RecruitingPhase 2NCT06869187

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

A Phase 2 Open-label Study of the Effect of Adjunctively Administered ABX-002 in Adults With Bipolar Disorder Experiencing an Episode of Depression


Sponsor

Autobahn Therapeutics, Inc.

Enrollment

35 participants

Start Date

Mar 28, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called ABX-002 as an add-on treatment for adults with bipolar disorder who are currently experiencing a depressive episode (a period of persistent low mood, not a manic episode). **You may be eligible if...** - You are an adult diagnosed with bipolar disorder for at least 2 years - You are currently in a depressive episode that has lasted at least 6 weeks but no more than 2 years - Your depression is rated as moderate to severe on standard scales - You are already taking at least one mood stabilizer or antipsychotic medication at a stable dose for at least 6 weeks - You do not currently have psychotic symptoms (such as hallucinations) **You may NOT be eligible if...** - You have had more than 4 manic episodes - You are not currently in a depressive episode - You are not taking a mood-stabilizing medication - You have certain metal implants that prevent MRI scans (if brain imaging is part of your participation) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGABX-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.


Locations(15)

Autobahn Site #213

Walnut Creek, California, United States

Autobahn Site #201

Cromwell, Connecticut, United States

Autobahn Site #210

Hartford, Connecticut, United States

Autobahn Site #212

Miami, Florida, United States

Autobahn Site #215

Chicago, Illinois, United States

Autobahn Site #216

Worcester, Massachusetts, United States

Autobahn Site #208

Cherry Hill, New Jersey, United States

Autobahn Site #209

Hamilton, New Jersey, United States

Autobahn Site #205

Marlton, New Jersey, United States

Autobahn Site #203

Brooklyn, New York, United States

Autobahn Site #207

New York, New York, United States

Autobahn Site #211

New York, New York, United States

Autobahn Site #202

New York, New York, United States

Autobahn Site #204

Staten Island, New York, United States

Autobahn Site #214

Bellevue, Washington, United States

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NCT06869187


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