NCT06633016

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

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of ABX-002 for the Adjunctive Treatment of Major Depressive Disorder

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 230 (estimated)
• Sponsor: Autobahn Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	ABX-002	ABX-002 oral solution in 1-mL cyclic olefin polymer prefilled syringes, taken on an empty stomach first thing in the morning followed by 240 mL (8 oz) of water.
OTHER	Placebo	Comparator Placebo oral solution in 1-mL cyclic olefin polymer prefilled syringes, taken on an empty stomach first thing in the morning followed by 240 mL (8 oz) of water.

Timeline

• Start date: 2024-09-20
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2024-10-09
• Last updated: 2026-01-20

Locations

50 sites across 1 country: United States

Regulatory

• FDA-regulated drug study