PSiGAD2

• Research type

  Research Study

• Full title

  A Phase IIb Multicentre, Randomised, Double-Blind, 2-Arm Trial Comparing the Efficacy and Safety of 25 mg Psilocybin plus Psychological Support versus 5 mg Psilocybin plus Psychological Support in Adults with Severe Generalized Anxiety Disorder (GAD) (PSiGAD2).

• IRAS ID

  1009576

• Contact name

  Mark Bleackley

• Contact email

  mark@incannex.com.au

• Sponsor organisation

  Incannex

• ISRCTN Number

  ISRCTN14487299

• Research summary

  This is a randomised, double-blind trial with two treatment arms, comparing the efficacy and safety of 5mg psilocybin plus psychological support with 25mg psilocybin with psychological support in adults with a diagnosis of generalised anxiety disorder (GAD) who may or may not be taking selective serotonin reuptake inhibitors (SSRIs). Approximately 94 participants with GAD who are still experiencing moderate to severe symptoms will receive two separate doses of either 5mg of psilocybin or 25mg psilocybin, one month apart in combination with psychological support. The primary objective is to assess the reduction of GAD symptoms as measured using the Hamilton Anxiety Scale (HAM-A) at week 8.
  Participants will take part in a screening period of up to 4 weeks, a treatment period of 7 weeks and a follow-up period of 22 weeks. In total, participants will take part for up to 33 weeks.

• REC name

  East of Scotland Research Ethics Service REC 2

• REC reference

  24/ES/0060

• Date of REC Opinion

  24 Sep 2024

• REC opinion

  Further Information Favourable Opinion