Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting Phase 2 study of Bipolar Disorder Depression, sponsored by Autobahn Therapeutics.
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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower). The trial reports 15 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
HAMD-17 is a clinician-based assessment of depressive symptoms. Higher scores indicate worse symptoms. A score of 0-9 is generally accepted to be within the normal range (or in clinical remission), while a score of greater than 17 indicates moderate to severe depression symptoms.
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 |
What NCT06869187 shows while recruiting
NCT06869187 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower).
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 lists 15 locations in 8 states (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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06869187's enrollment target sits among peer trials
35 1524th of 2000 higher than 462 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01697371 · 35 participants · NA
Proton Therapy in the Treatment of Liver Metastases
- NCT01940757 · 35 participants · Phase 1
Experimental Infection of Hookworm-naïve Adults With Dermally-applied Infectious Necator Americanus Hookworm Larvae
- NCT02235857 · 35 participants · NA
Post Approval Study of Liposorber LA-15 System for the Treatment of Focal Segmental Glomerulosclerosis in Children
- NCT02637934 · 35 participants · Phase 1
Phase I Pilot Study of Biodistribution, Metabolism and Excretion of Novel Radiotracer [18F]Fluorthanatrace (FTT) by PET/CT
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI