CYB003 for Depression

(EXTEND Trial)

This trial focuses on assessing the long-term safety and effectiveness of CYB003 for treating major depressive disorder (MDD). Participants from previous CYB003 studies who either did not initially respond or responded but later relapsed will receive additional doses of CYB003. This trial suits those who completed earlier CYB003 trials and maintained the same dose of their antidepressant medication. As a Phase 3 trial, it represents the final step before FDA approval, providing participants an opportunity to contribute to the potential availability of a new MDD treatment.

No, you do not need to stop your current medications. Participants must continue the same antidepressant medication at a stable dose throughout the trial.

In a previous study, all participants responded positively to treatment with CYB003, and 71% were in remission 12 months after receiving just two 16 mg doses. This outcome suggests the treatment is well-tolerated. Research has also shown strong and lasting improvements in depression symptoms. The studies tested both the effectiveness and safety of CYB003, yielding positive results.

Unlike the standard treatments for depression, which often include SSRIs or SNRIs, CYB003 is unique because it is a synthetic form of psilocybin, a compound found in psychedelic mushrooms. Researchers are excited about CYB003 because it targets the serotonin receptors in the brain in a novel way, potentially leading to rapid and profound changes in mood. While traditional antidepressants can take weeks to show effects, CYB003 may offer quicker relief for those who don't respond to conventional treatments, or who relapse after initially responding. This potential for faster action and effectiveness in difficult cases makes CYB003 a promising candidate in the fight against depression.

Research has shown that CYB003 is promising for treating major depressive disorder (MDD). In earlier studies, all participants responded well to the treatment, and 71% were free of depression symptoms a year after receiving just two doses of 16 mg each. The treatment demonstrated strong and lasting improvements in symptoms over four months. CYB003, which participants in this trial will receive, is a modified version of a compound found in psychedelic mushrooms, known for its mood-enhancing effects. These findings suggest CYB003 could effectively reduce symptoms of depression.¹²³⁵⁶