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While family and friends may try to understand what you’re going through, they don’t know the feelings of fear, isolation, and vulnerability that you experience from PTSD.
There are treatments available to you, but only about 60% of people with PTSD respond to these treatments. As a result, you could be one of many PTSD sufferers struggling with symptoms and feel like you’re facing PTSD alone.
One option available to you is this research study of an investigational drug for people diagnosed with PTSD. In this study, local doctors are evaluating the investigational drug as either a singular treatment for PTSD or as a combination treatment with Zoloft, an antidepressant that is approved in the United States for the treatment of PTSD. They will also compare the investigational drug to placebo, which looks like the investigational drug but contains no active medication.
The investigational drug, called brexpiprazole, is approved in the United States for treating major depressive disorder (MDD) and schizophrenia. Doctors believe it could be a possible treatment option for PTSD in the future.
The results of this study will provide more information about brexpiprazole and whether it could one day be an effective PTSD treatment.
Who is eligible to participate in this study?
To pre-qualify for this study, you must:
- Be 18 to 65 years of age
- Have had PTSD symptoms for at least 6 months prior to this study
- Have experienced your traumatic event after 2002 and when you were 16 years old or older.
All study-related visits, tests, and drugs will be provided at no cost. In addition, reimbursement for study-related travel may be provided.
What will happen during this study?
If you are eligible for this study, and you agree to participate, you will be randomly assigned (like the flip of a coin) to one of four study treatment groups:
- Brexpiprazole and placebo
- Zoloft and placebo
- Brexpiprazole and Zoloft
- Placebo only
As a study participant, you will have a 25% chance of being assigned to any one of these study treatment groups.
No matter which study group you are assigned to, you will take your study drug once a day for 12 weeks. You will also be asked to visit the study clinic up to 11 times so that doctors and study staff members evaluate your health and progress through various tests and assessments. Your total study participation will last approximately 14 weeks.
What are the risks and benefits related to this study?
As with any research study, you may not receive any medical benefit by participating in this study. The information collected during this study may help improve future treatments for PTSD.
It is also possible you could experience a side effect during this study. The study staff will review the full list of side effects with you before you join the study.
Additionally, your health and safety will be monitored closely while you are in this study. The sponsor of this study was required to design a protocol, which explains all study procedures in detail. An independent review board responsible for participant safety reviewed this protocol and requires that it be followed exactly.
If you are interested in joining this trial, click on the "Sign Up" button below to provide your contact information. One of our staff will be in touch with you within 24 hrs to conduct a short phone screen to determine your eligibility. Otherwise, you can call our center directly at (773) 275-3500 to speak with one of our staff today.