Psilocybin in patients with fibromyalgia: EEG-measured brain biomarkers of action (Psilopain)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Mechanistic Study

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Within-subjects, single arm study

Study drug and medical condition

• Name of medicine, other:
  Psilocybin
• Medical condition to be studied:
  Fibromyalgia

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  20

Study design details

• Main study objective:
  The primary objective of this non-CTIMP (non-Clinical Trial of an Investigational Medicinal Product) early phase experimental medicine study is to utilise a within-subjects design to examine a candidate brain biomarker of increased plasticity (defined as the ability to change) under psilocybin, Lempel-Ziv complexity (LZc).
• Outcomes:
  1) Lempel-Ziv complexity (LZc) 2) The Brief Experiential Avoidance Questionnaire (BEAQ), 1) Structural and functional magnetic resonance imaging 2) Patient reported outcome measures 3) Physiology: Heart rate, body temperature, accelerometry 4) Qualitative interviews
• Data analysis plan:
  With an assumption of high co-linearity between core outcomes we will explore data reduction approaches (e.g. factor or principal component analyses or canonical correlation analysis) to investigate key contrasts. Two tailed tests will be performed if findings are not aligned with prior hypotheses. Due to prior hypotheses on directionality, one tailed t-tests will be performed when appropriate. Multiple comparisons corrections and Bayesian analyses will be performed where deemed appropriate.