The purpose of this study is to see if psilocybin, an investigational drug, is safe and well tolerated. Researchers also want to know if psilocybin can improve symptoms of depression.
This study will see if psilocybin is safe and well tolerated by tracking changes in suicidal thoughts and behaviour, monitoring if any participants choose to stop participating in the study, and measuring any serious side effects, as well as how long they take to resolve.
This study will also see if depression symptoms improve (or worsen) after psilocybin is administered. Additional information about participants’ depressive symptoms and side effects will also be measured during the study.
Compound Psilocybin
Country Canada
Visit trial
Status
Completed
Results Published
No
Start date
19 November 2021
End date
28 February 2023
Chance of happening
100%
Phase
Phase II
Design
Open
Type
Interventional
Generation
First
Participants
30
Sex
All
Age
18- 99
Therapy
No
Trial Details
This randomized clinical trial will assess the feasibility, safety, and efficacy of single and repeat doses of psilocybin at point-of-care in persons with treatment-resistant depression as part of major depressive disorder or bipolar II disorder. The primary objective is to evaluate the feasibility of psilocybin in adults with treatment-resistant depression. The secondary objectives are to assess the efficacy and tolerability of psilocybin at point-of-care.NCT Number NCT05029466
Sponsors & Collaborators
Canadian Rapid Treatment Centre of ExcellenceEstablished in 2018 the Canadian Rapid Treatment Centre of Excellence offers ketamine therapy to aid those suffering from several treatment-resistant conditions such as depression and bipolar disorder.
Braxia Scientific
Braxia Scientific Corp (previously Champignon Brands and Apotheosis Scientific) is one of the for-profit companies developing therapies in conjunction with psychedelics. In its short history, it has acquired a psilocybin research firm Tassili Life Sciences, a mushroom cultivator (Artisan Growers), and has recently started offering esketamine treatments for MDD.
Brain and Cognition Discovery Foundation
This company doesn't have a full profile yet, it is linked to a clinical trial.
Papers
Psilocybin-assisted psychotherapy for treatment resistant depression: A randomized clinical trial evaluating repeated doses of psilocybinThis open-label waitlist trial (n=30) assessed the feasibility of psilocybin-assisted psychotherapy (PAP/PAT) in a complex population with treatment-resistant depression (TRD), including major depressive and bipolar II disorders, baseline suicidality, and significant comorbidity. Participants received one, two, or three sessions of PAP with psilocybin (25mg), accompanied by preparation and integration psychotherapy sessions. Immediate treatment showed greater reductions in depression severity (MADRS) compared to the waitlist period, with a large effect size (g = 1.07, p < 0.01). Repeated doses were associated with further reductions in depression severity. Adverse events were transient, and the study demonstrated feasibility, preliminary antidepressant efficacy, safety, and tolerability in this population.