Florida Center for TMS
Clinical Studies
Evaluating Investigational Medication through Clinical Research
What is a Clinical Research Study?
A clinical trial, also called a clinical research study, is a carefully designed scientific evaluation of an investigational medication or treatment. Clinical trials are conducted by doctors and researchers.
What is Clinical Research Important?
Clinical research helps doctors and scientists determine if an investigational medication or therapies are safe and/or effective for use in humans to potentially treat a condition, disease, or disorder. Clinical studies often require many volunteers to participate in a single study, and sometimes thousands are needed to obtain reliable information.
What is Informed Consent?
“Informed Consent” is a process of information exchange before an adult agrees to participate in research. Potential research participants will be
asked to read and sign an informed consent document, but will also be
given instructions, verbally and in writing, question/answer sessions and other reading materials to ensure the potential study participant’s understanding and willingness to voluntarily enroll in the research.
Before you agree to volunteer for the study, the study doctor or staff is required to explain all the details of the study, which will include the risks and benefits, and address your questions. After all of your questions have been answered, and if you wish to participate, then you will sign a document called the informed consent form to ensure:
• You agree to volunteer.
• You understand the study, including the study procedures, risks, and potential side effects of the study medication.
• You understand that you can leave the study at any time, for any reason.
If you don’t understand what is expected of you or the document, you should continue to ask questions and talk with the study doctor, your family, or others that you trust, until you feel you understand.
Am I eligible?
You may be able to participate in this study if you:
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are 18-74 years of age
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have been diagnosed with depression
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have taken antidepressants in the past that did not work well for you
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are currently taking an antidepressant medication but still have symptoms of depression
Additional eligibility criteria will be assessed by the study doctor or staff during the screening process prior to you being enrolled in the study and receiving any investigational medication. Not all individuals may qualify to participate in the research.
Purpose of the Study
The purpose of this clinical research study is to determine the safety, efficacy, and maintenance of effect of an investigational medication. This investigational medication is being evaluated in people with depression.
What can I expect if I join the Study?
If you qualify and choose to join the study and sign the informed consent form, you will be asked to attend 2 screening visits with the study doctor. At these visits, you will undergo tests and procedures to determine if you are a good match for continuing in the study. The study will consist of 2 parts (Part 1 and Part 2). You will begin the study in Part 1.
- You will be in Part 1 for up to 10 weeks.
- In Part 1, you will be randomly assigned to receive the investigational medication or placebo once a day for 6 weeks.
- You will have an equal chance of receiving either study medication (the investigational medication or placebo).
- Placebo looks like the investigational medication but contains no active medication.
- Neither you nor the study team will know which study medication you are receiving.
- If you complete Part 1, you will have the option to continue the study in Part 2.
- In Part 2, everyone will receive the investigational medication for up to 16 weeks.
- If you continue in the study after 16 weeks, you may be randomly assigned to keep taking the investigational medication or receive placebo once a day for the remainder of the study.
• Just like in Part 1, you and the study team will not know which study medication you are receiving.
- Qualified patients may receive study-required medical care and investigational medication at no cost. The study will not pay for other medical care or current medication(s) needed to support your daily health care routine.
Let Us Help
Schedule Your Evaluation Today.
Contact Florida Center for TMS today to schedule your Evaluation at one of our three locations.
Let Us Help
Schedule Your Evaluation Today.
Contact Florida Center for TMS today to schedule your Evaluation at one of our three locations.
Let us help you today
Patient Testimonials.
“I can’t express enough how this TMS treatment has changed my life. The doctors and their staff literally have saved my life. This treatment has been the best treatment and care I have experienced in my life. I feel alive again”. – Renee
“After 30 years of depression and lack of motivation – I feel great! My wife and friends are amazed at the change. I now look forward to getting up and doing things to make each day special. The doctors and staff are very professional and caring.” – Ron
“Before my TMS treatment, I was struggling to move forward with my life. I spent all my time in my room. I just went to sleep. I suffered from depression for years. TMS has changed a lot of things. Today I start my day earlier, with sunshine in it.” – Sandra