Depressed so long it feels normal?

Frequently Asked Questions

Why is this research study being conducted?

The Landscape Depression Studies are evaluating an investigational oral medication to see if it reduces depression symptoms in women and men with major depressive disorder (MDD). The investigational oral medication is thought to target the brain in a new way and is being studied to understand its effects on depressive symptoms and symptoms of insomnia.

What can I expect if I participate?

The Landscape Depression Studies include a Screening Period, Treatment Period, and Follow-up Period.

Screening Period: The purpose of the Screening Period is to determine if you meet the requirements to take part in the study. You will go through a set of interviews at the study office, answer questions about your health and symptoms, and have some laboratory tests done. The study doctor will review all these results to determine your eligibility.

Treatment Period: If you qualify and decide to enroll in the study, you will take the assigned study medication at home on a daily basis. You will complete various questionnaires and tests to help the study doctor evaluate your health and symptoms.

Follow-up Period: After the Treatment Period, you will come back to the study office for follow-up visits.

If you pre-qualify and are referred to a research site, the study staff can provide you with more information.

Will I have to pay for anything if I choose to participate?

All study-related medical care and the assigned study medication will be provided at no cost. Transportation may be provided for those who require assistance.

Is my participation voluntary?

Yes, your participation in any research study is completely voluntary. If you decide to participate in a research study, you are always free to withdraw at any time for any reason without any penalty or effect on your future medical care.

Does my doctor need to give me permission to participate?

No, your doctor doesn’t have to give you permission to participate. But feel free to talk to your doctor about participating in the study. With your permission, the study doctor will keep your regular doctor updated about your condition during the study.

Will my personal information be kept private?

The information you provide will not be shared with anyone who is not directly associated with this research study without your permission (except as required by law) or as set forth in the informed consent.

What is a research study?

A research study, also called a clinical trial, evaluates the safety and effectiveness of an investigational medication to find out if it is better than, as good as, or no better than placebo. It is only through the completion of research studies that the investigational medication can be evaluated and, if proven safe and effective, approved for use for the condition that was studied. Research studies are performed according to government regulations that help protect the safety and rights of the participants.

What is an investigational oral medication?

An investigational oral medication is a study drug that is not approved for use or prescription by doctors for the condition being studied. Investigational oral medications are tested during research studies to see if they are safe and effective for a specific medical condition and/or group of people.

What are the risks of participating in a research study?

You could experience side effects associated with the investigational oral medication. There are also risks associated with some of the study procedures. The symptoms may not improve or may get worse during the research study. The doctor or study staff will discuss all of the possible risks and potential benefits in detail with you.

What is informed consent?

Informed consent is the process of learning the key facts about a research study before you decide to participate. It is also a continuing process throughout the study to provide information to participants. To help you decide whether or not to participate, the doctors and nurses involved in the research study will explain the details of the study. The study team will then provide you with an informed consent form to read. The document includes details about the study, such as its purpose, duration, and required procedures. Risks and potential benefits are also explained in the informed consent form. After you have received and read the information about the research study, you will then decide whether or not to sign the document. No study-related procedures can take place before you have signed the informed consent form. The informed consent form is not a contract, and you may withdraw from the research study at any time.

Who oversees research studies?

To help ensure that a clinical research study is ethical, and that participants’ rights are protected, Institutional Review Boards (IRB) or Ethics Committees (EC) review study protocols.

Who is sponsoring this study?

Sage Therapeutics, Inc. is sponsoring the Landscape Depression Studies.