Study of ABX-002 for the Adjunctive Treatment of Depressive Episodes Associated With Bipolar Disorder in Adults
- Registration Number
- NCT06869187
- Lead Sponsor
- Autobahn Therapeutics, Inc.
- Brief Summary
The goal of this clinical trial is to learn if ABX-002 added to participants' existing treatment(s) shows 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 30 adults with bipolar depression. 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 3 study periods:
1. Screening Period of up to 4 weeks
2. 6-week Treatment Period
3. 2-week post dose 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 35
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ABX-002 + at least one mood stabilizer and/or single second-generation antipsychotic (SGA) ABX-002 Participants will continue all medications intended to treat the current episode of depression for the duration of the study in addition to ABX-002
- Primary Outcome Measures
Name Time Method 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 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) nucleoside triphosphate/inorganic phosphate (NTP/Pi) concentrations with percentage change in 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
- Secondary Outcome Measures
Name Time Method 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.
Change from baseline for 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.
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.
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Trial Locations
- Locations (6)
Autobahn Site #201
🇺🇸Cromwell, Connecticut, United States
Autobahn Site #208
🇺🇸Cherry Hill, New Jersey, United States
Autobahn Site #205
🇺🇸Marlton, New Jersey, United States
Autobahn Site #203
🇺🇸Brooklyn, New York, United States
Autobahn Site #202
🇺🇸New York, New York, United States
Autobahn Site #204
🇺🇸Staten Island, New York, United States
Autobahn Site #201🇺🇸Cromwell, Connecticut, United States