Your experience matters, help advance anxiety research

Living with generalized anxiety disorder (GAD) can feel overwhelming. Constant worry, restlessness, and fatigue can make even simple daily tasks difficult. If you’ve been searching for new ways to manage your anxiety, you may be eligible for a clinical research study exploring a potential treatment for GAD.

If anxiety is impacting your life, this study may offer an opportunity to explore new treatment options while helping researchers learn more about GAD. Otsuka, the study sponsor, will provide the investigational drug at no cost.

Study Overview

We are looking for adults with symptoms of generalized anxiety disorder (GAD) to part in the GAD study.  

More than half of individuals with anxiety symptoms are not receiving treatment, often because current therapies may not be effective enough or cause unpleasant side effects. This study is researching a potential new treatment option that could help improve the management of anxiety symptoms.    

We are dedicated to supporting research that could affect the future of the millions struggling with the difficult symptoms of anxiety.  

See if you qualify: Take the pre-screening questionnaire.

What is Generalized Anxiety Disorder (GAD)? 
GAD is a common mental health disorder where your body has difficulty controlling feelings of excessive worry. It affects about 6.8 million people in the U.S., yet less than half receive treatment for their symptoms. 

Possible symptoms of GAD include: 
Persistent worry that is difficult to control 

• Feeling restless, tense, or on edge  
• Trouble concentrating or feeling fatigued 
• Irritability or trouble sleeping 
• Physical symptoms such as headaches, muscle aches, or stomach discomfort 

Who can join the study?

We are looking for adults with symptoms of anxiety to take part in this research study. Have you been struggling with anxiety; this may be an opportunity to help advance medical research while receiving study-related care at no cost.  

You may be eligible if you: 

  • Are between 18 and 65 years old 

  • Diagnosed with Generalized Anxiety Disorder (GAD) 

  • Currently or have previously been treated for anxiety 

  • Experience symptoms of generalized anxiety, such as: 

    • Uncontrolled or excessive worry 

    • Restlessness or feeling on edge 

    • Trouble concentrating or fatigue 

    • Irritability or difficulty sleeping 

    • Some people may also experience headaches, muscle aches, or stomach discomfort 

There will be other study requirements that the study team will discuss with you. 

What to expect if you join: 

  • Regular check-ins with a healthcare professional during your 3 months of participation 

  • Receive the investigational drug or placebo at no cost

  • Compensation may be provided for time and study-related expenses  

*Placebo is a substance that looks just like the investigational drug but contains no active ingredients 

See if you qualify: Take the pre-screening questionnaire.

What to expect when joining the study?

The pre-screening process 
If you are interested in joining a clinical trial, the first step is to learn about the study and see if you meet the initial qualifications. All you’ll have to do is fill out the short online questionnaire below to see if this study is a good fit for you.  

If you pass the online pre-screening questionnaire, you'll be connected to a research study site near you. The research study site will reach out to you directly. 

Take the pre-screening questionnaire.

Finding a research study site 
A healthcare professional and research team at the trial site will provide additional information and guide you through the next steps.  

Study sites conducting the study can be found here: ClinicalTrials.gov

You do not have to join the study if you do not want to, and you can change your mind at any time. 

The screening and informed consent process 
If you meet the pre-qualifications, you’ll be invited to the research study site for an in-person visit to learn more about the study.  

At your appointment, a healthcare professional and research team will explain all the details of the study, including any risks for participating. They will also answer any questions you may have.  

If you are interested in joining the study after speaking with a healthcare professional and research team, you will be asked to sign an informed consent document, which confirms you have agreed to participate in the study and complete all the necessary study assessments.    

The study treatment period 
During the Study Treatment Period, you will be placed into 1 of 2 study groups to receive either the investigational drug or the placebo. Group assignment is done at random, like flipping a coin.  

The follow-up period 
The follow-up period will take place after you stop receiving the investigational drug. During this period, the research team will continue to learn about the safety and effectiveness of the investigational drug.  

Study activities and assessments will vary at each visit, but may include: 

• Mental health questionnaires 
• Physical exams 
• Questions about how you are feeling 

Frequently Asked Questions

  • Clinical research is the process of testing and developing medicines to potentially prevent, treat, or manage diseases. Before any medicine becomes FDA-approved and available, it must undergo clinical trials to ensure safety and effectiveness.

  • The goal of this study is to determine how effective the investigational drug is at reducing symptoms of anxiety and how safe it is for adults who have generalized anxiety. 

  • You’ll help us learn about the investigational drug to see if it could potentially be a new option for adults experiencing generalized anxiety. 

  • No. All study-related care is provided at no cost, and you do not need health insurance to participate. You will not have to pay for the investigational drug, but your regular medications will not be paid for as part of the study.

  • Yes. Taking part in a study is always your choice. You can change your mind or stop taking part at any time, for any reason.

  • Here are some useful links to find important information about generalized anxiety: 

  • All participant data will be kept confidential and used only for research purposes. We follow strict privacy and security guidelines to keep your information safe.