Does Psilocybin Require Psychedelic Effects to Treat Depression?

PHASE2RecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

July 1, 2023

Primary Completion Date

February 28, 2026

Study Completion Date

February 28, 2026

Conditions
Treatment-resistant Depression
Interventions
DRUG

Psilocybin 25 mg

The psilocybin used in this study meets quality specifications suitable for human research use. The active drug is encapsulated using a hydroxypropyl methylcellulose (HPMC) capsule and contains 25 mg of psilocybin. The psilocybin will be administered once during the trial in combination with either risperidone 1 mg or place. It will also be administered in conjunction with supportive therapy.

DRUG

Risperidone 1 MG

The risperidone is encapsulated using a cellulose capsule and contains 1 mg of risperidone. The risperidone will be administered once during the trial in combination with either psilocybin 25 mg or placebo. It will also be administered with supportive therapy.

DRUG

Placebo

The placebo will be administered once during the trial in combination with either risperidone 1 mg or psilocybin 25 mg.

Trial Locations (1)

M6J1H4

RECRUITING

Centre for Addiction and Mental Health, Toronto

All Listed Sponsors
lead

Centre for Addiction and Mental Health

OTHER