Step outside of your depression and look for options
Sadness, anxiety, fatigue — this seems to be what your life has become filled with. You’re avoiding seeing friends or loved ones and can’t remember the last time you looked forward to anything. You know you’re depressed, but don’t know what to do about it. Moderate-to-severe symptoms that last over a long period of time can cause significant health concerns.1
Depression is a serious medical condition that affects more than 264 million people worldwide.2
About the Study
The Aria Study is evaluating a study drug that may increase the activity of a chemical in the brain, which might help with symptoms of depression.
How do I qualify?
In order to participate, you must:
- Be 18-65 years old
- Have experienced episodes of depression* in the past
- Be currently experiencing an episode of depression that’s lasted between 8 weeks and 2 years
- Not be taking any antidepressant medication right now
If you qualify and decide to participate, you will receive:
- The study drug and all study-related care at no cost
- Close monitoring by an experienced study doctor and staff
- The opportunity to advance medical knowledge about depression
This section will help answer some important questions you may have
About The Aria Study
Why is this research study being conducted?
How does the study drug work?
The Aria Study is evaluating a study drug to see if it may reduce symptoms in people with moderate-to-severe depression.
How long does The Aria Study last?
The study drug may increase the activity of a chemical in the brain, that may help with symptoms of depression.
How do I decide if this study is right for me?
The study lasts about 8 weeks and includes about 8 visits to the study site and 2 telehealth visits (via video or phone).
Whom can I contact if I have more questions?
Before you agree to participate, the study team will review all aspects of the study with you, including required study assessments. If you decide to take part, you will be given a document called an Informed Consent Form that provides, in writing, the study’s purpose, assessments, procedures, benefits, risks, and precautions. You will have the opportunity to ask questions and decide if taking part is right for you.
What is a placebo?
If you are eligible to participate, the study doctor and research nurse or coordinator can provide more information and answer your questions.
A placebo is an inactive material that looks like the study drug but does not contain any active study drug. Researchers use a placebo to see if the study drug works better or is safer than taking nothing.
Privacy, Stopping Participation, Costs, and Permission
What happens to my personal information?
Can I withdraw from the study after I have started?
The study team respects and protects your privacy and will not share your information except as required by law and will store your personal information with codes that do not identify you. The Informed Consent Form will provide more information about how your privacy will be maintained.
Do I have to pay to participate?
Your participation in the research study is entirely voluntary and you may withdraw at any time. If you decide to withdraw early, you will be asked to notify the study team before doing so. You will be asked to return to the clinic at least once to complete a final visit and return any unused study drug.
Will I be paid for taking part/reimbursed for travel?
There is no charge for taking part. All assessments and study drug related to the research study are provided at no charge.
Does my doctor have to give permission?
You will not be paid for taking part in the study. The study team can inform you about reimbursement for expenses incurred to attend study visits if you are eligible.
Your doctor does not have to give permission for you to participate. However, either you or the study doctor, with your permission, may contact your personal doctor to discuss your participation before you begin and keep your doctor up to date about your progress.
About Research Studies
What is a research study?
Who oversees research studies?
A research study, also known as a trial, is a scientific study that evaluates the safety and effectiveness of a study drug. A research study may show that the study drug is better than, as good as, or worse than the standard treatment or inactive placebo (looks like the study drug but contains no active ingredient). Qualified doctors, nurses, and other medical professionals are responsible for conducting the study.
It is only through the completion of research studies that study drugs can be evaluated and, if proven safe and effective, approved for a particular use. Different regulatory bodies in different countries will provide this approval after a thorough review. Prescription medications in use today were first proven safe and effective during research studies.
Who can participate in a research study?
In order to ensure that a research study is ethical, and that participants’ rights are protected, Institutional Review Boards (IRB) or Ethics Committees (EC) review and approve study protocols that detail all aspects of how the study is conducted. In addition, study monitors, also known as clinical research associates, visit the study sites to confirm that the study protocol procedures and research study requirements and regulations are being followed throughout the study. Health authorities may also inspect the study sites to ensure the safety and rights of participants in a research study and the integrity of the research study objectives.
What is a study drug?
Only participants who meet all required eligibility criteria for a research study may take part. The study team at the clinic you select will review your medical history and current medical status against the eligibility criteria. They will determine if you are eligible to participate in the study. You may also be asked to provide information from your medical records to help the study team determine whether or not you may be eligible.
A study drug is a medication that has not been approved by regulatory or health authorities (eg, the US Food and Drug Administration [FDA] or the Australian Therapeutic Goods Administration [TGA]) for prescription use.