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

Running, not enrolling · Phase 2

Conditions studied: Bipolar Disorder Depression

In brief

The goal of this clinical trial is to learn if ABX-002 added to participants' existing treatment(s) can improve clinical symptoms of depression and to learn about potential effects on brain chemistry that may correlate with antidepressive effects. This is a single treatment arm, open-label, Phase 2 study of ABX-002 in up to30 adults with bipolar depression. A subset of these participants will undergo brain imaging. Five healthy volunteer participants will also be enrolled and receive no drug treatment, undergoing 2 imaging sessions to confirm instrument and test - retest method reliability control. For bipolar disorder participants who are experiencing an episode of depression, the study will include 4 study periods: 1. Screening Period of up to 5 weeks 2. 6-week Treatment Period 3. 2-week post dose Safety Follow-up Period. 4. 6-month postdose targeted 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.

Key facts

Study ID
NCT06869187
Run by
Autobahn Therapeutics, Inc.
People needed
35
Starts
2025-03-28
Expected to finish
2026-09-24
Last updated by the study team
2026-05-26

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

Where it is running

Full record on ClinicalTrials.gov

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