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Psilocybin Trial in Treatment-Resistant Depression Shows Mixed Results

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A phase 2b randomized clinical trial assessed the efficacy of psilocybin-assisted psychotherapy on treatment-resistant depression (TRD) but found no significant improvement in response rates at 6 weeks. The study involved 144 adults who had ceased antidepressant therapy. Participants received either 25 mg or 5 mg of psilocybin or a placebo (nicotinamide) combined with psychotherapy. Although primary endpoints were not met, higher doses showed early reductions in depressive symptoms. Methodological challenges, including functional unblinding and expectancy effects, complicate the interpretation of results, which need further research.

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