RE104 for Generalized Anxiety Disorder

This research study is evaluating a single dose of an investigational psychedelic medication vs. placebo to see if it may help reduce symptoms of generalized anxiety disorder (GAD).

If you live with generalized anxiety disorder, you know anxiety isn't limited to stressful moments. Ongoing worry can affect how you feel, think, and manage daily life.

You may relate to symptoms such as:

• Uncontrollable worry and anxiety about everyday things
• Feeling irritable or "on edge" frequently
• Having difficulty concentrating
• Restlessness, trouble relaxing, and/or sleeping difficulties

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A research study evaluating a single dose of an investigational psychedelic medication compared to placebo may be an option for you.

Please continue reading to learn more about The RECLAIM Study and what participation involves.

Recognizing Symptoms of Generalized Anxiety Disorder

GAD can look different for everyone, but common signs may include:

Excessive worry about everyday things

• Excessive worry about everyday things
• Trouble controlling worries and nervousness
• Feeling irritable or easily frustrated
• Difficulty concentrating, or feeling that your mind "goes blank"
• Overthinking plans and solutions to all possible worst-case outcomes
• Indecisiveness and fear of making the wrong decision
• Feeling situations or events are threatening, even when they aren't

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GAD can also cause physical symptoms including:

• Fatigue
• Trouble falling asleep or staying asleep
• Muscle tension or aches
• Trembling or feeling twitchy
• Sweating or being easily startled
• Nausea or other gastrointestinal symptoms

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If you recognize these symptoms in yourself, please consider whether participating in The RECLAIM Study might be right for you.

What Will Happen If I Participate in The RECLAIM Study?

Participation in The RECLAIM Study is voluntary. Interested potential study participants will be screened at a Study Center where they will be assessed to ensure they meet all eligibility criteria and can participate safely.

Eligible participants will receive a single injection under the skin at the Study Center and will be monitored in a comfortable environment. Study Participants will have a 50/50 chance (like the flip of a coin) of being assigned to either the study drug or placebo, a substance that looks like the study drug but has no active ingredients. After the treatment session, Study Participants will be followed for 12 additional weeks with follow-up visits over the phone and in person to help monitor safety and well-being.

What Type of Study Drug Is Being Evaluated?

The study is evaluating the safety and effects of an investigational study drug in adults with generalized anxiety disorder (GAD). The study drug is structurally similar to psilocybin (a drug with psychoactive properties) that may help ease psychiatric symptoms of GAD.

Why This Research Matters

Doctors have several prescription treatment options for generalized anxiety disorder (GAD). Antidepressants are often used as the first treatment for the symptoms of GAD. However, in some people, these treatments may not provide enough relief from excessive worry and other GAD symptoms.

This is why there is a need for new treatment options for GAD. Since so many people's symptoms may not respond to these currently available treatments, there is still a need for other therapies that are safe and effective.

Before new medications can be approved for public use, they must be tested in research studies like this one. Research studies help us explore potential new treatments for people living with GAD. Your participation could help shape the future of care.

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