FAQs: Research Studies & Clinical Trials: Many patients and families have questions about enrolling in research studies and clinical trials. Here are answers to some of the most frequent concerns.
FAQs: RESEARCH STUDIES & CLINICAL TRIALS
What is a research study?
In general, the purpose of a research study is to find an answer to a problem. These types of problems include how to pick the best treatment for a patient with an illness or how to better prevent someone from experiencing an illness.
A clinical trial is a specific type of research study. The purpose of a clinical trial is to decide whether or not a treatment should be approved for the general population. A clinical trial investigates the safety and effects of a wide range of medical treatments, from medication to surgical equipment and techniques.
Why participate in research studies?
Research evaluates how effective a new treatment of depression is compared to a standard therapy or a placebo (inactive) pill. Your participation can clearly help us understand more about depression and its treatments, participation in a research study can actually benefit the study participant directly.
Is it safe to participate in research studies?
Yes. To ensure your safety, doctors will follow your symptoms very closely during the course of the study. You will meet with a study doctor regularly (typically about once a week or once every other week). The doctor will ask you questions and may perform lab work (for example, blood draws or other physical examinations) to monitor your mental and general health. If the doctor is concerned about your safety, he or she may take you out of the study and help you find appropriate and care.
How often will I see a doctor?
Typically, patients see a doctor once every other week while participating in a study.
How soon can I come in for an appointment?
If you are eligible for an initial appointment after talking with a member of our research staff on the phone, we can often schedule your first appointment within 1 or 2 weeks.
Will you share information about me with anyone?
Your participation is confidential. We will not share information about you or your participation in a study with anyone (including insurance companies), unless you give us permission to do so, or if there is a medical emergency.
Can I participate in a study while I am on a waitlist to see a private psychiatrist?
Yes, you can participate in a study while you are on a waitlist to see a private psychiatrist.
What happens if I start the study and later decide that I don’t want to participate any more?
Your participation is voluntary. You may choose to withdraw from a study at any time, for any reason.
What is placebo? Why can't I find out if I was taking placebo?
Placebo is an inactive substance that is sometimes called a “sugar pill”. We compare the effects of placebo to the active medication and to make sure the results are not from visiting a doctor regularly, but are indeed effects of the active medication.
Research suggests that if you or your doctor were to know you were taking placebo, its potential benefits may change. Knowing what you are changing can alter your perception of whether or not you are getting better. For this reason, we don't reveal who was taking placebo until the very end of the study (sometimes up to 6 years).
What happens when I finish the research study?
We generally offer three months of free follow-up clinical care for anyone who has stopped or completed a study at our clinic. This means you can see a clinician about once a month after the study. The clinician will help you formulate a plan for continuing your psychiatric care after your leave our clinic.
I've been diagnosed with major (clinical) depression or I am experiencing what I think may be major depression, but I have also been diagnosed with another psychiatric condition. What studies do you have that would be appropriate for me?
Major depressive disorder is often accompanied by other disorders (either currently active or in the past), including anxiety, alcohol and drug use disorders, eating disorders, OCD, PTSD, ADHD. Studies generally allow for such patients to participate. In order to be sure, it’s best to check with the study doctors or coordinators beforehand.
I have not been diagnosed officially with major depression. Can you diagnose me over the phone with major depression when you screen me for one of your studies?
As part of our research screening process, we will ask you a variety of questions about your mental health and mood, including questions on the emotional and behavioral experiences that characterize major depression. We ask you these questions to make sure you would be a good fit for our research program and that one of our treatment studies would best fit your psychological needs.
However, your answers to these questions (and remember, there are no right and wrong answers) will not provide us with enough information to "officially" diagnose you with major depression. Making a diagnosis of major depression or any psychiatric diagnosis requires an in-depth clinical assessment with a licensed mental health professional who will be able to evaluate your depressive symptoms in the context of your general psychological and physical health and history.
Such a professional will be able to consider whether your overall psychiatric experience does indeed fit the criteria for major depression, or if there is a different diagnosis that ought to be considered over major depression, or in addition to major depression.
Am I going to see a therapist in your studies?
The kind of treatment you receive at the DCRP will depend on the particular study in which you participate. So, if you participate in a study looking at a talk therapy, then you will indeed meet with a psychiatrist or psychologist for psychotherapy sessions. However, you may also participate in a medication study without therapy sessions, in which case your appointments at the DCRP would be focused on your general progress and condition with the medication.
I am calling for a relative or friend who has major depression and would benefit from one of your treatment studies. If I describe this person's symptoms to you, can you tell me what kind of studies would be good for him/her or enroll him/her in one of your studies?
Before we enroll someone in one of our studies, we will need to directly speak with that person. But, if you give that person our number and s/he does call us, we would be more than happy to speak with him/her and see what options we might be able to offer.
Can my research doctor prescribe me other (non-psychiatric) medications?
Because our doctors only know you in a research setting and do not have access to your entire medical record, they will usually not prescribe you medications outside the confines of the study. However, at the conclusion of the study a three-month free follow-up period is offered to patients where, based on your symptoms, their clinical opinion and your treatment preferences, they may prescribe medications to alleviate depression, anxiety, or sleep troubles.
Presented by Depression Clinical & Research Program, Massachusetts General Hospital