University of New Mexico Researchers: All Psilocybin Study Participants to Receive Active Dose

Press Release: University of New Mexico

University of New Mexico Health Sciences researchers are launching two new psilocybin-related studies looking at its potential for treating postpartum depression and major depressive disorder. Researchers have designed the trials to ensure that all participants will eventually receive an active dose.

Reconnect is a Phase 2 multi-center study of RE104 – a novel compound that’s related to psilocybin – for postpartum depression, which affects about 13% of new mothers.

“The exciting thing about this one is it has the potential to quickly reverse postpartum depression,” said Larry Leeman, a professor in the departments of Family and Community Medicine in the UNM School of Medicine.

Some participants in the double-blind placebo-controlled study will receive a one-time injection of the short-acting drug, whose psychedelic effects peak at about 2 1/2 hours, he said.

“I have an interest because it might be useful in cases where a shorter experience might be more useful,” Leeman said.

While some people experiencing postpartum depression have a pre-existing mood disorder, many experience it only as an outcome of pregnancy, and might need just one treatment session to recover, he said. Psilocybin has been shown to have effect on major depression within a few days, which may be particularly beneficial for mothers whose postpartum depression may be affecting maternal-infant bonding. It can only be used for people who are not breastfeeding, however.

RE104 is also being explored for treating patients with life-threatening cancer diagnoses who are experiencing depression and anxiety, he said. Leeman expects UNM will probably participate in that study, starting in 2025.

The other new study, dubbed uAspire, is a Phase 3 randomized, double-blind multicenter project assessing the potential benefits of psilocybin for major depressive disorder.

UNM’s portion of the study is planned for 15 to 20 participants, Leeman said.

The study is designed so that everyone who enters it can eventually receive psilocybin, he said.

“This is an issue with randomized controlled trials, especially if you take people that are in emotional pain,” he said. Study participants who desperately hope a trial medication will alleviate their distress may actually feel worse if they receive an inactive placebo. “It’s like a negative placebo – a nocebo,” Leeman said.

UAspire will follow participants for 54 weeks, randomizing some participants to 25 mg of psilocybin – a moderate-to-high dose – while others will receive a smaller 5 mg dose or an inactive placebo.

Six weeks later, participants get re-scored for depression. If they meet the criteria, they can be re-dosed in the open-label session for a total of four times in the next year,” he said.

“It’s a really pragmatic trial,” Leeman said. “Even if you do your session and don’t feel like you have the active drug, you know that in six weeks if you’re still depressed you’ll receive the 25 mg psilocybin dose. I think this will minimize the likelihood of their depression worsening if they believe they did not receive psilocybin.”