psilocybin low-dose / Diamond Therap - LARVOL DELTA

Differential effects of psilocybin and lisuride on serotonin and dopamine neuronal activity and behavior. (PubMed, Prog Neuropsychopharmacol Biol Psychiatry) - "Although both drugs target 5-HT2A receptors, they engage distinct neurobiological pathways. Psilocybin produces psychedelic-like, 5-HT-dominant effects, whereas lisuride displays DA-linked improvements in coping behavior, informing future development of serotonergic therapeutics."

Journal

Differential effects of Psilocybin and Lisuride on Serotonin and Dopamine neuronal activity and behavior (CINP-AsCNP 2025) - "These results suggest that lisuride has antidepressant and sedative effects without producing HTR, likely due to its differential action on 5-HT and DA neurons. Lisuride inhibits the serotoninergic system, like psilocybin. However, the actions in which these two drugs use are different, with only psilocybin's effect at the 5-HT2A receptor."

CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Safety, Tolerability, and Preliminary Efficacy of Psilocybin Oral Solution in Adults With Generalized Anxiety Disorder (clinicaltrials.gov) - P2 | N=50 | Recruiting | Sponsor: Queen's University

New P2 trial • CNS Disorders • General Anxiety Disorder • Mood Disorders • Psychiatry

Exploratory Study of Low Dose Psilocybin (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: University of Alabama at Birmingham | Trial completion date: Dec 2024 ➔ Dec 2025 | Trial primary completion date: Dec 2024 ➔ Dec 2025

Trial completion date • Trial primary completion date

Psilocybin vs. lisuride: similarities and differences in their serotonergic, dopaminergic, sedative-, anxiogenic-, and antidepressant-like effects (Neuroscience 2024) - "Both drugs decrease 5-HT cell firing but only psilocybin’s effect was 5-HT2A mediated, only psilocybin produced an anxiolytic-like effect, and only lisuride yielded an antidepressant-like effect. Further research is ongoing to better understand the intrinsic activity of these compounds on 5-HT and DA sub-receptors in different areas."

CNS Disorders

Exploratory Study of Low Dose Psilocybin (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: University of Alabama at Birmingham | Trial completion date: Mar 2024 ➔ Dec 2024 | Trial primary completion date: Mar 2024 ➔ Dec 2024

Trial completion date • Trial primary completion date

Exploratory Study of Low Dose Psilocybin (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: University of Alabama at Birmingham | Not yet recruiting ➔ Recruiting | Trial completion date: Dec 2023 ➔ Mar 2024 | Trial primary completion date: Dec 2023 ➔ Mar 2024

Enrollment open • Trial completion date • Trial primary completion date

Exploratory Study of Low Dose Psilocybin (clinicaltrials.gov) - P1 | N=60 | Not yet recruiting | Sponsor: University of Alabama at Birmingham | Trial completion date: Aug 2023 ➔ Dec 2023 | Trial primary completion date: Aug 2023 ➔ Dec 2023

Trial completion date • Trial primary completion date

Exploratory Study of Low Dose Psilocybin (clinicaltrials.gov) - P1 | N=60 | Not yet recruiting | Sponsor: University of Alabama at Birmingham | Trial completion date: May 2023 ➔ Aug 2023 | Initiation date: Dec 2022 ➔ Mar 2023 | Trial primary completion date: Apr 2023 ➔ Aug 2023

Trial completion date • Trial initiation date • Trial primary completion date

Exploratory Study of Low Dose Psilocybin (clinicaltrials.gov) - P1 | N=60 | Not yet recruiting | Sponsor: University of Alabama at Birmingham | Initiation date: May 2022 ➔ Aug 2022

Trial initiation date

Exploratory Study of Low Dose Psilocybin (clinicaltrials.gov) - P1 | N=60 | Not yet recruiting | Sponsor: University of Alabama at Birmingham

New P1 trial

Diamond Therapeutics Announces Health Canada Approval of Clinical Trial with Low-Dose Psilocybin (PRNewswire) - "Diamond Therapeutics Inc...is pleased to announce that it has received a No Objection Letter from Health Canada, allowing Diamond to proceed with a human clinical trial to evaluate low doses of psilocybin in healthy volunteers. The trial is a Phase 1 randomized, placebo-controlled, double-blind study to evaluate the safety and pharmacokinetics of low doses of psilocybin in as many as 80 study participants....Diamond is also planning to launch a Phase 2 trial to investigate low-dose psilocybin's efficacy in treating anxiety...This Phase 2 study will be conducted in both Canada and the U.S. As well, Diamond plans to support an investigator-led study of low-dose psilocybin in the U.S. to explore its effects on patients with moderate depression."

New P1 trial • CNS Disorders • Depression • General Anxiety Disorder