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

NCT06869187 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: ABX-002-2002
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 15

Brief 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. 1.Screening Period of up to 5 weeks
2. 2.6-week Treatment Period
3. 3.2-week post dose Safety Follow-up Period.
4. 4.6-month postdose targeted safety follow-up period
5. 5.Screening Period of up to 3 weeks
6. 6.Imaging Period of up to 3 weeks.

Conditions

Bipolar Disorder Depression

Outcome Measures

Primary Outcomes (1)

• Change from baseline for 17-item Hamilton Rating Scale for Depression (HAMD-17)

  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.

  Weeks 6

Secondary Outcomes (4)

• Correlation of change from baseline in the anterior cingulate cortex (ACC) nucleoside triphosphate/inorganic phosphate (NTP/Pi) concentrations with percentage change in Hamilton Depression Rating Scale (HAMD)-17

  Week 6

• Correlation of change from Baseline in the anterior cingulate cortex (ACC) phosphocreatine/inorganic (PCr/Pi) concentration with percentage change in Hamilton Depression Rating Scale (HAMD)-17

  Week 6

• Change from baseline for 29-item Hamilton Rating Scale for Depression (HAMD-29)

  Weeks 6

• Change from baseline in 6-item Hamilton Rating Scale for Depression (HAMD-6)

  Weeks 6

Study Arms (2)

ABX-002 + at least one mood stabilizer and/or single second-generation antipsychotic (SGA)

EXPERIMENTAL

Participants will continue all medications intended to treat the current episode of depression for the duration of the study in addition to ABX-002

Drug: ABX-002

No Treatment + Imaging Sessions

NO INTERVENTION

Healthy Volunteers will not receive any study treatment as their only assessment is 2 imaging sessions (baseline and retest)

Interventions

ABX-002 DRUG

ABX-002 oral solution in 1-mL cyclic olefin polymer prefilled syringes, taken on an empty stomach first thing in the morning followed by 240 mL (8 oz) of water.

ABX-002 + at least one mood stabilizer and/or single second-generation antipsychotic (SGA)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Current diagnosis of bipolar disorder for at least 2 years
• DSM-5-TR criteria for bipolar disorder based on Structured Clinical Interview for the DSM-5 - Clinical Trials Version (SCID-5-CT) at Screening
• Has a current depressive episode with or without mixed features, but not psychotic features, with duration ≥ 6 weeks and ≤ 24 months
• item Hamilton Rating Scale for Depression total score ≥ 22 at Screening and Baseline
• Young Mania Rating Scale total score ≤ 12 at Screening and Baseline
• For participants who will undergo brain imaging: Able to undergo imaging sessions using Magnetic Resonance Spectroscopy/Imaging with no history of aborted scanning due to anxiety, claustrophobia, or unable to scan due to an incompatible implant/device
• Taking at least one mood stabilizer (e.g., lithium, valproate, lamotrigine) and/or second-generation antipsychotic (SGA, atypical antipsychotic). All medications intended to treat the current episode of depression should be at an adequate and stable dose for ≥ 6 weeks prior to screening.

You may not qualify if:

• History of \> 4 manic, hypomanic, or depressive episodes within a one-year period (rapid cycler; DSM-5-TR) in the last 2 years
• History of schizophrenia or schizoaffective disorder (DSM-5-TR) or a psychotic disorder unrelated to bipolar disorder
• Concurrent or history of active symptoms within the past 2 years of obsessive-compulsive disorder, or posttraumatic stress disorder, according to DSM-5-TR criteria
• Diagnosis of a personality disorder (DSM-5-TR)
• Evident risk of suicide at Screening or Baseline
• Inadequate response to more than 2 second-generation antipsychotic treatments (including their current treatment) in their current episode of depression in bipolar disorder despite an adequate dose and duration (\> 6 weeks at approved or standard of care doses)
• Received any course of deep brain stimulation in participant's lifetime or plans to receive deep brain stimulation during the study
• Treatment with electroconvulsive therapy (for psychiatric/therapeutic purposes) or repetitive transcranial magnetic stimulation, or treatment with ketamine or esketamine for the current episode and received any of those treatments within 12 months prior to Screening
• Started new psychotherapy or had a change in the intensity of psychotherapy within 6 weeks before Screening
• Prior use of psychedelics for the treatment of depression
• Refusal to abstain from consumption of excessive amounts of alcohol during the study
• History of uncontrolled, clinically significant neurological (including prior cerebrovascular accident \[stroke\] or chronic seizures), cardiovascular, gastrointestinal, respiratory, renal, hepatic, immunological, hematological, endocrine (including uncontrolled diabetes), or other medical disorder, including cancer
• Current use of high dose (\> 4 mg/day lorazepam equivalents) benzodiazepine anxiolytic and/or hypnotic medication
• Cannabinoids (marijuana, cannabis, tetrahydrocannabinol \[THC\], cannabidiol \[CBD\]) in any form or use frequency.
• History or presence of cataract on ophthalmic examination (including slit-lamp), glaucoma, inflammatory eye disease prior ophthalmic surgical procedures or laser surgery in either eye.

Sponsors & Collaborators

• Autobahn Therapeutics, Inc.: lead

Study Sites (15)

Autobahn Site #213

Walnut Creek, California, 94596, United States

RECRUITING

Autobahn Site #201

Cromwell, Connecticut, 06416, United States

RECRUITING

Autobahn Site #210

Hartford, Connecticut, 06106, United States

RECRUITING

Autobahn Site #212

Miami, Florida, 33014, United States

RECRUITING

Autobahn Site #215

Chicago, Illinois, 60622, United States

RECRUITING

Autobahn Site #216

Worcester, Massachusetts, 01608, United States

RECRUITING

Autobahn Site #208

Cherry Hill, New Jersey, 08002, United States

RECRUITING

Autobahn Site #209

Hamilton, New Jersey, 08690, United States

RECRUITING

Autobahn Site #205

Marlton, New Jersey, 08053, United States

RECRUITING

Autobahn Site #203

Brooklyn, New York, 11235, United States

RECRUITING

Autobahn Site #207

New York, New York, 10016, United States

RECRUITING

Autobahn Site #211

New York, New York, 10019, United States

RECRUITING

Autobahn Site #202

New York, New York, 10022, United States

WITHDRAWN

Autobahn Site #204

Staten Island, New York, 10314, United States

RECRUITING

Autobahn Site #214

Bellevue, Washington, 98007, United States

RECRUITING

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Central Study Contacts

Regina Griffin, MS

CONTACT

8582573418; clinicaltrials@autobahntx.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2025
• First Posted: March 11, 2025
• Study Start: March 28, 2025
• Primary Completion: February 27, 2026
• Study Completion: March 13, 2026
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (15)