Depression Research Study Seeks Participants 60 Years Old and Up

Key Information:

The purpose of this survey is to determine whether you may be eligible to participate in a depression research study being run by Dr. Warren Taylor at Vanderbilt University Medical Center.

This study is enrolling adults aged 60 or older who are currently depressed or experiencing symptoms of depression. This study involves a clinical assessment, memory testing, brain scans, and study medication.

Before asking you questions and providing information about the study, we want you to know that you do not have to participate in this study to receive treatment for depression. There are many antidepressants that are commercially available and may be prescribed by your physician.

By participating in this study, you may be contributing valuable information that may benefit others in the future.

What will happen during this survey:

This survey will take approximately 10 minutes.

This survey is the first step to determine if you are a good fit for this study and if you may be eligible. We will ask you questions to see whether you may be eligible for the study. Final eligibility will not be determined until an in-person or virtual screening visit.

If you complete the survey and we determine you may be eligible for the study, a member of the study team will contact you. You will be asked to complete a screening visit. The study will be conducted at Vanderbilt University Medical Center.

Risks that you can expect if you take part in this survey:

If you decide to answer questions in this survey, there may be some potential risks.

First, your responses to these survey questions will be stored in a database managed by Trialfacts that can be accessed by research staff at Vanderbilt University Medical Center. We take your privacy very seriously and will make every possible effort, within reason, to ensure that your confidentiality will be protected. However, total confidentiality cannot be guaranteed. There is a risk that confidentiality could be breached. To keep your personal information confidential, we use a password-protected database and limit the number of team members who have access to that information.

Second, answering some of the questions might make you uncomfortable because they relate to your personal medical history. You do not have to answer these questions if you do not want, however, the system does not allow you to submit the form incomplete.

Risks of the study will be outlined in the consent form for the study at your first study visit.

Risks that are not known:

If you experience any unpleasant effects during this survey, please contact us.

Good effects that might result from this survey:

You may not benefit from this survey. However, if we find you may be eligible during this survey, we will contact you to discuss your eligibility and whether you would like to participate in the study.

Payment in case you are injured because of this research study:

If it is determined by Vanderbilt and the Investigator that an injury occurred as a direct result of the tests or treatments that are done for research, then you and/or your insurance will not have to pay for the cost of immediate medical care provided at Vanderbilt to treat the injury.

There are no plans for Vanderbilt to pay for any injury caused by the usual care you would normally receive for treating your illness or the costs of any additional care. There are no plans for Vanderbilt to give you money for the injury.

Who to call for any questions or in case you are injured:

If you have any questions about the research study, you can ask either a research coordinator or the study physician at (615) 936-8297. If you have any questions regarding research participants' rights you can contact the Vanderbilt IRB at (615) 322-2918 or toll-free at (866) 224-8273. If you feel you are injured as a result of this phone call, you can contact our lead study doctor, Dr. Warren Taylor at (615) 936-8297.

Costs to you for participating:

There is no cost to you for taking part in this survey.

What will happen if you decide to stop participating in this survey/study:

Your participation in this survey is voluntary. If you decide you do not want to participate, your regular medical care will not change in any way.

Privacy and Confidentiality:

Trialfacts is committed to protecting your privacy. The information collected will only be shared with the clinical research organization. For your reference, you may read more on the Trialfacts Privacy Policy.

Your information collected as part of this survey, even with identifiers removed, will not be used or distributed for future studies unless you agree to be contacted for future studies.

All reasonable efforts will be made to keep the personal information in your research record private and confidential, but absolute confidentiality cannot be guaranteed. Your information may be shared with institutional and/or governmental authorities, such as the Vanderbilt University Institutional Review Board, if you or someone else is in danger or if we are required to do so by law.

This study may have some support from the National Institutes of Health (NIH). If so, your study information is protected by a Certificate of Confidentiality. This Certificate allows us, in some cases, to refuse to give out your information even if requested using legal means.

It does not protect information that we have to report by law, such as child abuse or some infectious diseases. The Certificate does not prevent us from disclosing your information if we learn of possible harm to yourself or others, or if you need medical help.

Disclosures that you consent to in this document are not protected. This includes putting research data in the medical record or sharing research data for this study or future research. Disclosures that you make yourself are also not protected.

If you participate in this study, you will be given more information about the privacy and confidentiality measures of the study in the consent form at the screening visit.

Authorization to Use/Disclose Protected Health Information

What information is being collected, used, or shared?

When you sign up to participate in a clinical trial, Trialfacts will need to know your name, gender, contact number and email address, as well as the answers to some trial specific questions. This allows Trialfacts to determine your initial eligibility and pass your details on to study staff at Vanderbilt University Medical Center.

You may voluntarily sign up to Trialfacts’ mailing list to be notified about future trials as they are advertised on Trialfacts. For this service we need your basic eligibility criteria, to reduce the number of irrelevant emails sent to you, and your email address, which Trialfacts uses to send the information you requested.

Who will see, use or share the information?

Trialfacts does not sell, trade or rent your personal information to others, except for those parties clearly identified when you sign up for participation in a clinical study. Trialfacts may provide aggregate statistics about our customers, sales, traffic patterns, and related site information to reputable third-party vendors, but these statistics will include no personally identifying information.

The people who may request, receive or use your private health information include the Vanderbilt University Medical Center researchers and their staff. Additionally, they may share your information with other people at Vanderbilt, for example if needed for your clinical care or study oversight. By agreeing to complete this survey, you give permission to the research team to share your information with others outside of Vanderbilt University Medical Center. This may include the sponsor of the study and its agents or contractors, outside providers, study safety monitors, government agencies, other sites in the study, data managers and other agents and contractors used by the study team. We try to make sure that everyone who sees your information keeps it confidential, but we cannot guarantee that your information will not be shared with others. If your information is disclosed by your health care providers or the research team to others, federal and state confidentiality laws may no longer protect it.

How long will your information be used or shared?

Your Authorization for the collection, use, and sharing of your information does not expire. Additionally, you may agree that your information may be used for similar or related future research studies.

What if you change your mind?

You may change your mind and cancel this Authorization at any time. If you cancel, you must contact the Principal Investigator in writing to let them know by using the contact information provided in this consent form. You may also contact Trialfacts at [email protected] to have your information removed from their system. Your cancellation will not affect information already collected in the study, or information that has already been shared with others before you cancelled your authorization.

If you would like to find out if you might be eligible for this study, please complete the survey. Once we have reviewed your answers, you will be contacted by study team members from Vanderbilt University Medical Center if you may be eligible for the research study.

Are you willing to continue? *This question is required.