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A Phase III, Multicentre, Randomised, Double-blind, Controlled Study to Investigate the Efficacy, Safety, and Tolerability of Two Administrations of COMP360 in Participants With Treatment-resistant Depression

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Trial Profile

A Phase III, Multicentre, Randomised, Double-blind, Controlled Study to Investigate the Efficacy, Safety, and Tolerability of Two Administrations of COMP360 in Participants With Treatment-resistant Depression

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 30 Mar 2025

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At a glance

  • Drugs Psilocybin (Primary)
  • Indications Depression
  • Focus Registrational; Therapeutic Use
  • Acronyms COMP 006
  • Sponsors COMPASS Pathways

    • Most Recent Events

    • 10 Jan 2025 According to a COMPASS Pathways media release, the company announced the pricing of an offering. The company intends to use the net proceeds from this offering to fund this study.
    • 31 Oct 2024 According to a COMPASS Pathways media release, the company has decided to shift the data release for COMP006 until after the 26-week time point and the completion of the blinded portion has been reached for all patients to protect against the risk of unblinding. With this change, the company now expects data for COMP006 in the second half of 2026.
    • 15 Nov 2023 According to a COMPASS Pathways media release, company announced he initiation of the UK component of this study of investigational COMP360 psilocybin treatment in treatment-resistant depression.The research will take place in multiple sites in the UK, including at the Centre for Mental Health Research and Innovation in London, which officially opened today. Company announced the initiation of UK component of this study following Medicines and Healthcare Regulatory Agency Approval of study.

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