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

NCT06869187 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2026-01-20

No results posted yet for this study

Summary

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.

Conditions

  • Bipolar Disorder Depression

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.

Sponsors & Collaborators

  • Autobahn Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-03-28
Primary Completion
2026-02-27
Completion
2026-03-13
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06869187 on ClinicalTrials.gov