Clinical Research FAQs
What will happen when I call 866-DOC-LEON – Extension 22?
You will speak to Jen Mellon, our Recruitment Coordinator, and she will ask you a few questions about why you are calling, your medical history, the medication you are taking, and any drug use, and she will schedule you for a pre-screening appointment if you are an appropriate candidate for a research study.
How long is the first phone call?
The first phone call with Jen Mellon, our recruitment coordinator, is about 10-15 minutes long, but if you need more explanation, Jen is available and a great source of information.
Will you tell me on the phone if I do not qualify?
After getting your basic information, we will let you know on the first phone call if there is some reason you will not be a good candidate for one of our studies. For instance, ongoing use of street drugs or a significant medical history will exclude you from most studies. If there is a chance you could be in one of our studies, we would like to meet you in person.
Who is eligible to qualify for participation in a Research Study:
Every study sets its own guidelines for who can be in the study and who cannot be in the study. These are called the inclusion and exclusion criteria. If you meet the study’s guidelines for inclusion in the study (i.e. age, diagnosis, severity of illness), and do not meet any of the study’s reason for exclusions (i.e. drug use, significant medical issues), you will be eligible to enroll in a study.
Will my medical information remain confidential if I join a study?
As a participant in a research study, you will never be identified by name in any study documents, only subject ID numbers and initials are used. Although the FDA, Institutional Review Boards, and Sponsors may have access to the medical records of study participants. The informed consent for the study has a HIPPA form so all information is kept confidential.
How do I get into a Research Study?
After being seen in person, and it is determined that you are appropriate for a particular study, we will give you the informed consent document that relates to the study. This document describes in detail the purpose of the study, the design of the study, the risks of the study, the reimbursement you will receive for your participation in the study and the length of the study, etc. Prior to starting any study related procedures, the informed consent document is reviewed with you and then signed by you. You will have the opportunity to ask questions and have all your questions answered before you sign the document. Once you have signed the informed consent, we will conduct the first study visit.
Can I leave a Research Study? What do I need to do to stop being in a research study?
Your participation in a research study is totally voluntary. You are free to end your participation in one of our research studies at any time for any reason. The informed consent document that you sign does not force you to remain in the study.
What happens during the pre-screening and evaluation appointment?
First you will be asked questions to determine an exact diagnosis of your problem. It is possible that one of our two board certified psychiatrists, Dr. Jake Rosenberg or Dr. Leon Rosenberg might clarify a diagnosis which before was unclear. You do not have to know your diagnosis to qualify for a research study. We will determine your diagnosis. If you want to learn more about psychiatric diagnosis, feel free to download Dr. Leon Rosenberg’s book, the Authoritative Guide to Psychiatric Diagnosis, from this website.
If I come to the appointment and it is clear I do not qualify for a study and never signed an informed consent, will I still get compensated for time and travel?
No, but the medical evaluation is complimentary, and you will receive a written diagnosis to bring to your primary care physician, your psychologist, or your psychiatrist.
If I come to the appointment and I sign the informed consent document but during the screening process it is determined that I do not qualify for the study, will I get compensated for my time and travel?
Yes, you will get compensated for your time and travel according to the amounts specified in the informed consent, usually $75-$100 per visit.
If I sign the informed consent document, will I get compensated at the first appointment?
Yes, you will receive compensation at the end of the first study visit, called the “screening visit”, in the form of a check.
Is there a required drug test at the first appointment?
Yes, a urine collection for drugs of abuse is required.
Can you assist with transportation to your office?
We can assist with transportation within a certain radius of our office. Please call our office for details about Uber or Lyft.
How long is the first study visit appointment?
Unfortunately, the first study visit can be very lengthy, anywhere from 2-4 hours. First, you need to review and then sign the informed consent. Then we will obtain your medical history and perform several psychiatric assessments. We will also get your vital signs, draw laboratory specimens, and do and electrocardiogram (ECG). Please allot 2-3 hours for your second appointment and 1.5 hours for subsequent appointments.
Once I qualify, how many appointments will I need to commit to for the study?
Each study varies. Most double-blind studies on average are about 12 weeks. Some open-label extension studies can last 6 months to a year.
How much will I get paid?
Compensation amount is dependent on each individual study and their guidelines but is usually $75-$100 per visit.
Will I be required to take medication?
If there is a medication involved in the study you will be required to take the prescribed amount for the duration of the study. Most studies we conduct here are “double-blind” studies. That means that neither you or anyone on our study team know if you are taking active medication or the placebo. The placebo is a capsule or tablet that does not contain any active drug. Some studies are “open label” studies. In these studies, both you and we know that you are taking an active investigation medication.
What happens when the study is over?
Once you have completed a study, Dr. Leon Rosenberg or Dr. Jake Rosenberg will provide you with five no-cost follow-up appointments in the private practice of the Center for Emotional Fitness during which time arrangements will be made for you to be referred for treatment closer to home with a family doctor or psychiatrist or you have the option of paying for treatment at Center for Emotional Fitness.
Who are the doctors I will see for the study?
A: At almost every visit, you will see both Dr. Leon Rosenberg and Dr. Jake Rosenberg. Both doctors are board-certified psychiatrists.
Are there any female doctors?
Both psychiatrists in our practice are male, but the rest of the staff (eight other individuals) are all female.
If I have been previously diagnosed with a condition, should I tell you on the call?
Letting us know about a diagnosis and your symptoms will help us determine which studies might be best for you and whether or not you will qualify for one of our research studies.
I heard your commercial but I’m nervous about calling. I’m not sure if I should call you.
We understand your concern; but as some of our commercials say, take that first step today. If you decide to call us, it will not take more than 10-15 minutes of your time. Then you can decide how you want to proceed if we recommend an in-office evaluation.
Can you diagnose my condition over the phone?
The purpose of the initial phone call is to discuss general appropriateness for a study. We will be able to make a diagnosis when you come to the office for your pre-screening evaluation.
How do I know if I am depressed?
Being depressed and having a major depressive disorder are not exactly the same thing. Our board-certified psychiatrists, Dr. Jake Rosenberg and Dr. Leon Rosenberg are qualified to diagnose your symptoms.
Can I participate in a research study if I have participated in a research study in the past?
Most often the answer is yes. When you call our office, we will discuss the specifics of your previous research study. However, for your safety, you can never be in two research studies at the same.
Who will I meet at the first appointment?
You will meet Jen Mellon, our Recruitment Coordinator, with whom you spoke on the phone as well as other members of our staff, including Jin Jang, the Research Study Coordinator, and Elisabel Albizu, the Laboratory Coordinator. You will also meet with both Dr. Jake Rosenberg and Dr. Leon Rosenberg.
If I qualify, will I get a placebo or an active drug?
Most research studies are double-blind randomized studies meaning that participants are randomly assigned to one treatment or the other. There are some studies that are open-label meaning that participants receive active investigational drug.
Do I have to pay to be a part of this study?
No, our studies are free to participants who qualify.
Do I need health insurance to participate?
No, the cost of the study and medication are covered by the study. Your insurance company is not notified or billed about your participation in a study.
If I don’t qualify, do I have to pay for the first appointment?
No, the visit is complimentary, and you will receive a written diagnosis to take to your primary care physician, psychologist, or your psychiatrist.
Do you have Covid-19 precautions in place?
Yes, we have safety procedures in place for patients and staff. All patients will be required go through a series of Covid-19 pre-screening questions and a temperature check. Masks are required. Social distancing protocols are in place at the office. We consider your safety and ours of utmost importance. Each of our evaluation offices is divided in half and a floor to ceiling glass wall separates you from our team and us from you. We wear masks at all times in the office and require you to do this as well. Meeting new doctors can often produce anxiety. We wanted to make sure that you feel 100% safe here and we feel we have accomplished this goal with the measures we have put I place.