Results From a Long-Term Observational Follow-Up Study of a Single Dose of Psilocybin for a Treatment-Resistant Episode of Major Depressive Disorder

Summary & key facts

This study followed people with treatment-resistant major depression for 52 weeks after a single dose of COMP360 psilocybin. Overall, the 25 mg group showed a longer time before a prespecified return of depressive symptoms than the 10 mg and 1 mg groups. The authors say the 25 mg result is suggestive but that larger long-term studies are needed to confirm these findings.

Key facts:

• Sixty-six participants entered the COMP 004 follow-up (58 came from COMP 001 and 8 from COMP 003).
• For all COMP 001 patients (n = 233), median time to a prespecified depressive event was 92 days for 25 mg, 83 days for 10 mg, and 62 days for 1 mg of COMP360.
• By Week 12, most participants in COMP 001 had a depressive event: 25 mg group 37/75, 10 mg group 38/79, 1 mg group 44/75.
• In a post hoc analysis of COMP 001 participants who enrolled in COMP 004, median time to depressive event was 189 days for 25 mg, 43 days for 10 mg, and 21 days for 1 mg.
• Only 10 participants from COMP 001 experienced a depressive event after enrolling in COMP 004 (25 mg n = 6, 10 mg n = 3, 1 mg n = 1); none from COMP 003 had a depressive event during COMP 004.
• Few adverse events were reported after entry into COMP 004. One case of mild suicidal ideation in the 1 mg group was judged possibly related to the study drug.
• At COMP 004 entry, more people in the 1 mg group were taking antidepressant medication (n = 10) than in the 10 mg (n = 9) or 25 mg (n = 6) groups, and they generally started treatment earlier.

Abstract

Trial Registration: ClinicalTrials.gov identifier: NCT04519957.

Topics

Chemical synthesis and alkaloids Digital Mental Health Interventions Psychedelics and Drug Studies

Categories

Clinical Psychology Psychology Social Sciences

Tags

Cognition Hallucinogen Internal medicine Major depressive disorder Medicine Observational study Physics Psilocybin Psychiatry Psychology Quantum mechanics Term (time)

Substances

Psilocybin

Conditions & symptoms

Depression Sadness or low mood