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

The goal of this clinical trial is to learn if ABX-002 added to an existing antidepressant treatment will benefit depression symptoms in adults with moderate to severe major depressive disorder who have had an inadequate response to their antidepressant. This is a double-blind, placebo-controlled, 2-arm, parallel-group, Phase 2 study, randomized 1:1 (ABX-002: placebo). The study will include the following stages: 1. Screening, approximately 35 days 2. 42-day Treatment Period 3. 2-week post dose Safety Follow-up Period 4. 6-month postdose targeted safety follow-up period

NCT Number	NCT06633016
Lead Sponsor	Autobahn Therapeutics, Inc.
Conditions	Major Depressive Disorder
Enrollment	230 participants
Start Date	2024-09-20
Primary Completion	2026-06 (estimated)
Study Completion	2026-06 (estimated)
Updated on ClinicalTrials.gov	2026-01-20