Our Clinical Trials
AMPLIFY
Phase 2 MDD Trial
Do you or someone you love suffer from major depressive disorder?
Are you or your loved one taking an antidepressant and not getting enough relief from your symptoms?
Autobahn is currently conducting the AMPLIFY clinical trial to assess the efficacy and safety of ABX-002 as an adjunctive treatment for people with major depressive disorder. Our approach brings together a deep understanding of disease mechanisms, existing clinical research and practice patterns, and extensive experience running clinical trials to rigorously study our potential new treatment option for those suffering from MDD. You or a loved one might be a good fit for our AMPLIFY study and we invite you to learn more about our trial.
AMPLIFY Study Overview
Double-blind, placebo-controlled Phase 2 study in adjunctive major depressive disorder
Status
Treatment Period:
6 weeks
Post-Treatment Follow-up:
2 weeks
# of Study Visits:
Up to 9 visits
Who’s Included?
Adults 18-65
Study medication and Formulation:
ABX-002 oral solution
Possibility of placebo:
Yes
What is Major Depressive Disorder?
Major depressive disorder (MDD) is a serious and life-threatening mental health disorder in which people experience recurrent episodes of depression (known as major depressive episodes or MDEs) which may be several months to years in duration. MDEs are typically characterized by profound sadness and mood fluctuations, loss of pleasure or interest in activities, changes in appetite or weight, sleep disturbances, fatigue, feelings of worthlessness or guilt, hopelessness, and difficulty concentrating or making decisions.
MDD affects an estimated 21 million people in the United States and over 280 million people worldwide. MDD is one the leading causes of disability, greatly affects individuals’ ability to function in daily life, and is often associated with increases in suicidality.
Initial drug therapy for MDD typically consists of treatment with a single antidepressant from the selective serotonin reuptake inhibitor (SSRI) class. If patients either fail to respond to their initial treatment or experience intolerable side effects, they often switch to another SSRI, switch to a serotonin-norepinephrine reuptake inhibitor (SNRI) or norepinephrine and dopamine reuptake inhibitor (NDRI), or switch to adjunctive therapy – a treatment approach where a second antidepressant is added on top of a background SSRI or SNRI. The most commonly used adjunctive treatments today are atypical antipsychotics and NDRIs.
Despite the availability of numerous treatment options, many individuals with MDD struggle to achieve symptom relief that allows them to function in a normal and healthy state. Moreover, many individuals experience intolerable side effects from antidepressants, which can exacerbate the burden of the disorder and prolong a patient’s journey with MDD.
Autobahn’s clinical research is focused on studying the efficacy and safety of ABX-002 for the adjunctive treatment of MDD.
- Between the age of 18 and 65.
- Experiencing a moderate to severe episode of depression.
- Experiencing a current episode of depression for at least 6 weeks and no longer than 18 months.
- Experiencing an inadequate response to a single, adequate and stable dose of an SSRI or SNRI antidepressant.
- Willing to continue on treatment of their current SSRI or SNRI for the 6-week duration of the study.
- Failed more than two single SSRI or SNRI antidepressant treatments, 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 AMPLIFY study plans to enroll 230 participants diagnosed with moderate to severe MDD.
The AMPLIFY study is being conducted at clinical trials sites across the United States.
A placebo is a substance that looks like the investigational medicine but has no active ingredients. Some participants in the AMPLIFY study will be randomly selected to take a placebo instead of the investigational medicine. This is done to prevent bias and to understand if the investigational medicine is working.
The AMPLIFY study is a double-blind, placebo-controlled, randomized 1:1 (ABX-002:placebo) clinical study. Participants are assigned to their treatment group at random, meaning they will have a 50% chance of receiving either ABX-002 or placebo in the AMPLIFY study. Neither clinical trial participants nor their healthcare providers and study staff will know whether a participant receives study medication (ABX-002) or placebo.
Participants will be compensated for their time during the study.
If you believe you are a potential candidate for the AMPLIFY 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 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.