Study of ACP-211 Medicine for Adults 18 to 65 With Major Depressive Disorder Not Improved by Antidepressants

What this Trial Is About

Researchers are evaluating ACP-211 as a monotherapy for adults aged 18 to 65 with major depressive disorder MDD who have not improved with antidepressant therapy, including treatment-resistant depression. The study aims to determine if ACP-211 reduces depression symptoms better than a placebo and to monitor any adverse events. This is a randomized, double-blind, placebo-controlled Phase 2 trial conducted by ACADIA Pharmaceuticals Inc. Participants are randomly assigned to receive either 600 mg or 300 mg of ACP-211, or a matching placebo, all administered orally twice weekly. The study lasts for 28 days, during which participants take their assigned capsules. The trial uses a parallel group design to compare the effects of the two ACP-211 doses against placebo. During the study, participants will undergo assessments including the Montgomery-sberg Depression Rating Scale MADRS at baseline, Day 2, and Day 28, along with other clinical evaluations such as the Clinical Global Impression-Severity CGI-S score. Researchers will track changes in depression symptoms, remission rates, and responses throughout the trial. Safety and tolerability will be monitored, and the study is expected to complete by September 2027.

ACP-211 Monotherapy for Major Depressive Disorder With Inadequate Antidepressant Response