Psilocybin, the chemical component of "magic mushrooms", has been administered with psychological support in several randomized clinical trials (RCTs) showing large and sustained antidepressant effects.
The purpose of this study is to determine the role of psilocybin monitors on the effects of psilocybin therapy in adults with treatment resistant depression.
Adults 18 to 70 years old;
Are outpatients;
Must be deemed to have capacity to provide informed consent;
Must read, sign and date the informed consent form independently. Proxy consent, including consent from a Legally Authorized Representative (LAR), is not permitted in this study;
Pregnant as assessed by a urine pregnancy test at Screening (V1) and Baseline (V2) or individual's that intend to become pregnant during the study or are breastfeeding;
Treatment with another investigational drug or other intervention within 30 days of Screening (V1);
Brain stimulation treatment within 6 months of Screening (V1);
Use of psychedelics within 6 months of Screening (V1);
Parallel
Psilocybin
Drug25 mg Psilocybin
Feasibility of evaluating the role of psilocybin monitors in a clinical trial of psilocybin therapy for treatment resistant depression
Percentage of participants recruited, randomized, and retained
Tolerability and safety of administering psilocybin therapy (25 mg) for treatment resistant depression
Type and number of adverse effects or serious adverse events
Click on the lead sponsor to view all of their trials.
Centre for Addiction and Mental Health
Lead sponsor
University Health Network, Toronto
Collaborator
