Invitation to be Part of a Research Survey

The purpose of this clinical research study is to understand how effective and safe an investigational study drug called lumateperone is and whether it works to reduce the severity of depressive symptoms in adults with Major Depressive Disorder (MDD) and early life trauma. You are invited to take part in a screening survey and phone call to see if you are eligible for this research study. If the survey indicates you may be eligible, you will be called by phone to confirm. Before you decide if you would like to participate, it is important for you to understand why the research is being done and what it will involve. Please take time to read the following information carefully. Feel free to ask if anything is not clear in this consent form.

Your Participation is Voluntary

It is totally up to you to decide to complete this screening survey and phone call (if applicable). Participating in this screening is voluntary. Even if you decide to be part of the screening now, you may change your mind and stop at any time. You do not have to answer any questions you do not want to answer. Your decision not to take part or to withdraw will involve no penalty or loss of benefits to which you are otherwise entitled.

What will happen if you take part?

The screening survey includes general questions about you, including demographic information, and questions about your mental and physical health. It will also include questions that may be considered sensitive, such as  history of childhood trauma, and willingness to partake in a medically accepted birth control method while in the study (if applicable). After the survey, you may be asked to provide your availability for a follow-up phone call. If you may be eligible to participate in our study, a research team member will contact you. Please note that you may not be contacted if you are not eligible to participate. If the study team contacts you by phone, they will ask you some personal questions about your health history, alcohol/drug use, history of assault exposure, your treatment for MDD, including medication use, and feelings and behaviors that may be impacted by your MDD. By completing this survey, you are consenting to provide the information below and for research staff to contact you about participating in this study. If you decide to participate in this research study, the researchers will ask you to schedule a phone call if eligible, in which a trained researcher will determine your eligibility for one or more of the studies. It will take approximately 15 minutes to complete the screening survey.

What risks and discomforts might you experience?

There are some risks and discomforts you might experience from participating in the screening survey and call. You may be uncomfortable while answering the questions. You can skip any questions that make you uncomfortable or that you do not want to answer. Participation in research might involve some loss of privacy. There is a risk that someone outside the research study could see and misuse information about you. More information about how we will protect your information to reduce this risk can be found below.

How could you benefit?

Participating in this screening is not likely to help you. If you are found to be eligible, the information you provide may help the investigators learn things that may help other people in the future.

How will information about you be protected?

OpenClinica/BuildClinical uses secure databases and systems to collect, store, and manage information submitted by prospective participants through study recruitment and prescreening activities. This information is accessible only to authorized individuals who need it to support recruitment, prescreening, study coordination, system support, or related oversight activities. 

Identifiable information collected through BuildClinical is not shared outside the authorized study team, OpenClinica/BuildClinical personnel supporting the service, or other authorized parties except as described in this consent, as necessary to operate the recruitment process, or as required by law. Results of recruitment or research activities may be reported in summary form, but identifiable personal information about participants will not be publicly disclosed. 

Personal information may be shared with or reviewed by authorized representatives of the following, as applicable, for purposes of conducting, managing, monitoring, supporting, or overseeing the study and related recruitment activities:

• the study sponsor, study site, or research staff
• OpenClinica/BuildClinical personnel and authorized service providers supporting the recruitment platform and related services
• Institutional Review Boards (IRBs) or Ethics Committees responsible for oversight of the study
• government, regulatory, or legal authorities, such as the Department of Health and Human Services or the U.S. Food and Drug Administration, when required

In certain situations, confidentiality may be limited. For example, information may be disclosed if required by law, regulation, court order, or where necessary to help prevent a serious and immediate threat to the health or safety of you or another person.

What will happen to the information we collect about you after the study is over?

The information you provide may be kept in the recruitment database even if you do not qualify for this study. It may be used to review your potential eligibility, contact you about this study, and, where allowed, support recruitment outreach for this study or other research opportunities that may be relevant to you. Your identifiable information will be stored securely and only accessed by authorized individuals who need it for recruitment, prescreening, study support, or oversight.

How will we compensate you?

You will not receive any type of payment for your participation.

Can you stop being in the study?

You can stop being in this research study at any time. Leaving the study will not affect your medical care, employment status, or academic standing at UT Austin or Dell Medical School. Tell the study staff if you are thinking about stopping or decide to stop.

If you withdraw from the study, data that has already been collected about you will remain part of the study database and may not be removed.

Contact Information for the Study Team

If you have any questions about this research, you can contact:

Dr. Julie Farrington Phone: 512-495-5566, 833-882-2737 (24 hours) Email: Julie.farrington@austin.utexas.edu

Or

Dr. Josh Cisler Phone: 512-495-5162 Email: josh.cisler@austin.utexas.edu

Contact Information for Questions about Your Rights as a Research Participant

If you have questions about your rights as a research participant, or wish to obtain information, ask questions, or discuss any concerns about this study with someone other than the researcher(s), please contact the following:

The University of Texas at Austin Institutional Review Board Phone: 512-232-1543 Email: irb@austin.utexas.edu

Please reference the protocol number found at the top of this document.