Study of ABX-002 for the Adjunctive Treatment of Depressive Episodes Associated With Bipolar Disorder in Adults (NCT06869187)
A Phase 2 Open-label Study of the Effect of Adjunctively Administered ABX-002 in Adults With Bipolar Disorder Experiencing an Episode of Depression
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Autobahn Site #213 — Walnut Creek, California
Age range: 18 Years to 65 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (14 Sites)
- Autobahn Site #213 — Walnut Creek, California
- Autobahn Site #201 — Cromwell, Connecticut
- Autobahn Site #210 — Hartford, Connecticut
- Autobahn Site #212 — Miami, Florida
- Autobahn Site #215 — Chicago, Illinois
- Autobahn Site #216 — Worcester, Massachusetts
- Autobahn Site #208 — Cherry Hill, New Jersey
- Autobahn Site #209 — Hamilton, New Jersey
- Autobahn Site #205 — Marlton, New Jersey
- Autobahn Site #203 — Brooklyn, New York
- Autobahn Site #207 — New York, New York
- Autobahn Site #211 — New York, New York
- Autobahn Site #204 — Staten Island, New York
- Autobahn Site #214 — Bellevue, Washington
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
Explore by condition: All Bipolar Disorder Depression clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.