Randomized Double-Blind Study of ALTO-300 Added to Antidepressants for Adults with Major Depressive Disorder Including an Open-Label Extension Phase

What this Trial Is About

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.

Study of ALTO-300 in MDD