Article ; Online: Psilocybin-assisted psychotherapy for treatment resistant depression: A randomized clinical trial evaluating repeated doses of psilocybin.
Med (New York, N.Y.)
2024 Volume 5, Issue 3, Page(s) 190–200.e5
Abstract: 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, ...
| Abstract | 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. |
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| MeSH term(s) | Adult ; Humans ; Psilocybin/adverse effects ; Depressive Disorder, Major/drug therapy ; Depressive Disorder, Major/chemically induced ; Depressive Disorder, Treatment-Resistant/drug therapy ; Antidepressive Agents/adverse effects ; Psychotherapy |
| Chemical Substances | Psilocybin (2RV7212BP0) ; Antidepressive Agents |
| Language | English |
| Publishing date | 2024-02-14 |
| Publishing country | United States |
| Document type | Randomized Controlled Trial ; Journal Article |
| ISSN | 2666-6340 |
| ISSN (online) | 2666-6340 |
| DOI | 10.1016/j.medj.2024.01.005 |
| Database | MEDical Literature Analysis and Retrieval System OnLINE |
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