1. Why should I participate in a clinical trial?   There are many diverse reasons for people to participate in clinical trials. You might want to be a part of advancing medical science. You might find there is an advantage for you since you will receive personalized physical examinations and specialized laboratory studies. You may have failed to get well using currently approved medications and want to try something else. You may be drawn to the possibility of receiving free medical treatment. Whatever the many different reasons people may have, the decision is yours alone and the reasons are yours alone as well.   2. What are the benefits of participating in a clinical trial?   You may be part of a study that discovers a new and more effective treatment for Major Depression. Such a discovery is only possible because of the participation of volunteers in clinical studies. You may receive help for your condition that you might not otherwise have received. You will receive careful medical examinations and laboratory tests all free of charge. It is not uncommon for us to diagnose a medical condition that a potential volunteer was completely unaware of. We stress the accuracy of precise diagnosis and quantitative measurement of the degree of depression. We also strive to rule out physical illness that can present as depression.   3. How much money will it cost me?   All of this is done at no cost to you. All medical care, medications, laboratory work and other medical tests are provided free of charge. Dr. Feiger provides four months of free follow-up care and one month of free medication after the study ends. AND you will be paid a small stipend for each visit to cover the costs of travel. This money is customarily disbursed at the termination of the study.   4. How long do studies last?   Again, that depends on the study. Some are as short as six weeks, some can go on for periods up to two years.   5. Is my participation in the clinical trial confidential?   When you sign up to be in a study, your initials will identify your file and a number assigned to your chart by the study protocol. However, there is a master record that links you to your records. This is done to insure that the FDA, the Biomedical Company, or the Institutional Review Board can contact you in the event that doing so is necessary for your safety. In rare cases other regulatory agencies may also have access to your records. However, insurance companies and the public are prohibited from seeing your records. Because you do not have to sign releases for an insurance company, your records are more confidential here than many of your records at a regular doctor’s office. See our Privacy Policy.   6. What happens if I become ill as a result of taking the medication?   The Biomedical Research Company will usually cover the costs of your care in excess of what your insurance would cover. This coverage varies from study to study, so make sure you clearly understand that specific information before you sign your informed consent form.   7. What if I want to keep taking the medication?   Because the medications in a study are investigational and haven’t been approved by the FDA, usually volunteers cannot continue the medication at the end of the study. However, you may be prescribed a medication by Dr. Feiger or you will be referred for appropriate follow-up treatment. We do not "drop" a volunteer and leave them to their own devices to obtain continuing care.   8. What are the dangers of participating in a clinical trial?   That depends on the trial. Every effort is made by the FDA, the Biomedical Company and the local IRB (Institutional Review Board) to insure your safety as much as possible. The various medications have already been through significant amounts of testing. Yet, to be truthful, sometimes problems with medications only become apparent during the trial itself. That is one of the reasons the trials are done. To insure your safety, you will come in for frequent visits and have regularly scheduled physical examinations and laboratory studies. If any significant problems crop up, you will be discontinued from the trial. Sometimes, the trial itself is halted. You are always to call the FHRC office any time you have a question. Safety cannot be guaranteed 100%, but every effort is made to minimize your risk.   9. How long does it take to get into a study?   Almost no time at all. Once you contact FHRC, you will be asked a number of questions about yourself to make sure you might qualify for the study. If you do, you will be seen in just a few days. See How to Participate in a Study.   10. Are the medications addicting?   Addiction to medications is characterized by (1) a craving for the medication, (2) a need for taking more and more medication to get the same response, and (3) significant, unpleasant, and even life-threatening symptoms if the medication is suddenly discontinued. Antidepressants don’t cause cravings and once the correct dose is achieved, more medication only results in more unpleasant side effects. In some cases, however, side effects can occur if an antidepressant is abruptly discontinued; so usually the dose is tapered when a person stops taking an antidepressant.   11. What are some of the restrictions I must observe if I volunteer for a clinical trial?   You will need to come in for frequent visits on a rather strict schedule. Many people find this inconvenient. You will not be allowed to use alcohol or any other mind-altering substance while in the trial. There are certain medications you cannot take while in a clinical trial. These will be listed for you when you are screened for the trial. You will not be allowed to take another antidepressant while you are in the trial. You will not be allowed to take most herbs and several forms of nutritional supplements while in the trial. Again, these will be covered at the screening visits. In some of the trials, you will not be allowed to participate in psychotherapy while participating in the study. Women must agree not to become pregnant during the trial. Either they are not to be sexually active or they must use an approved method of birth control.