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NCT06869187 · ClinicalTrials.gov registry record · Phase 2
Study of ABX-002 for the Adjunctive Treatment of Depressive Episodes Associated With Bipolar Disorder in Adults
A Phase 2 study of Bipolar Disorder Depression, sponsored by Autobahn Therapeutics.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 35
- Enrollment target
- 15
- Study locations
NCT06869187 is a Phase 2 study of Bipolar Disorder Depression that is actively recruiting participants, run by Autobahn Therapeutics. The registered enrollment target is 35 participants. The trial reports 15 study locations across 8 states.
The verdict
NCT06869187, a Phase 2 study of Bipolar Disorder Depression, is actively recruiting participants, sponsored by Autobahn Therapeutics.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 35 participants
- Enrollment target
- 15
- Study locations
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 Studied
Interventions
- DRUG ABX-002
Study Locations (15)
New York
- Autobahn Site #203 - Brooklyn
- Autobahn Site #207 - New York
- Autobahn Site #211 - New York
- Autobahn Site #202 - New York
- Autobahn Site #204 - Staten Island
New Jersey
- Autobahn Site #208 - Cherry Hill
- Autobahn Site #209 - Hamilton
- Autobahn Site #205 - Marlton
Connecticut
- Autobahn Site #201 - Cromwell
- Autobahn Site #210 - Hartford
California
- Autobahn Site #213 - Walnut Creek
Florida
- Autobahn Site #212 - Miami
Illinois
- Autobahn Site #215 - Chicago
Massachusetts
- Autobahn Site #216 - Worcester
Washington
- Autobahn Site #214 - Bellevue
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2025-03-28 |
| Est. Completion | 2026-03-13 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06869187
The ClinicalTrials.gov registry entry for NCT06869187 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Autobahn Therapeutics, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Bipolar Disorder Depression appearing as the primary indexed condition, and to 1 intervention - of which ABX-002 is the first listed.
NCT06869187 reports 15 study locations spanning 8 distinct geographic areas - top geographies include New York, New Jersey, Connecticut.
Frequently Asked Questions
What is clinical trial NCT06869187 about?
NCT06869187 is a clinical study titled "Study of ABX-002 for the Adjunctive Treatment of Depressive Episodes Associated With Bipolar Disorder in Adults". 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...
What is the current status of trial NCT06869187?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 35 participants. The study started on 2025-03-28. Estimated completion is 2026-03-13.
What conditions does trial NCT06869187 study?
This clinical trial studies the following conditions: Bipolar Disorder Depression.
What interventions are being tested in trial NCT06869187?
The interventions under investigation include: ABX-002 (DRUG).
Who is sponsoring clinical trial NCT06869187?
This trial is sponsored by Autobahn Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06869187 being conducted?
This trial has 15 study locations across California, Connecticut, Florida, Illinois, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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