NCT06869187Active, not recruitingPhase 2
Study of ABX-002 for the Adjunctive Treatment of Depressive Episodes Associated With Bipolar Disorder in Adults
A Phase 2 Open-label Study of the Effect of Adjunctively Administered ABX-002 in Adults With Bipolar Disorder Experiencing an Episode of Depression
Source: ClinicalTrials.gov · Last updated 26 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 35 (estimated)
- First submitted
- 18 Feb 2025
- Start date
- 28 Mar 2025
- Primary completion date
- 22 Apr 2026
- Lead sponsor
- Autobahn Therapeutics, Inc.
- Diseases
- Bipolar disorder
- NCT number
- NCT06869187
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 35
- From 28 Mar 2025 to the primary completion date, 22 Apr 2026
- 14 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- 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
- 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
- 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.
- 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
Other illness
- 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
- Diagnosis of a personality disorder (DSM-5-TR)
- 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)
- History of any illness (including psychiatric illness)
Other
- Evident risk of suicide at Screening or Baseline
- 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.
- 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
- 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.
Who the study is looking for
- 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
- 17-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.
- 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
Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (14)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.