Study of ABX-002 for the Adjunctive Treatment of Depressive Episodes Associated With Bipolar Disorder in Adults
Public ClinicalTrials.gov record NCT06869187. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2 Open-label Study of the Effect of Adjunctively Administered ABX-002 in Adults With Bipolar Disorder Experiencing an Episode of Depression
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06869187
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 35 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 28, 2025 (Actual)
- Primary completion
- Apr 22, 2026 (Actual)
- Completion
- Sep 24, 2026 (Estimated)
- Last update posted
- May 26, 2026
2025 – 2026
United States locations
- U.S. sites
- 14
- U.S. states
- 8
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Autobahn Site #213 | Walnut Creek | California | 94596 | — |
| Autobahn Site #201 | Cromwell | Connecticut | 06416 | — |
| Autobahn Site #210 | Hartford | Connecticut | 06106 | — |
| Autobahn Site #212 | Miami | Florida | 33014 | — |
| Autobahn Site #215 | Chicago | Illinois | 60622 | — |
| Autobahn Site #216 | Worcester | Massachusetts | 01608 | — |
| Autobahn Site #208 | Cherry Hill | New Jersey | 08002 | — |
| Autobahn Site #209 | Hamilton | New Jersey | 08690 | — |
| Autobahn Site #205 | Marlton | New Jersey | 08053 | — |
| Autobahn Site #203 | Brooklyn | New York | 11235 | — |
| Autobahn Site #207 | New York | New York | 10016 | — |
| Autobahn Site #211 | New York | New York | 10019 | — |
| Autobahn Site #204 | Staten Island | New York | 10314 | — |
| Autobahn Site #214 | Bellevue | Washington | 98007 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06869187, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 26, 2026 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06869187 live on ClinicalTrials.gov.