I have heard or seen your ads, but I’m nervous about calling?

We understand your concern; but as some of our ads say, take that next step. 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-person evaluation. There is no cost to participate in a research study and no health insurance is required.

What will happen when I call about a research study?

You will speak to Jen Mellon, our Recruitment Coordinator, and she will ask you a few questions about why you are calling, any previous psychiatric diagnosis, your symptoms, your medical history, the medication you are taking, and any drug use. The call usually is about 10 to 15 minutes. After getting your basic information, we will let you know if there is a reason you would not be a good candidate for a research study.  For instance, uncontrolled high blood pressure or diabetes, a high body mass index (BMI), other significant medical history or ongoing use of street drugs will exclude you from most studies. If there is a chance you could be in a study, we would like to meet you in person and do an in-depth prescreening.  Jen will schedule you for a no cost prescreening and evaluation appointment.

Can you assist with transportation to our office?

We can assist with transportation via Uber/Lyft within a certain radius of our office. Please call for details.

What happens during the Prescreening and Evaluation appointment?

 First you will be asked questions to determine an exact diagnosis of your problem.  It is possible that Dr. Leon Rosenberg or Dr. Kristi Corcoran might clarify a diagnosis which before was unclear.  You do not necessarily have to know your diagnosis to qualify for a research study.  We will determine your diagnosis. A urine drug screen will also be done. 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. Please allow at least 30 to 45 minutes for the prescreening and evaluation.

What happens after the Prescreening and Evaluation?

 If after the prescreening and evaluation it is determined that you may be eligible 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 called the Screening Visit.

 If I come to the appointment and I am not eligible for a study, will I still get compensated?

 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. Compensation is provided by the study Sponsor for study subjects and eligibility for a study is set by the study Sponsor.

How long is the first study visit (Screening Visit)?

 Unfortunately, the Screening Visit can be very lengthy, anywhere from 3-4 hours.  First, you need to review and then sign the informed consent.  Then we will obtain your complete medical history , medication history, and perform several study specific psychiatric assessments. We will also get your vital signs, draw laboratory specimens, and do and electrocardiogram (ECG). The results of these procedures will let us know if you qualify to continue in the study. You will be compensated by check for the Screening Visit per the amount specified in the informed consent (usually at least $100 per visit).  

What determines if I qualify to continue in the research study?

 Every study has its own protocol which sets guidelines for who can be in the study and who cannot be in the study.  These are called the Inclusion and Exclusion criteria.  If after all the Screening Visit results are received, it is determined you meet the study’s guidelines for inclusion in the study (i.e. diagnosis, severity of illness) and do not meet any of the study’s reason for exclusions (i.e. drug use, high body mass index (BMI), abnormal labs or ECG), you would qualify to continue in the study.  Each study varies with the number of visits and length of the study.  Most double-blind studies on average are about 12 weeks and visits are usually weekly.  Some studies have an open-label extensions that can last 6 months to a year. Subsequent study visits can be anywhere from 2 to 3 hours. You will be compensated at each study visit per the amounts specified in the informed consent.

 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 submitted 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.

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 at any time for any reason. The informed consent document that you sign does not force you to remain in the study.

 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 medication. 

 What happens when the study is over?

Once you have completed a study, Dr. Leon 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.

Can I participate in a research study if I have participated in one or more in the past?

Most often the answer is yes, but there may be specific timelines.  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 time.