Depression FAQs
Depression
Q. Why are there no study sites in my area?
A. Study sites must meet strict criteria in order to be considered for participation in clinical research studies. Unfortunately, there are no participating study sites in your area.
Q. What type of care will I receive during this clinical research study?
A. If selected to participate, study staff conducts regular study-related physical and psychiatric examinations and laboratory tests while monitoring your health.
Q. Should I tell my doctor about this study?
A. If selected to participate in this clinical study, you should tell your doctor that you are volunteering for this clinical study. You should let your doctor know the duration of the study and the name of the doctor(s) at the study site. You can request that the study staff follow up with your doctor to explain your participation in the research study.
Q. Do I have my choice of doctors conducting this research study?
A. You may have the choice of selecting a study site during the prescreening process, but you will receive more information about the doctors participating in the study when you speak with study staff.
Q. What is a placebo?
A. A placebo is an inactive substance that looks like the study drug. The placebo group is often compared to a treatment group to determine how effective the study drug is for treating the intended condition.
Q. Is there a placebo in this study?
A. Yes. There is a fifty percent chance that you will receive either the active investigational medication or the placebo.
Q. If I begin the study and no longer want to participate, can I stop?
A. Yes. If at any time throughout the study you decide that you no longer want to participate, you have the option to discontinue. You will need to tell the doctor and/or study coordinator at the study site that you want to discontinue participation. You may be asked to make a final study visit for your own safety and to complete the study records.
Q. What is an Informed Consent Form?
A. The Informed Consent Form process allows you to receive all the information you need to decide for yourself whether or not you wish to participate in the study, should you qualify.
Q. Will it cost me anything to participate in the research study?
A. There is no monetary cost to the patient. If you are accepted to participate in this study, you will receive:
- Supervised medical care by health care professionals
- Investigational drug or placebo
- Study-related health monitoring and assessments
Q. How much will I be reimbursed for parking and transportation?
A. The study staff will discuss these details with you when you visit your clinical site.
Q. What are the risks of this investigational study drug/participating in a clinical research study?
A. As with all drugs, there can be foreseen and unforeseen side effects. The staff at the clinical study site will discuss this during the Informed Consent Process.
Q. I am concerned about confidentiality. Who will have access to my name and the information you are collecting?
A. All information for research purposes identifies you only by a code number. Please be assured that the study staff will hold your name and any information you provide in confidence.
Q. What is a clinical research study?
A. A clinical research study is a carefully controlled investigation of a medication’s safety and effectiveness. See " What are Clinical Trials ".
Q. What are the steps of a clinical research study?
A. Most clinical research that involves the testing of an investigational drug progresses in an orderly series of steps called phases. This allows researchers to ask and answer questions in a way that gathers reliable information about the drug and also protects participants.
Clinical studies are usually classified into 1 of 4 phases:
- Phase I Studies: These first studies in people evaluate how a new drug should be given (by mouth, injected into the blood, or injected into the muscle), how often, and what dose is safe. A phase I study usually enrolls only a small number of patients, sometimes as few as a dozen.
- Phase II Studies: A phase II study continues to test the safety of the drug and begins to evaluate how well the drug works. Phase II studies usually focus on a particular type of medical condition, such as depression.
- Phase III Studies: These studies test an investigational drug, a combination of drugs, or no treatment. A participant will usually be assigned to a treatment group at random (called randomization). Phase III studies often enroll large numbers of people and may be conducted at many doctors' offices and medical sites nationwide and worldwide.
- Phase IV Studies: Phase IV studies capture any additional information about how the drug should be used, and also identifies benefits and risks that have not been previously determined.
Sorce: the National Institutes of Health
Q. What is the phase of this clinical research study?
This clinical research study is a Phase II study.
Q. Why are there clinical research studies?
A. Clinical research studies exist to test the safety and effectiveness of new or existing drugs or procedures.
Q. Why should I participate in a clinical study?
A. By participating in a clinical trial, you are contributing to medical research that may help you and others. You are helping researchers answer questions about possible treatments that may one day be available to people in the US and possibly throughout the world.
Q. What is an investigational medication?
A. An investigational medication is a drug utilized in clinical research studies. This drug can be at various points in the process of receiving final FDA approval.
General Information Questions - Other study questions not previously listed
A. Once you have been referred to a study site in your area and are in contact with the study staff, you should feel free to ask any questions you may have about the study. The information you gain through this conversation will help you make an informed and comfortable decision about participation.
Q. What is the name of the investigational medication being studied?
A. This information is included in the Informed Consent Form and will be disclosed during the screening process at the study site.
Q. What is an adverse event?
A. An adverse event is any undesirable symptom or occurrence that a patient experiences during the clinical trial. It may or may not be considered related to the investigational medication.
Q. Why do I need to give you my zip code?
A. Your zip code will allow us to find the study site or sites closest to where you live and help you choose a location convenient for you. This way, you will be provided with the most up-to-date study location information for your area.
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