Bipolar Disorder DepressionPhase 2NCT06869187
Study of ABX-002 for the Adjunctive Treatment of Depressive Episodes Associated With Bipolar Disorder in Adults
A Phase 2 study testing ABX-002 in people with Bipolar Disorder Depression, run by Autobahn Therapeutics, Inc. at 14 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bipolar Disorder Depression
- What is being tested?
- ABX-002
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 14 sitesUnited States
- Study dates
- 28 Mar 2025to 24 Sep 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- In good health, based on medical history, physical examination (including neurological examination), vital sign measurements, and laboratory safety tests obtained at the Screening Visit
- Able to undergo imaging sessions using Magnetic Resonance Spectroscopy/Imaging, with no history of aborted scanning due to anxiety, claustrophobia, or an incompatible implant/device
Who cannot join
- Mentally or legally incapacitated, has significant emotional problems at the time of the Screening Visit, or is expected to have potential for mental incapacitation during the conduct of the study
- History of any illness (including psychiatric illness)
- Participation in an investigational drug or device study where last dosing of previous drug is within 30 days
- Prior use of psychedelics within the past year
- Refusal to abstain from consumption of excessive amounts of alcohol during the study
- Cannabinoids (marijuana, cannabis, tetrahydrocannabinol [THC], cannabidiol [CBD]) in any form or use frequency are not allowed.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Autobahn Site #214
Bellevue, Washington, 98007
Autobahn Site #203
Brooklyn, New York, 11235
Autobahn Site #208
Cherry Hill, New Jersey, 08002
Autobahn Site #215
Chicago, Illinois, 60622
Autobahn Site #201
Cromwell, Connecticut, 06416
Autobahn Site #209
Hamilton, New Jersey, 08690
Autobahn Site #210
Hartford, Connecticut, 06106
Autobahn Site #205
Marlton, New Jersey, 08053
Autobahn Site #212
Miami, Florida, 33014
Autobahn Site #207
New York, New York, 10016
Autobahn Site #211
New York, New York, 10019
Autobahn Site #204
Staten Island, New York, 10314
Autobahn Site #213
Walnut Creek, California, 94596
Autobahn Site #216
Worcester, Massachusetts, 01608
About this study
Official title: A Phase 2 Open-label Study of the Effect of Adjunctively Administered ABX-002 in Adults With Bipolar Disorder Experiencing an Episode of Depression
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.
Read more
For bipolar disorder participants who are experiencing an episode of depression, the study will include 4 study periods:
- Screening Period of up to 5 weeks
- 6-week Treatment Period
- 2-week post dose Safety Follow-up Period.
- 6-month postdose targeted safety follow-up period
For healthy volunteers, the study will include 2 study periods:
- Screening Period of up to 3 weeks
- Imaging Period of up to 3 weeks.
- Conditions
- Bipolar Disorder Depression
- Being tested
- ABX-002
- Keywords
- BD Study, Adjunctive BD Study, Bipolar Depression, elunetirom
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABX-002Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 17-item Hamilton Depression Rating Scale (HAMD-17)
Utilizing 31P-Magnetic Resonance Spectroscopy (31P-MRS), a magnetic resonance imaging (MRI) method that measures high-energy phosphates in the brain
Measured: Week 6
Correlation of change from Baseline in the anterior cingulate cortex (ACC) phosphocreatine/inorganic (PCr/Pi) concentration with percentage change in 17-item Hamilton Depression Rating Scale (HAMD-17)
Utilizing 31P-Magnetic Resonance Spectroscopy (31P-MRS), a magnetic resonance imaging (MRI) method that measures high-energy phosphates in the brain
Measured: Week 6
Change from baseline for 29-item Hamilton Rating Scale for Depression (HAMD-29)
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.
Measured: Weeks 6
Change from baseline in 6-item Hamilton Rating Scale for Depression (HAMD-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.
Measured: Weeks 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start28 Mar 2025
- Primary completion22 Apr 2026
- Study completion24 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar Disorder DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Autobahn Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bridgette Franey, MD, Study director, Autobahn Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06869187
- Sponsor's protocol ID
- ABX-002-2002
- Status last verified
- May 2026
- First submitted
- 18 Feb 2025
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Open-label Study of the Effect of Adjunctively Administered ABX-002 in Adults With Bipolar Disorder Experiencing an Episode of Depression
- ClinicalTrials.gov ID
- NCT06869187
- Acronym / sponsor ID
- ABX-002-2002
- Conditions
- Bipolar Disorder Depression
- Keywords
- BD Study, Adjunctive BD Study, Bipolar Depression, elunetirom
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Autobahn Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Mar 2025 (actual)
- Primary completion
- 22 Apr 2026 (actual)
- Study completion
- 24 Sep 2026 (estimated)
- First posted
- 11 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Screening Period of up to 5 weeks
- 6-week Treatment Period
- 2-week post dose Safety Follow-up Period.
- 6-month postdose targeted safety follow-up period
For healthy volunteers, the study will include 2 study periods:
- Screening Period of up to 3 weeks
- Imaging Period of up to 3 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ABX-002 + at least one mood stabilizer and/or single second-generation antipsychotic (SGA) | Experimental | Drug: ABX-002Participants will continue all medications intended to treat the current episode of depression for the duration of the study in addition to 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) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- In good health, based on medical history, physical examination (including neurological examination), vital sign measurements, and laboratory safety tests obtained at the Screening Visit
- Able to undergo imaging sessions using Magnetic Resonance Spectroscopy/Imaging, with no history of aborted scanning due to anxiety, claustrophobia, or an incompatible implant/device
Key exclusion criteria (6 listed)
- Mentally or legally incapacitated, has significant emotional problems at the time of the Screening Visit, or is expected to have potential for mental incapacitation during the conduct of the study
- History of any illness (including psychiatric illness)
- Participation in an investigational drug or device study where last dosing of previous drug is within 30 days
- Prior use of psychedelics within the past year
- Refusal to abstain from consumption of excessive amounts of alcohol during the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABX-002ABX-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. | Drug | ABX-002 + at least one mood stabilizer and/or single second-generation antipsychotic (SGA) |
Primary outcome
Change from baseline for 17-item Hamilton Rating Scale for Depression (HAMD-17)
Time frame: Weeks 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.
4 secondary outcomes
Correlation of change from baseline in the anterior cingulate cortex (ACC) nucleoside triphosphate/inorganic phosphate (NTP/Pi) concentrations with percentage change in 17-item Hamilton Depression Rating Scale (HAMD-17)
Time frame: Week 6
Correlation of change from Baseline in the anterior cingulate cortex (ACC) phosphocreatine/inorganic (PCr/Pi) concentration with percentage change in 17-item Hamilton Depression Rating Scale (HAMD-17)
Time frame: Week 6
Change from baseline for 29-item Hamilton Rating Scale for Depression (HAMD-29)
Time frame: Weeks 6
Change from baseline in 6-item Hamilton Rating Scale for Depression (HAMD-6)
Time frame: Weeks 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bridgette Franey, MD study director
Autobahn Therapeutics, Inc.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ABX-002 in people with Bipolar Disorder Depression, run by Autobahn Therapeutics, Inc. at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline for 17-item Hamilton Rating Scale for Depression (HAMD-17) (time frame: Weeks 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.