1-888-210-3553

1-888-210-3553

Psilocybin-assisted psychotherapy for treatment resistant depression: A randomized clinical trial evaluating repeated doses of psilocybin

Background

Psilocybin-assisted psychotherapy (PAP) has been associated with antidepressant effects. Trials to date have typically excluded participants with complex presentations. Our aim was to determine the feasibility of PAP in a complex population, including high levels of treatment resistance in major depressive and bipolar disorder and patients with baseline suicidality and significant comorbidity. We also evaluated flexible repeated doses over a 6-month period.

 

Methods

Adults with treatment-resistant depression as part of major depressive or bipolar II disorder without psychosis or a substance use disorder were eligible to participate. Subjects were randomized to immediate treatment or waitlist control, with all eventually receiving PAP. Participants had one, two, or three psilocybin sessions with a fixed dose of 25 mg. Each dose was accompanied by preparation and integration psychotherapy sessions. Acceptability, safety, tolerability, and efficacy were evaluated (this study was registered at ClinicalTrials.gov: NCT05029466).

 

Findings

Participants were randomized to immediate treatment (n = 16) or delayed treatment (n = 14). 29/30 were retained to the week-2 primary endpoint. Adverse events were transient, with no serious adverse events. Greater reductions in depression severity as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) were observed in the immediate treatment arm compared to the waitlist period arm with a large hedge’s g effect size of 1.07 (p < 0.01). Repeated doses were associated with further reductions in MADRS scores compared to baseline.

 

Conclusions

PAP was feasible in complex patients with preliminary antidepressant efficacy and adequate safety and tolerability. Repeated doses were associated with greater reductions in depression severity.

 

Funding

This work was funded by Brain and Cognition Discovery Foundation (BCDF), Usona, and Braxia Scientific.

Stay Updated On Psychedelic News

Join our newsletter to receive updates about the latest psychedelic news, hear about our ground-breaking research, and learn what we think about the latest trends shaping the future of psychedelics.

Planning Your Psychedelic Trip?
Our Info Line Can Help.

We provide 100% free, 1:1 guidance for anyone preparing for a psychedelic experience. Learn more about our evidence-based approach or book a call today.

Learn MoreBook a Call

About:

Conditions:

Research Keywords:

Pop-ups are annoying, but our emails aren't!

We hate pop-ups as much as you do, but if you want to stay up to date about the latest news in the psychedelic space and learn about our ground-breaking psychedelic research, please consider signing up for our newsletter below.