Do You Struggle with Social Anxiety?

We are studying an investigational oral medication used on demand to treat social anxiety disorder. See if the AFFIRM-1 Study is right for you.

A girl with social anxiety disorder stands with her hands covering her eyes while panicking in a crowded public space during the middle of the day.

The AFFIRM-1 Study – Now Enrolling

Its normal to feel nervous in some social situations – whether speaking in public, meeting new people, or starting a new job. But for millions of adults, these everyday interactions cause sever anxiety, self-consciousness, or avoidance – a condition known as social anxiety disorder (SAD). Social anxiety disorder is more than just shyness – some examples include:

✅ Excessive self-consciousness in everyday social situations

✅ Intense worry for days or weeks before an upcoming social situation
✅ Fear of being judged by others or being the center of attention
✅ Avoiding social situations entirely

If you get anxious in social situations or being the center of attention, you may qualify for the AFFIRM-1 Study, a new research study being conducted at select centers across the U.S. The study is exploring the effect of an investigational oral medication when used on demand to treat symptoms of social anxiety disorder.

The study lasts about 3 weeks and involves 2 visits to your local study center (you will receive a payment for completing each of these visits). Your first visit, called the Screening Visit, will help determine if you qualify to join the study. If you qualify and wish to continue, you will return for a second visit, the Treatment Visit. At this visit, you will take the study medication and will be asked to complete some questionnaires and other assessments related to your anxiety.

Participants in the AFFIRM-1 Study will receive all study-related care at no cost and will be compensated for their time and travel to attend up to 2 visits over a 3-week period.

A clinical trial is a carefully designed research study involving human volunteers to investigate the safety and effectiveness of a new drug or treatment. Clinical trials are essential for evaluating the benefits and risks of medical interventions, ultimately informing healthcare decisions and regulatory approvals.

As a clinical trial or observational study participant, your responsibilities and what you will be required to do can vary depending on the study, its objectives, and the phase of the trial.

Some common activities and responsibilities you may encounter as a participant include: diagnostic tests, treatments, procedures, doctor visits, dietary changes, exercise and/or other lifestyle changes. Observational studies often involve minimal effort, such as completing questionnaires, sharing test results, maintaining a diet or exercise log.

Joining a clinical trial can provide access to cutting-edge treatments, close medical monitoring, and an opportunity to contribute to medical knowledge. Participants may experience improved health outcomes and specialized care while potentially receiving compensation for volunteering.

Clinical trials are designed with a strong emphasis on the safety of participants, and multiple safeguards are in place to minimize risks, including careful study design, oversight by institutional review boards and routine monitoring of study data by independent experts. Researchers must inform participants of the risks, benefits and/or side effects they discover.

Yes, you can drop out of a clinical trial study at any time, and you have the right to do so without facing any penalties or consequences. This is often referred to as "withdrawal of consent."

Voluntary participation is a fundamental principle of clinical research. You are not obligated to continue in a trial if you no longer wish to do so.

Determining your eligibility to participate in a clinical trial involves a thorough evaluation of specific eligibility criteria set forth by the study's researchers and sponsors. The criteria help define the patient population being studied and are designed to protect the safety of participants in the trial.

Providing accurate information about your medical history and health status is crucial for your safety and the integrity of the research. If you are not eligible for one trial, you may still be eligible for other trials in the future, so it's worth exploring your options if you are interested in participating in clinical research.