Psilocybin for Depression

(SPACE Trial)

This trial explores whether psilocybin, a psychedelic compound, can reduce symptoms of major depressive disorder (MDD) when administered under general anesthesia. The anesthesia masks psilocybin's psychological effects, keeping both participants and researchers unaware of who receives the active treatment, which ensures more reliable results. Participants will be randomly assigned to receive either psilocybin or a placebo in four sessions. Individuals diagnosed with MDD who can safely undergo general anesthesia might be suitable for this trial. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

Yes, you may need to stop taking certain medications to participate in this trial. Specifically, you cannot take certain antidepressants, antipsychotics, anticonvulsants, and other medications that might interact with psilocybin. It's best to discuss your current medications with the study staff to see if they are allowed.

Previous studies have generally found psilocybin to be well-tolerated by most participants. Research shows that while psilocybin might cause side effects, these are usually mild to moderate. Nausea is the most common side effect, with one study noting a higher likelihood of its occurrence. However, serious side effects were rare.

Most treatments for depression, like SSRIs and SNRIs, work by adjusting neurotransmitters such as serotonin in the brain over several weeks. Psilocybin, however, is unique because it acts as a psychedelic compound that may rapidly reset brain circuits associated with mood and perception. Researchers are excited about psilocybin because it has the potential to provide fast-acting relief, sometimes within hours, and it may lead to lasting changes after just a few sessions. This offers a promising alternative to the long wait times associated with traditional antidepressants, potentially transforming how depression is treated.

Research has shown that psilocybin can greatly reduce symptoms of major depressive disorder (MDD). Studies have found that a 25 mg dose of psilocybin often leads to a significant drop in depression symptoms for many people. These positive effects can last up to a year, offering long-term relief. In past trials, more than half of the participants experienced improved depressive symptoms. Most also reported feeling better overall without serious side effects. This evidence suggests that psilocybin could be a promising treatment for MDD. In this trial, participants will receive different doses of psilocybin, including 10 mg and 25 mg, as well as a placebo, across different sessions to evaluate its effectiveness and safety.¹⁵⁶⁷⁸