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

Autobahn Therapeutics

Status and phase

Enrolling

Phase 2

Conditions

Bipolar Disorder Depression

Treatments

Drug: ABX-002

Study type

Interventional

Funder types

Industry

Identifiers

NCT06869187

ABX-002-2002

Details and patient eligibility

About

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.

Enrollment

35 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria (For Bipolar Disorder Depression Patients):

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.

Exclusion Criteria (For Bipolar Disorder Depression Patients):

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.

Inclusion Criteria (For Healthy Volunteers):

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

Exclusion Criteria (Healthy Volunteers):

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.