Inflammatory response to psilocybin in treatment-resistant depression

  • Research type

    Research Study

  • Full title

    Measurement of blood inflammatory marker levels in samples collected as part of a clinical trial of psilocybin for treatment-resistant depression

  • IRAS ID

    357453

  • Contact name

    Luke Baxter

  • Contact email

    luke.baxter@kcl.ac.uk

  • Sponsor organisation

    King's College London

  • Clinicaltrials.gov Identifier

    NCT07164755, NCT number

  • Duration of Study in the UK

    1 years, 0 months, 1 days

  • Research summary

    About a third of people with clinical depression will be affected by treatment-resistant depression, which means that their symptoms do not improve with the antidepressants that are currently available. People with treatment-resistant depression tend to be more unwell, for longer. They also are at greater risk of severe complications of depression, such as suicide.

    When the body responds to disease or injury, it produces signals that activate the immune system. This process is known as ‘inflammation’. Inflammation is important for keeping the body safe, but it can be harmful if it happens excessively, or at the wrong time or place. There is evidence to suggest that inflammation contributes to the development of treatment-resistant depression.

    Psilocybin is a psychedelic drug – at higher doses it causes people to hallucinate and have unusual thoughts. In clinical trials, a moderate dose has also been found to improve the symptoms of treatment-resistant depression. One of the ways it may do this is by reducing inflammation and we know that psilocybin has this effect from previous studies using animals. However, the relationship between inflammation and changes in symptoms of depression in humans following psilocybin treatment remain unclear.

    In a recent clinical trial (called PsiDeR), blood samples were collected from patients with treatment-resistant depression both before and after they were given psilocybin.

    My project would involve testing this samples for levels of key inflammatory markers in blood. This would help us determine: 1) whether the levels of inflammatory markers can predict which people with treatment-resistant depression have the most benefit from psilocybin, 2) whether the levels of inflammatory markers are altered following psilocybin treatment, and 3) whether the change in inflammatory markers is correlated with the change in depression symptoms.

  • REC name

    North West - Preston Research Ethics Committee

  • REC reference

    25/NW/0335

  • Date of REC Opinion

    1 Dec 2025

  • REC opinion

    Further Information Favourable Opinion