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RECRUITING Phase 2

Study of ABX-002 for the Adjunctive Treatment of Depressive Episodes Associated With Bipolar Disorder in Adults

NCT06869187 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 35 participants
Start Date 2025-03-28
Est. Completion 2026-03-13
Phase Phase 2

Sponsor

Autobahn Therapeutics

2 total trials

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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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06869187 reports 15 study locations spanning 8 distinct geographic areas — top geographies include New York, New Jersey, Connecticut. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06869187?

The interventions under investigation include: ABX-002 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06869187?

This trial is sponsored by Autobahn Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial