COMP 006

About the study

The COMP006 study is suitable for people who have been diagnosed with depression and are currently experiencing a single or recurring episode which has not responded to antidepressant treatment.

The study has three parts (A, B, C) and will last up to 62 weeks, including a three- to ten-week screening period. Part A will include two administrations of COMP360, delivered three weeks apart with psychological support, in a specialised treatment room. The doses delivered will be one of three potential strengths, chosen at random by a computer and will not be revealed to the participant or the study team. Part B and C will be focused on follow-up, with potential for re-treatment if criteria are met. Retreatment in part B will be with the same dose assigned at part A, also unknown to the participant and the team. In Part C, however, re-treatment will be with a fixed dose, known to the participant and the team.

Participants will receive support from study doctors to help them taper off certain medications, including antidepressants, before administration.

Payment for travel and other expenses will be available if required.

Who can take part?

Participants may be eligible to participate in a COMP006 if they:

• Are 18 years of age or older
• Have been diagnosed with depression (single or recurrent episodes)
• Are experiencing treatment-resistant depression, defined as failing 2, 3 or 4 medications for your current episode of depression.
• Happy to discontinue current antidepressant medication.
• Meet additional study criteria.

For more information, please visit www.comp006study.com. You can also contact the Principal Investigator, Dr Mourad Wahba, or Trial Co-ordinators, Mr Michael Kelly and Ms Sara-Jaye Long on psilocybinteam@cntw.nhs.uk.