San Juan Capistrano

Researchers are evaluating the safety, tolerability, and effectiveness of CYB003, a Deuterated Psilocin Analog, compared to a placebo when added to current antidepressant treatment in adults with moderate to severe Major Depressive Disorder (MDD). This Phase III trial focuses on participants aged 18 to 85 years who have had inadequate response to a stable antidepressant dose, aiming to better understand how CYB003 might improve depressive symptoms. Participants receive oral doses of CYB003 or matching placebo along with manualized psychological support provided by trained facilitators. The treatment period includes multiple dosing sessions with monitoring and assessments throughout. Placebo is used as a comparator to evaluate the combined safety and efficacy of CYB003 in this population. During the study, participants undergo evaluations using the Montgomery-Åsberg Depression Rating Scale (MADRS) at several time points, including screening, baseline, and multiple days up to the end of treatment at Day 42. Researchers monitor symptoms, side effects, and overall safety. Participants provide informed consent and are assessed regularly to track changes in depression severity and any adverse events over the course of the study.

Researchers are evaluating the efficacy, safety, and tolerability of CYB003, a deuterated psilocin analog, as an additional treatment for adults with Major Depressive Disorder (MDD). This Phase III, multi-center, double-blind, randomized controlled study compares two active doses of CYB003 against a placebo in patients experiencing moderate to severe depression who have not adequately responded to stable antidepressant treatment. Participants will receive either one of two doses of CYB003 or a placebo, along with manualized psychological support provided by a facilitator. The study includes a screening period, a dosing period, and follow-up assessments. The psychological support sessions are standardized to assist participants during the trial. During the study, participants will be assessed using the Montgomery-Asberg Depression Scale (MADRS) at multiple time points including screening, baseline, and several days during treatment up to the trial's end at Day 84. Researchers will monitor symptoms of depression, safety, and tolerability throughout the trial. Participants will also undergo various evaluations to ensure adherence and safety during the study period, which spans approximately 12 weeks from screening through the final assessment.

Researchers are evaluating the safety and effectiveness of TSND-201 capsules for adults diagnosed with Post Traumatic Stress Disorder (PTSD). This Phase 3 trial includes participants who meet the DSM-5 criteria for PTSD with symptoms lasting at least six months and who have previously tried at least one pharmacological or trauma-focused psychotherapy treatment. The study aims to measure changes in PTSD severity using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). Participants will be randomly assigned in equal groups to receive either one of two doses of TSND-201 or a placebo. These treatments are given orally once a week over a four-week Treatment Period. After completing treatment, participants will enter an eight-week Follow-up Period to monitor ongoing effects and safety. During the study, participants will complete interviews and written questionnaires to assess their PTSD symptoms and overall health. Researchers will track changes in PTSD severity up to 12 weeks from the start of treatment. Safety monitoring will include assessments to ensure participants remain free from other significant illnesses and manage any side effects. The total participation time includes the four-week treatment and eight-week follow-up phases.