Are you living with posttraumatic stress disorder (PTSD)?

Consider taking part in the Monarch Study, which is evaluating how effective a study drug is in treating the symptoms of PTSD.

You may be eligible to participate in the Monarch Study if you:

  • Are between the ages of 18 and 70 years old
  • Have been diagnosed with posttraumatic stress disorder (PTSD)

Learn more about the Monarch Study

Watch this informative video to hear stories shared by people living with PTSD and to learn more about the Monarch Study from Dr. Kimberly Babson, who explains what the study drug is and provides important details about the study that people living with PTSD will need to consider before participating.

To find out if you may be eligible for the Monarch Study, contact a study site location near you.

About the Monarch Study

The Monarch study will evaluate how effective a study drug is in treating the symptoms of PTSD when given in different doses compared to a placebo, which looks like the study drug but does not have any active ingredients. The results from this study will be used to develop future studies for PTSD.

This study is being conducted in study sites across the U.S. and will enroll 270 adults aged 18 to 70 who have been diagnosed with PTSD.

Participation in the study will last up to 18 weeks, which includes a screening period (up to 4 weeks), a 12-week treatment period, and a 2-week follow-up period. During this participation period, you will make 7 clinic visits and have 3 phone calls with the study doctor.

Those who are eligible and choose to participate in the study will receive the study drug or placebo, as well as study-related visits, tests and assessments, at no cost. Participants may also be reimbursed for some study-related expenses.

Is the Monarch Study right for me?

You may be eligible to participate in the Monarch Study if you:

  • Are between the ages of 18 and 70
  • Have been diagnosed with posttraumatic stress disorder (PTSD)

If you are interested in participating in the Monarch Study and want to find out if you may qualify, contact a study site location near you.

About Posttraumatic Stress Disorder (PTSD)

PTSD is a common condition that can develop after a person has experienced or witnessed a shocking or traumatic event. About 7% of all people have PTSD at some point in their lifetime. PTSD can look very different across individuals. They often experience nightmares and really strong emotional and physical effects when confronted with reminders of that traumatic event. In some cases, PTSD can affect a person’s relationships and their ability to function at home and work.1

Despite the significant impact on patient’s lives, there is no cure available for this condition, and not everyone responds to medications approved to treat PTSD. Only two antidepressants have received approval from FDA for the treatment of PTSD symptoms in the past 20 years.2-4 And there are currently no approved therapies that target the underlying biology in the brain that transforms traumatic events and experiences into the chronic mental health illness of PTSD.

The Monarch Study is evaluating how effective a study drug is in treating the symptoms of PTSD, with the goal of developing a new treatment option to help those individuals out there who are struggling with PTSD.

PTSD is a common condition that can develop after a person has experienced or witnessed a shocking or traumatic event. About 7% of all people have PTSD at some point in their lifetime. PTSD can look very different across individuals. They often experience nightmares and really strong emotional and physical effects when confronted with reminders of that traumatic event. In some cases, PTSD can affect a person’s relationships and their ability to function at home and work.

Despite the significant impact on patient’s lives, there is no cure available for this condition, and not everyone responds to medications approved to treat PTSD. Only two antidepressants have received approval from FDA for the treatment of PTSD symptoms in the past 20 years.2-4 And there are currently no approved therapies that target the underlying biology in the brain that transforms traumatic events and experiences into the chronic mental health illness of PTSD.

The Monarch Study is evaluating how effective a study drug is in treating the symptoms of PTSD, with the goal of developing a new treatment option to help those individuals out there who are struggling with PTSD.

References:

  1. DSM-5 Criteria for PTSD. American Psychiatric Association (APA). Diagnostic and Statistical Manual for Mental Disorders. 5th ed. Arlington, VA: American Psychiatric Publishing; 2013.
  2. Ehret M. Treatment of posttraumatic stress disorder: Focus on pharmacotherapy. Ment Health Clin. 2019;9(6):373-382. Published 2019 Nov 27. doi:10.9740/mhc.2019.11.373
  3. Zoloft® (sertraline hydrochloride) tablets, for oral use. US Prescribing Information. Roerig, New York, NY, US. December 2016.
  4. Paxil® CR (paroxetine) extended-release tablets, for oral use. US Prescribing Information. GlaxoSmithKline, Research Triangle Park, NC, US. September 2019.

Frequently Asked Questions

What is a study?

A study (also called a clinical trial) is a medical study that helps to answer important questions about an investigational medication—these may include how well an investigational medication works for a certain condition. All medications must be tested in clinical research studies before they can be approved and prescribed to patients.

Why are studies important?

A study is the process by which new and innovative medications, interventions, and treatments are approved and brought to the general public, so people can hopefully live happier and healthier lives. Even over-the-counter medications, such as aspirin that you may have used to counteract a headache, have gone through the clinical research study process before they were available at your local pharmacy.

What is the purpose of the Monarch Study?

The Monarch Study will evaluate how effective a study drug is in treating the symptoms of PTSD when given in different doses compared to a placebo. The results from this study will be used to develop future studies for PTSD.

What will the Monarch Study involve?

The total duration of the study for each participant will be approximately 18 weeks. During the screening period, which will occur over a period of up to 28 days, the study doctor will ask participants some questions and do some tests to see if they are eligible for the study. Participants will also be asked to stop taking any medications that are not allowed in the study.

If qualified, participants will be randomly assigned, like drawing straws, to one of three treatment groups to take either one of two doses of the study drug or a placebo. A placebo is a tablet that looks like the study drug but contains no active ingredients. This study is double-blind, which means that neither participants nor the study doctor will know which treatment they are taking during the study. Participants will have a clinic visit and be given a supply of study drug to take home.

The treatment period will take 12 weeks to complete and includes 4 clinic visits (up to 4 hours each visit) and 3 phone calls with the study doctor. During this period of the study, participants will take their study treatment once a day at home as instructed by the study doctor.

A safety follow-up visit will occur 2-weeks after the treatment period is completed. During this period of the study, participants will have a visit at the clinic for some tests and procedures.

Will I be compensated for time and travel?

Volunteers who qualify to take part in the study may receive reimbursement for time and travel. Please discuss this with the study team.

Is there a cost to participate?

There is no cost to participate in the Monarch Study. If you are eligible and decide to take part:

  • You will receive study-related care from a team of experienced doctors and nurses throughout the study
  • All study-related visits, tests, assessments, and investigational medication will be provided at no cost to you
What else do I need to consider?

The research team will be able to explain more about what the Monarch Study will involve, and it is up to you to decide if you want to take part. Participation in this study is voluntary. Your decision to participate or not participate will have no effect on the medical care you receive now or in the future. If you are eligible and choose to participate in the Monarch Study, you may leave the study at any time without providing any reason.

Where are the study sites located?

If you are interested in participating in the Monarch Study and to find out if you may qualify, contact a study site location near you.

The Monarch Study Is Taking Place Now

Contact the site closest to you to learn if you are eligible

There are Monarch Study sites located throughout the United States. View the study sites by location to determine which is closest to you. Contact a study site to find out if you are eligible for reimbursement costs.

Find a Study Site Location Map