Bipolar Disorder Depression
Conditions
Keywords
BD Study, Adjunctive BD Study, Bipolar Depression, elunetirom
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. 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.
Interventions
DRUGABX-002
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.
Sponsors
Autobahn Therapeutics, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline for 17-item Hamilton Rating Scale for Depression (HAMD-17) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | Week 6 | Utilizing 31P-Magnetic Resonance Spectroscopy (31P-MRS), a magnetic resonance imaging (MRI) method that measures high-energy phosphates in the brain |
| 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) | 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 for 29-item Hamilton Rating Scale for Depression (HAMD-29) | Weeks 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. |
| Change from baseline in 6-item Hamilton Rating Scale for Depression (HAMD-6) | Weeks 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. |
Countries
United States
Contacts
STUDY_DIRECTORBridgette Franey, MD
Autobahn Therapeutics, Inc.
Outcome results
None listed