Are you interested in learning more about the CYPRESS post-traumatic stress disorder research study? You do not have to be diagnosed with PTSD to participate in the study as long as you:
- Have experienced or witnessed a traumatic event where you felt your life was in danger, saw someone die, suffered serious bodily injury or sexual violence, or experienced the sudden unexpected death of someone close to you within the past 9 years.
- Have unwanted memories of the event, struggle with fear and anxiety, feel isolated from family and friends; or avoid situations that remind you of the trauma and have had these symptoms for 6 or more months.
The CYPRESS study is evaluating an investigational medication, in combination with Sertraline, for the treatment of PTSD. Both Sertraline and the investigational medication in this study are approved for use in the United States. Sertraline is approved to treat depression and PTSD and the investigational medication is approved in combination with antidepressants for the treatment of major depressive disorder (MDD) and schizophrenia. Doctors believe the combination of the two medications could be a possible treatment option for PTSD in the future.
You may qualify for the CYPRESS study if you:
- Are 18 to 65 years of age.
- Have experienced or witnessed a traumatic event where you felt your life was in danger, saw someone die, suffered serious bodily injury or sexual violence, or experienced the sudden unexpected death of someone close to you within the past 9 years and were at least 16 years of age when it occurred.
- Have been experiencing symptoms associated with PTSD for at least 6 months prior to this study. PTSD symptoms can include unwanted memories of a traumatic event you experience or witnessed, struggling with fear and anxiety, feeling isolated from family and friends; or avoiding situations that remind you of the traumatic event.
You do not have to pay to be in this study and you will not be paid to participate. If you need to travel to the study doctor for your visits, the sponsor will reimburse reasonable costs for transportation.
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How do I participate?If you have experienced or witnessed a traumatic event within the past 9 years and now have unwanted memories of the event, struggle with fear and anxiety, feel isolated from family and friends; or avoid situations that remind you of the trauma, for 6 or more months, you may have Post-Traumatic Stress Disorder (PTSD). If you qualify to participate, and are interested, we will match you to a physician in your area conducting the CYPRESS study. The study team will then contact you and you may have the opportunity to participate if qualified.
If you think you would like to participate in the CYPRESS study and want to know more, please enter your information below. Keep in mind that participation is entirely voluntary. If you do decide to take part, you may change your mind about participating at any time.
About the CYPRESS study
The CYPRESS study will include approximately 2,600 volunteers and over 140 physicians located across the United States.
In this PTSD study, local doctors are evaluating an investigational medication in combination with Sertraline for the treatment of PTSD. Both Sertraline and the investigational medication in this study are approved for use in the United States. Sertraline is approved to treat depression and PTSD and the investigational medication is approved in combination with antidepressants for the treatment of major depressive disorder (MDD) and schizophrenia. Doctors believe the combination of the two medications could be a possible treatment option for PTSD in the future. Your participation in this study will make an important contribution to the development of treatments for PTSD.
Participants may receive all study-related visits, tests, and drugs from a dedicated medical team at no cost.
The study will include approximately 11 visits over approximately 17 weeks. COVID-19 has changed the way we live, work, and conduct clinical studies. If you have concerns about visiting a CYPRESS clinic research site (doctor’s office) relating to COVID-19 please inquire about alternative appointment opportunities.
Who can take part in the CYPRESS study?
You may qualify for the CYPRESS study if you:
- Are 18 to 65 years of age.
- Have experienced or witnessed a traumatic event where you felt your life was in danger, saw someone die, suffered serious bodily injury or sexual violence, or experienced the sudden unexpected death of someone close to you within the past 9 years.
- Have unwanted memories, flashbacks, struggle with fear, anxiety and isolation from loved ones, and avoid situations that remind you of the trauma.
All study-related care is provided by Specialist Physicians. In this study, researchers are evaluating an investigational medication in combination with Sertraline for the treatment of trauma related symptoms and PTSD.
We want to assure you that all of the CYPRESS clinical research sites have implemented COVID-19 cleaning and safety procedures and are happy to address any questions or concerns you may have. Your safety is our first concern!
- 1. Directly experienced or witnessed, in person, exposure to actual or threatened death, serious injury, or sexual violence.
- 2. Recurrent, involuntary, and intrusive distressing memories of the traumatic event(s).
- 3. Recurrent distressing dreams in which the content and/or effect of the dream are related to the traumatic event(s).
- 4. Flashbacks when confronted with familiar situations sometimes resulting in complete loss of awareness of present surroundings.
Frequently Asked Questions
What is a research study?
A research study (also called a clinical trial) is a medical study that helps to answer important questions about an investigational drug – these may include how well an investigational study drug works for a certain condition. All medications must be tested in clinical research studies before they can be approved and prescribed to patients.
What is the purpose of the CYPRESS study?
The CYPRESS study is evaluating an investigational medication in combination with Sertraline for the treatment of PTSD. Both Sertraline and the investigational medication in this study are approved for use in the United States. Sertraline is approved to treat depression and PTSD and the investigational medication is approved in combination with antidepressants for the treatment of major depressive disorder (MDD) and schizophrenia. Doctors believe the combination of the two medications could be a possible treatment option for PTSD in the future.
Pharmaceutical companies use research studies like this one to learn more about investigational drugs before they are made available to the public. The results of this study will provide more information about the potential benefits and side effects of this treatment regimen for people who experience unwanted memories of an event, struggle with fear and anxiety, and avoid situations that remind them of the traumatic event. By taking part in this study, you will be making an important contribution to PTSD treatment research.
What will the CYPRESS study involve?
The investigational drug (Brexpiprazole) was first approved in the United States in 2015 for the treatment of schizophrenia and as an add-on therapy for major depressive disorder (MDD). In this study, doctors want to evaluate the potential benefits of the investigational drug in combination with Sertraline (Zoloft) as a possible treatment for symptoms of fear and anxiety occurring due to unwanted memories of a traumatic event, often diagnosed as PTSD.
The results of this study will provide more information about the potential benefits of this treatment in reducing symptoms related to experiencing or witnessing a traumatic event.
What will happen during this study?
If you are eligible for this study, and you agree to participate, you could receive:
- The investigational drug and Sertraline, or
- The investigational drug and placebo, or
- Placebo only.
In addition to the trial medication, this PTSD study will also use placebo pills, which look like Sertraline and the other medication but contain no active medication. We use a placebo treatment to make sure that the medication under investigation is more effective than a pill with no active medication.
No matter which combination you receive, you will take your study drugs 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 can evaluate your health and progress through various tests and assessments.
If you qualify for the study and have concerns about attending study visits in person due to COVID-19 please inquire about alternate visit opportunities. The CYPRESS study can also arrange for a car service to take you to and from your appointments if requested at no cost to you.
**Extensive cleaning and sanitizing procedures are in place to ensure you remain safe during your complimentary ride to and from clinic appointments.
Total study participation will last approximately 17 weeks.
Please note that participation in this study is voluntary and you can stop participating at any time. Stopping your participation will not affect the medical care you receive, and it will not affect your relationship with your own doctor, study doctor or study staff.
Will I be reimbursed for travel?
Volunteers who qualify to take part in the study may receive reimbursement for travel. Your study team can also arrange for a car service to take you to and from your appointment if requested. Please discuss this with the study team when they contact you.
Is there a cost to participate?
There is no cost to participate in the CYPRESS study. If you qualify, all study-related visits, tests, and drugs may be provided at no cost. In addition, reimbursement for study-related travel may be provided. If you decide to take part:
- You will receive study-related care throughout the study from a team of experienced doctors and nurses.
- All study-related visits, tests, and drugs may be provided at no cost. In addition, reimbursement for study-related travel may be provided.
What else do you need to consider?
The research team will be able to explain more about what the CYPRESS study will involve, and it is up to you to decide if you want to take part. Participation in this study is voluntary. Whether or not you decide to participate in this study will not affect your current or future relationships with your doctors. If you decide to participate, you are free to withdraw at any time without affecting those relationships.
How far is the study clinic?
We match you to a study clinic within a close travel distance from your home. If we are not running the study in your area currently, with your permission, we will keep you in our database and reach out once a study in your area becomes available. If, at any time, you decide you no longer want your information stored, you can opt out and we will delete your details.
About Post-Traumatic Stress Disorder (PTSD)
Post-Traumatic Stress Disorder (PTSD) is a prevalent, debilitating, and often chronic neuropsychiatric illness (or mental health condition), that may develop in a person who has experienced, witnessed, or been confronted with an event or events that involve actual or threatened death or serious injury, or a threat to the physical integrity of oneself or others.
The majority of people who go through a traumatic experience have difficulty coping; however, with time, self-care, and therapy, the symptoms get better. For those who develop PTSD, these symptoms may never get better and often, get worse.1
PTSD can be categorized into four different groups:
- 1. Intrusive memories
- 2. Avoidance
- 3. Negative changes in thinking and mood
- 4. Changes in physical and emotional reactions
1. Intrusive memories symptoms
- Unwanted and distressing memories of the traumatic event
- Flashbacks
- Upsetting dreams and nightmares
- Severe emotional reactions to something that reminds you of the event
2. Avoidance symptoms
- Avoiding activities, people and places that bring back memories of the traumatic event
- Trying to avoid conversation about the traumatic event
3. Negative changes in thinking and mood symptoms
- Hopelessness
- Memory problems
- Negative thoughts
- Relationship difficulty
- Feelings of detachment
- Lack of interest
4. Changes in physical and emotional reactions
- Being on guard
- Easily startled or frightened
- Insomnia
- Difficulty concentrating
- Guilt or shame
- Destructive behavior
People who have experienced domestic violence, assault, or a traumatic event like a motor-vehicle accident, may experience PTSD.
People who have witnessed violence or a traumatic event may also experience PTSD.
There is also evidence that frontline workers such as police officers, hospital staff, army veterans, and first responders also have high rates of PTSD.2
No one knows better than you what it’s like to live with unwanted memories of a violent or traumatic event, to struggle with fear and anxiety, to avoid situations that remind you of the event or to feel isolated from family and friends. If you have had these symptoms for 6 months or more, you may have Post-Traumatic Stress Disorder, and we want to hear from you.
The CYPRESS study is evaluating the investigational drug in combination with Sertraline for the treatment of PTSD.