Sponsor organisation

  COMPASS Pathways, Ltd

• Clinicaltrials.gov Identifier

  Not Applicable, Not Applicable

• Duration of Study in the UK

  2 years, 0 months, 0 days

• Research summary

  A recent open-label study of the effects of psilocybin in participants with treatment-resistant depression (TRD) showed rapid, significant decrease of depressive symptoms after treatment with psilocybin coupled with psychological support.

  The aim of this study is to follow up participants from COMP 001 and COMP 003 in a long-term follow up study, with both remote and digital assessments, to explore the long term efficacy and safety of the three different doses of psilocybin (1 mg, 10 mg, and 25 mg) administered to patients with TRD as a monotherapy in COMP 001 and 25 mg psilocybin administered as an adjunct to an selective serotonin reuptake inhibitors (SSRI) in COMP 003.

  Approximately 150 participants will be enrolled into this study, at up to 20 different study centres across Europe and North America.

• REC name

  London - Queen Square Research Ethics Committee

• REC reference

  20/LO/0748

• Date of REC Opinion

  27 Aug 2020

• REC opinion

  Further Information Favourable Opinion