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Nearly 20% of new moms have anxiety or depression, but a promising psychedelic treatment is on the horizon
In a Phase 2 trial, 77% of treated women improved and Phase 3 is planned for 200 participants.
About 1 in 5 women experience depression or anxiety during or after pregnancy, conditions the FDA addressed in February 2026 by granting luvesilocin breakthrough therapy status.
In an FDA Phase 2 study, 77% of postpartum women receiving a 30mg dose of luvesilocin showed significant improvement in their depression. Overall, 71% had no symptoms seven days after the psychedelic session.
The University of Colorado served as one of 35 participating sites for the trial, which enrolled 84 postpartum women. In contrast, most in the placebo group still had symptoms after seven days.
Phase 3 of the luvesilocin trial is slated to begin by the end of 2026 with 200 participants, including women who are still breastfeeding. This stage will confirm effectiveness and evaluate overall risks and benefits.
Colorado's 2023 Natural Medicine Health Act established the regulatory framework for psychedelic treatments. The first natural medicine healing centers opened in early 2026, creating infrastructure to administer these emerging therapies.