Do you or someone you know experience anxiety?

Consider participating in a clinical research study on anxiety

There is a growing need to find more treatment options for people with generalized anxiety disorder (GAD). Current treatment options can have side effects and the results can vary depending on the person.

There have been no new treatments for GAD for many years. It is important that we try to find new treatment options that can improve the symptoms.

The SEP361-226 study is investigating an investigational drug to see if it works in people with GAD. The study also examines how safe the investigational drug is and how the body reacts to it.

The Norwegian Health Authority has not yet approved this investigational drug for use. This is the first time it has been studied in people with GAD.

We are looking for people who:

  • are between 18 and 65 years old
  • have a diagnosis or symptom of GAD

The tablets with investigational drugs are taken by mouth at the same time every evening.

The study lasts up to 12 weeks and requires about eight visits to the study center. All study-related tests and medications are provided at no cost to you.

How can I get more information?

Contact the study team using the details below for more information. You choose yourself whether you want to participate in the study. The fact that you contact us does not mean that you have to participate in the study.

Ewa Karlsson, phone 0732-300 450 or email ewa.karlsson@probare.se


What does the study entail?

If you participate, you will be in the study for up to 12 weeks. Participants receive either the trial drug or a placebo (collectively referred to as the "study drug"). Placebo looks like the trial drug but contains no active ingredients.

The study drug tablets are taken by mouth at the same time each evening.

The study consists of three parts:

Screening period (up to three weeks)

  • You visit the study center once to see if the study is suitable for you and if you are eligible to participate.
  • The study staff will explain the sutdie requirements to you and let you decide whether you want to participate in the study or not.
  • If you want to participate, you will stop taking your current drug and switch to the study drug.

Study treatment period (approximately eight weeks)

  • You visit the study center six times for evaluations.
  • You take the study drug once a day.

Follow-up period (approximately one week)

  • After you have taken the last dose of the study drug, you will visit the study center one more time for final examinations.

Is there anything else I need to consider?

  • The study team will explain the possible benefits and risks of the study.
  • You do not have to participate in the study if you do not want to.
  • You can stop participating in the study at any time.
  • All investigational drug and all study-related tests are provided at no cost to you.
  • You may be reimbursed for reasonable travel and related expenses while participating in the study.
  • A team of doctors and nurses will carefully monitor your health during the course of the study.

Why is this study important?

People with GAD may feel anxious all the time and have trouble remembering the last time they felt calm. Current treatment options for GAD include medications, such as antidepressants and benzodiazepines. Antidepressants can have side effects and results can vary depending on the person. Benzodiazepines can be addictive.

Current treatments also have low remission rates and symptoms are likely to return within three years. There have been no new treatments for GAD for many years.

What is a clinical research study?

A clinical research study is a medical study that can help answer important questions about an investigational drug, including:

  • Is it working?
  • What amount, or dose, might work best?
  • How safe is it?
  • Are there any side effects?
  • All drugs must be tested in clinical research studies before they can be approved and prescribed to patients.

A broad selection of participants should be included in clinical research studies because certain diseases and drugs can affect people differently depending on age, gender, and ethnicity.

The decision to participate in a clinical research study is an important decision. If you have any questions, please contact the study team via the details above.