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

Phase 2

Recruiting

• Conditions: Bipolar Disorder Depression
• Interventions: Drug: ABX-002

• Registration Number: NCT06869187
• Lead Sponsor: Autobahn Therapeutics, Inc.

Brief Summary

The goal of this clinical trial is to learn if ABX-002 added to participants' existing treatment shows effects on brain chemistry that may relate to anti depressive effects

This is a single treatment arm, open-label, Phase 2 study of ABX-002 in 30 adults with bipolar disorder and 5 healthy volunteers. Healthy volunteer participants will receive no drug treatment and will undergo 2 imaging sessions to confirm instrument and test - retest method reliability control. For bipolar disorder participants with depression, the study will include 3 study periods:

1. Screening Period of up to 4 weeks

2. 6-week Treatment Period

3. 2-week post dose 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-18
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-04
• Study First Posted: 2025-03-25
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-26
• Study Start: 2025-04-01
• Primary Completion: 2026-02-27
• Study Completion: 2026-03-13

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ABX-002 + Mood Stabilizer (+/- antidepressant and/or single second-generation antipsychotic)	ABX-002	Patients will continue to receive their mood stabilizer, antidepressant and/or single second-generation antipsychotic, that they were on at study entry, at a stable dose for the duration of the study in addition to ABX-002.

Primary Outcome Measures

Name	Time	Method
Change from Baseline in the anterior cingulate cortex (ACC) nucleoside triphosphate/inorganic phosphate (NTP/Pi) concentration	Week 6	Utilizing 31P-Magnetic Resonance Spectroscopy (31P-MRS), a magnetic resonance imaging (MRI) method that measures high-energy phosphates in the brain
Change from Baseline in the anterior cingulate cortex (ACC) phosphocreatine/inorganic (PCr/Pi) concentration	Week 6	Utilizing 31P-Magnetic Resonance Spectroscopy (31P-MRS), a magnetic resonance imaging (MRI) method that measures high-energy phosphates in the brain
Percent change in Hamilton Depression Rating Scale (HAM-D)17	Week 6	The 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.
Methodological reliability control for 31P-MRS (Healthy Volunteer Only)	Week 6	Utilizing 31P-Magnetic Resonance Spectroscopy (31P-MRS), a magnetic resonance imaging (MRI) method that measures high-energy phosphates in the brain

Secondary Outcome Measures

Name	Time	Method
Change from baseline for 17-item Hamilton Rating Scale for Depression (HAMD-17)	Weeks 2, 4, 6	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.
Change from baseline for 6-item Hamilton Rating Scale for Depression (HAMD-6)	Weeks 2, 4, 6	Six-item scale used to assess the core symptoms of depression. HAMD-6 is a shorter version of HAMD-17. The higher the total score the more severe the depression.
Change from baseline for 29-item Hamilton Rating Scale for Depression (HAMD-29)	Weeks 2, 4, 6	HAMD-29 is a clinician-based assessment of depressive symptoms. Higher scores indicate worse symptoms. A score of 0-7 is generally accepted as not depressed, 8-16 indicates mild depression, 17-23 indicates moderate depression, and 24 and above indicates severe depression.

Trial Locations

Locations (6)

Autobahn Site #201; 🇺🇸 Cromwell, Connecticut, United States

Autobahn Site #208; 🇺🇸 Cherry Hill, New Jersey, United States

Autobahn Site #205; 🇺🇸 Marlton, New Jersey, United States

Autobahn Site #203; 🇺🇸 Brooklyn, New York, United States

Autobahn Site #202; 🇺🇸 New York, New York, United States

Autobahn Site #204; 🇺🇸 Staten Island, New York, United States