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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
35
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.
Autobahn Site #213
Walnut Creek, California, United States
RECRUITINGAutobahn Site #201
Cromwell, Connecticut, United States
RECRUITINGAutobahn Site #210
Hartford, Connecticut, United States
RECRUITINGAutobahn Site #212
Miami, Florida, United States
RECRUITINGAutobahn Site #215
Chicago, Illinois, United States
RECRUITINGAutobahn Site #216
Worcester, Massachusetts, United States
RECRUITINGAutobahn Site #208
Cherry Hill, New Jersey, United States
RECRUITINGAutobahn Site #209
Hamilton, New Jersey, United States
RECRUITINGAutobahn Site #205
Marlton, New Jersey, United States
RECRUITINGAutobahn Site #203
Brooklyn, New York, United States
RECRUITING...and 5 more locations
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.
Time frame: Weeks 6
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
Utilizing 31P-Magnetic Resonance Spectroscopy (31P-MRS), a magnetic resonance imaging (MRI) method that measures high-energy phosphates in the brain
Time frame: 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
Utilizing 31P-Magnetic Resonance Spectroscopy (31P-MRS), a magnetic resonance imaging (MRI) method that measures high-energy phosphates in the brain
Time frame: 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.
Time frame: 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.
Time frame: Weeks 6
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