Evergreen

Researchers are evaluating the safety and effectiveness of TSND-201 in adults diagnosed with Post Traumatic Stress Disorder PTSD who have had symptoms for at least six months. The study involves participants who have previously tried at least one medication or trauma-focused psychotherapy for PTSD. This phase 3 randomized, double-blind, placebo-controlled trial aims to compare two doses of TSND-201 capsules with a placebo to better understand treatment options for PTSD. Participants will enter a 4-week Treatment Period during which they will be randomly assigned to receive either one of two doses of TSND-201 or a placebo capsule once a week, taken orally. After completing this treatment phase, they will continue into an 8-week Follow-up Period to monitor their progress and any changes in their condition. The study uses a parallel design and masking to keep participants and researchers unaware of group assignments. During the study, participants will undergo assessments including the Clinician-Administered PTSD Scale for DSM-5 CAPS-5 to measure changes in PTSD severity from the start through 12 weeks. Researchers will also monitor safety and efficacy by evaluating participants regularly through interviews and questionnaires. The entire participation duration covers 12 weeks, including treatment and follow-up, with safety and response being closely observed throughout.

Researchers are evaluating ALTO-300, a drug taken as a capsule once daily in the evening, for adults with moderate to severe major depressive disorder MDD. The study aims to compare the effects of ALTO-300 versus a placebo when added to an antidepressant, focusing on how patient characteristics may influence treatment outcomes. This is a randomized, double-blind trial with a phase 2 design. Participants will be randomly assigned to receive either ALTO-300 or a matching placebo capsule once daily for 42 days during the double-blind period. Those who qualify may then enter an open-label extension period lasting up to 8 weeks, during which all participants receive ALTO-300 once daily. The trial includes careful monitoring throughout both treatment periods. During the study, participants will undergo assessments to measure changes in depression symptoms using the Montgomery-sberg Depression Rating Scale MADRS up to week 6. Safety evaluations include tracking adverse events, heart rate, weight, blood pressure, and suicidality over the course of up to 15 weeks. The total participation duration may extend to 14 weeks, including both blinded and open-label phases, with regular visits and evaluations.