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

Official 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

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: DOUBLE
• Enrollment: 230 participants

Interventions

• 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.

Primary Outcomes

• Change from Baseline in the 17-item Hamilton Rating Scale for Depression (HAMD-17) (6 weeks)

Secondary Outcomes

• Change from Baseline for Clinical Global Impression of Severity (CGI-S) (6 weeks)
• Change from Baseline for Sheehan Disability Scale (SDS) (6 weeks)
• Change from baseline for 6-item Hamilton Rating Scale for Depression (HAMD-6) (6 weeks)
• Change from baseline for 29-item Hamilton Rating Scale for Depression (HAMD-29) (6 weeks)
• Patient Global Impression-Improvement (PGI-I) (6 weeks)

Trial Locations

• Autobahn Site #131, Birmingham, Alabama, United States
• Autobahn Site #132, Chandler, Arizona, United States
• Autobahn Site #116, Phoenix, Arizona, United States
• Autobahn Site #136, Tucson, Arizona, United States
• Autobahn Site #150, Anaheim, California, United States
• Autobahn Site #113, Encino, California, United States
• Autobahn Site #133, Encino, California, United States
• Autobahn Site #124, Glendale, California, United States
• Autobahn Site #140, Long Beach, California, United States
• Autobahn Site #121, Los Alamitos, California, United States
• ...and 10 more locations

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