Study of ABX-002 for the Adjunctive Treatment of Depressive Episodes Associated With Bipolar Depression in Adults

Study overview

The goal of this clinical trial is to learn if ABX-002 added to participants' existing treatment shows effects on brain chemistry that may relate to anti depressive effects This is a single treatment arm, open-label, Phase 2 study of ABX-002 in 30 adults with bipolar disorder and 5 healthy volunteers. Healthy volunteer participants will receive no drug treatment and will undergo 2 imaging sessions to confirm instrument and test - retest method reliability control. For bipolar disorder participants with depression, the study will include 3 study periods: 1. Screening Period of up to 4 weeks 2. 6-week Treatment Period 3. 2-week post dose Safety Follow-up Period. For healthy volunteers, the study will include 2 study periods: 1. Screening Period of up to 3 weeks 2. Imaging Period of up to 3 weeks.

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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Collaborators and Investigators

Autobahn Therapeutics, Inc.,

Study Record Dates

2026-03-13