AI Article Synopsis
- The study focused on evaluating the safety and effectiveness of psilocybin for patients with severe treatment-resistant depression (TRD), who had not benefited from at least five previous treatments.
- Conducted over 12 weeks at Sheppard Pratt Hospital, patients received a single 25 mg dose of synthetic psilocybin and underwent therapy sessions before and after dosing, assessing their depression levels mainly with the Montgomery-Åsberg Depression Rating Scale (MADRS).
- Results showed significant reductions in depressive symptoms at both 3 weeks and 12 weeks post-treatment, indicating psilocybin’s potential as a viable option for individuals with severe TRD, although those with comorbid PTSD experienced less improvement.
Article Abstract
Objective: Depression varies along a difficulty-to-treat spectrum. Patients whose illness fails to respond to at least five treatments may be considered to have severely treatment-resistant depression (TRD). The objective of this study was to document the safety and efficacy of psilocybin in patients with severe TRD.
Methods: This was a 12-week, open-label trial conducted at Sheppard Pratt Hospital. Participants were 18-65 years of age, in a major depressive episode with documented insufficient benefit from at least five treatments during the current episode. A single dose of synthetic psilocybin (25 mg) was administered. Psychotropic medications were discontinued at least 2 weeks prior to dosing through at least 3 weeks post-dosing. Therapists met with patients for three sessions during pretreatment, during the 8-hour dosing day, and for three integration sessions posttreatment. The primary outcome measure was change in Montgomery-Åsberg Depression Rating scale (MADRS) at 3 weeks posttreatment. Secondary measures including MADRS scores up to 12 weeks posttreatment, and subject-rated scales capturing depression and level of function were completed at baseline and all subsequent visits.
Results: Twelve participants (six male, six female; mean age=40.6 years [SD=9.6]) with severe TRD were followed over the study period. Depressive symptoms were significantly decreased at week 3 (MADRS least-squares mean change=-15.8, 95% CI=-25.4 to -6.3) and Week 12 (MADRS least-squares mean change=-17.2, 95% CI=-25.2 to -9.1). In exploratory analyses, the Oceanic Boundlessness (OB) dimension of the psychedelic experience correlated with post-dosing antidepressant responses. Patients with comorbid PTSD (N=5) showed significantly less antidepressant effect of psilocybin.
Conclusions: This open-label study suggests efficacy and safety of psilocybin in severe TRD and supports further study of psychedelics in this population, including consideration of PTSD interaction effects.
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Source |
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| http://dx.doi.org/10.1176/appi.ajp.20231063 | DOI Listing |
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