Exploratory trial to assess the efficacy and safety of Psilocybin-Assisted Psychotherapy (PAP) involving family-members compared to standard PAP, in adults with treatment-resistant major depressive disorder. (TRMDD)

This interventional trial (n=60) will assess the efficacy and safety of Psilocybin-Assisted Psychotherapy (PAP/PAT) involving family members in adults with treatment-resistant major depressive disorder (TRMDD). The study will compare two groups, one where PAT involves family members and another where PAT is conducted solely with therapists.

All participants will receive two doses of 25 mg of psilocybin three weeks apart. The primary outcome will be measured using the Hamilton Depression Rating Scale (HDRS) and the Montgomery–Åsberg Depression Rating Scale (MADRS) 12 months following the last psychotherapy session.

Trial Details

All participants will receive two separate doses of 25 mg of psilocybin 3 weeks apart from each other. in the form of a capsule Which they will take orally with water in the presents of the approved treating team members. This is in line with the schedule 9 licence agreement. They will be asked to consent verbally before receiving each dose. To minimise the risk of PAP-related nausea and vomiting, they should fast eight hours prior to receiving the dose and not drink anything 30 minutes prior to receiving psilocybin. When administered the psilocybin, each participant will be accompanied and monitored at all times by the treating therapists for a minimum of 6 hours (until the acute psychological effects of the drug wear off) and a medically qualified person that will be available at all times. Group 1: The treating Clinical Psychologists (Two will be always present) will remain in the room with the participant. The supporting family member will only be present for the Preparation period of the study and will not be present during the treatment sessions. Active Psychotherapy will take place following medication administration. During the preparation session, the family member will get to meet the therapists that will be with them during the entire study. Throughout this session, the therapists will explain the study team’s expectations on how they are to conduct yourself during and after each PAP session. This baseline visit/visit 3 may take approximately 2.5 hours. They are encouraged and must feel free to ask any questions you feel like asking. Group 2: The treating Clinical Psychologists (Two will be always present) will remain in the room with the participant. Active Psychotherapy will take place following medication administration.

NCT Number ACTRN12623000618651

Data attribution

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