ABX-002 for Bipolar Depression
Trial Summary
Overview
This study is testing whether ABX-002 can help reduce symptoms of bipolar depression when added to your current medication. The drug is designed to activate thyroid hormone pathways in the brain, which may support brain energy activity and mood regulation.
What is the purpose of this trial?
The goal of this clinical trial is to learn whether a new investigational drug, ABX-002, can improve symptoms of bipolar depression when added to a person's existing mood stabilizer or anti-psychotic medication. This is a Phase 2, open-label study involving adults with bipolar disorder (I or II) who are currently experiencing a depressive episode and have not responded fully to their current treatment. The study includes three parts: Screening (up to 4 weeks), a 6-week treatment period with daily oral ABX-002, and a 2-week follow-up period.
Will I have to stop taking my current medications?
You will need to continue your current bipolar medications — such as a mood stabilizer or antipsychotic, and those medications must have been at a stable dose for at least 6 weeks before starting the study. However, you cannot take certain other medications during the trial, including drugs that affect liver enzymes (like some antibiotics or antifungals), biotin supplements, or substances like marijuana, psychedelics, or over-the-counter thyroid products.
What data supports the effectiveness of the drug ABX-002 for bipolar depression?
ABX-002 is an investigational drug known as a thyromimetic, meaning it mimics the effects of thyroid hormones, which are important for how the brain uses energy and regulates mood. It is designed to selectively activate thyroid hormone receptors in the brain, with the goal of improving symptoms of bipolar depression when added to standard medications like mood stabilizers or antipsychotics. In earlier studies, ABX-002 was generally well tolerated and showed signs of activity in brain regions linked to depression. This study is the first to explore its potential in people with bipolar disorder during a depressive episode.
Eligibility Criteria
Adults diagnosed with bipolar disorder (I or II) who are currently experiencing a depressive episode may be eligible for this study. To qualify, participants must be taking a mood stabilizer or antipsychotic medication, have had symptoms for at least 6 weeks, and meet other health and safety criteria. This is an open-label study, meaning all participants will receive the investigational drug ABX-002.Timeline
Screening
Participants are evaluated to confirm eligibility, including health history, current medications and a MRI scan
Treatment
Participants take ABX-002 once daily while continuing their current mood stabilizer or antipsychotic medication
Follow-up
Participants are monitored for safety and any changes in mood symptoms after stopping the study drug
Who Is Running the Clinical Trial?
Autobahn Therapeutics, Inc.
Lead Sponsor