Our Clinical Trials
AMPLIFY-BD
Phase 2 Bipolar Depression Trial
Autobahn is currently conducting the AMPLIFY-BD study, a Phase 2 clinical trial of ABX-002 in patients with bipolar disorder experiencing a depressive episode who are getting insufficient relief from their treatment. The goal of this trial is to learn whether ABX-002 added to participants’ existing treatment shows effects on brain chemistry that may correlate to antidepressant effects, as well as evaluate the safety and tolerability of ABX-002 in patients with bipolar depression.
If you are suffering from bipolar depression and interested in participating in innovative research on a new investigational treatment option, we recommend you consult with your healthcare provider to learn more about our trial and potentially get involved.
AMPLIFY-BD Study Overview
Open-label Phase 2 study in adjunctive bipolar depression
Status
Treatment Period:
6 weeks
Post-Treatment Follow-up:
2 weeks
# of Study Visits:
Up to 6 visits
Who’s Included?
Adults 18-65
Study medication and Formulation:
ABX-002 oral solution
Possibility of placebo:
No
What is Bipolar Depression?
Bipolar depression refers to the periods of low mood, energy, and activity that are part of the mood cycling characteristic of bipolar disorder. These periods are distinct from mania or hypomania, the periods of elevated mood and energy. Bipolar depression can last for weeks or even months, and during these periods, individuals experience symptoms similar to those of major depressive disorder, such as:
- Persistent sadness or low mood
- Loss of interest or pleasure in most activities
- Fatigue or low energy
- Changes in sleep and appetite
- Difficulty concentrating
- Feelings of worthlessness or guilt
- Suicidal thoughts or behaviors
Bipolar depression affects nearly 7 million people in the United States and is distinct from major depressive disorder (also referred to as unipolar depression) because it occurs in the context of a broader illness that also includes episodes of elevated mood (mania or hypomania).
Treatment approaches for bipolar depression often differ from those for unipolar depression, as certain antidepressants can trigger manic episodes in people with bipolar disorder. Mood stabilizers and atypical antipsychotics are the most commonly used treatments for bipolar depression, whereas treatments common for MDD from the selective serotonin reuptake inhibitor (SSRI), serotonin-norepinephrine reuptake inhibitor (SNRI), and norepinephrine and dopamine reuptake inhibitor (NDRI) drug classes are typically used less frequently.
Despite the availability of numerous treatments, an unmet need exists in bipolar depression for more effective, better tolerated, and safer treatments that address the depression symptoms of bipolar disorder without risking cycling to manic symptoms. Addressing these gaps remains a major focus of ongoing scientific research and drug development.
Autobahn’s clinical research is focused on studying the biological and clinical effects of ABX-002 on top of participants’ existing treatment for bipolar depression.
Participants Must Be:
- Between the age of 18 and 65.
- Currently diagnosed with bipolar disease for at least 2 years.
- Experiencing a current episode of depression for at least 6 weeks and no longer than 2 years.
- Experiencing an inadequate response to a treatment for bipolar depression (e.g., mood stabilizer, second generation atypical antipsychotic, or SSRI/SNRI).
- Willing to continue on their existing treatment for the 6-week duration of the study.
- Willing and able to undergo Magnetic Resonance Imaging (MRI) twice during the study, with no history of aborted scanning due to anxiety, claustrophobia, or an incompatible implant/device.
Participants Must Not Have:
- A history of more than 4 manic, hypomanic, or depressive episodes within a one-year period in the last 2 years.
- Failed more than two single second-generation atypical antipsychotics, including the current treatment, during the current depressive episode.
- A history of schizophrenia or other psychotic disorders.
- A history of thyroid disease.
- A history of cardiovascular disease.
Additional inclusion/exclusion criteria apply. Participants will be evaluated at screening to ensure all criteria for study participation are met. Participants may be excluded from the study based on these assessments.
Frequently Asked Questions
The study plans to enroll approximately 30 patients diagnosed with bipolar depression.
The study is being conducted through clinical trial sites in the broader New York City area, with sites in New York, New Jersey, and Connecticut. The study also requires participants to make two visits to NYU Langone Health in New York City for certain assessments during the trial.
Study participants will be compensated for their time and travel while enrolled in the study.
If you believe you are a potential candidate for the AMPLIFY-BD study, please consult your healthcare provider to assess your eligibility and suitability for our clinical study. If you are ready to apply today, please visit the AMPLIFY-BD page on Power, where you will receive further information about the trial, pre-screening support, and help connecting you with a trial site close to where you live. For all other questions about the study and what to expect, please contact clinicaltrials@autobahntx.com for more information.