Phase 2 Study of ABX-002 Added to Antidepressants for Adults with Moderate to Severe Major Depressive Disorder

What this Trial Is About

Researchers are evaluating whether adding ABX-002 to an existing antidepressant treatment can improve depression symptoms in adults with moderate to severe major depressive disorder who have not adequately responded to their current antidepressant. This Phase 2, double-blind, placebo-controlled study aims to compare ABX-002 against a placebo alongside stable doses of selective serotonin reuptake inhibitors or serotonin norepinephrine reuptake inhibitors SSRISNRI. The study is sponsored by Autobahn Therapeutics, Inc. Participants will be randomly assigned to one of two groups one receiving ABX-002 oral solution and the other receiving a placebo, both taken as a 1-mL oral solution on an empty stomach each morning followed by water. All participants will continue their stable SSRI or SNRI antidepressant dose throughout the study. The study includes a screening period of about 35 days, a 42-day treatment period, a 2-week safety follow-up after dosing, and an additional 6-month targeted safety follow-up. During the study, participants will undergo assessments including the 17-item Hamilton Rating Scale for Depression HAMD-17 to measure changes in depression symptoms, as well as other scales like the Clinical Global Impression of Severity and Sheehan Disability Scale. Safety and tolerability will be monitored through adverse event reporting. The total participation time spans the screening through the extended safety follow-ups, with various evaluations conducted at specified intervals to track treatment effects and safety.

Study of ABX-002 for the Adjunctive Treatment of Major Depressive Disorder (AMPLIFY)