Actively Recruiting
Study of ABX-002 for the Adjunctive Treatment of Depressive Episodes Associated With Bipolar Disorder in Adults
Led by Autobahn Therapeutics, Inc. · Updated on 2026-01-20
35
Participants Needed
15
Research Sites
50 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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: 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.
CONDITIONS
Official Title
Study of ABX-002 for the Adjunctive Treatment of Depressive Episodes Associated With Bipolar Disorder in Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 65 years
- Diagnosis of bipolar disorder for at least 2 years
- Current depressive episode lasting between 6 weeks and 24 months
- 17-item Hamilton Rating Scale for Depression score of 22 or higher at Screening and Baseline
- Young Mania Rating Scale score of 12 or lower at Screening and Baseline
- Able to undergo brain imaging if selected (no history of aborted scans due to anxiety, claustrophobia, or incompatible implants/devices)
- Taking at least one mood stabilizer or second-generation antipsychotic at a stable dose for 6 weeks or more before screening
- Healthy volunteers must be in good health with no significant medical or psychiatric conditions and able to undergo brain imaging
You will not qualify if you...
- History of more than 4 manic, hypomanic, or depressive episodes within one year in the last 2 years (rapid cycling)
- History of schizophrenia, schizoaffective disorder, or psychotic disorders unrelated to bipolar disorder
- Active or recent (within 2 years) obsessive-compulsive disorder or posttraumatic stress disorder
- Diagnosis of a personality disorder
- Evident risk of suicide at screening or baseline
- Inadequate response to more than 2 second-generation antipsychotics during current depressive episode
- Previous deep brain stimulation treatment or plans to receive it during the study
- Recent treatment (within 12 months) with electroconvulsive therapy, repetitive transcranial magnetic stimulation, ketamine, or esketamine
- New or changed psychotherapy within 6 weeks before screening
- Prior use of psychedelics for depression treatment
- Refusal to avoid excessive alcohol consumption during the study
- History of uncontrolled significant neurological, cardiovascular, gastrointestinal, respiratory, renal, hepatic, immunological, hematological, endocrine disorders, or cancer
- Use of high-dose benzodiazepines (>4 mg/day lorazepam equivalents)
- Use of cannabinoids in any form or frequency
- Eye conditions such as cataracts, glaucoma, inflammatory eye disease, or prior eye surgeries (including laser) in either eye
- Healthy volunteers excluded if mentally or legally incapacitated, have significant emotional problems, history of any illness, recent investigational drug/device use, prior psychedelic use within past year, refusal to avoid excessive alcohol, or cannabinoid use
AI-Screening
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Trial Site Locations
Total: 15 locations
1
Autobahn Site #213
Walnut Creek, California, United States, 94596
Actively Recruiting
2
Autobahn Site #201
Cromwell, Connecticut, United States, 06416
Actively Recruiting
3
Autobahn Site #210
Hartford, Connecticut, United States, 06106
Actively Recruiting
4
Autobahn Site #212
Miami, Florida, United States, 33014
Actively Recruiting
5
Autobahn Site #215
Chicago, Illinois, United States, 60622
Actively Recruiting
6
Autobahn Site #216
Worcester, Massachusetts, United States, 01608
Actively Recruiting
7
Autobahn Site #208
Cherry Hill, New Jersey, United States, 08002
Actively Recruiting
8
Autobahn Site #209
Hamilton, New Jersey, United States, 08690
Actively Recruiting
9
Autobahn Site #205
Marlton, New Jersey, United States, 08053
Actively Recruiting
10
Autobahn Site #203
Brooklyn, New York, United States, 11235
Actively Recruiting
11
Autobahn Site #207
New York, New York, United States, 10016
Actively Recruiting
12
Autobahn Site #211
New York, New York, United States, 10019
Actively Recruiting
13
Autobahn Site #202
New York, New York, United States, 10022
Withdrawn
14
Autobahn Site #204
Staten Island, New York, United States, 10314
Actively Recruiting
15
Autobahn Site #214
Bellevue, Washington, United States, 98007
Actively Recruiting
Research Team
R
Regina Griffin, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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