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MM120 for Generalized Anxiety Disorder

Phase 3

Recruiting

Research Sponsored by Mind Medicine, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Are you willing to abstain from cannabis use for at least 12 weeks while you participate in the study?

Are you willing to use contraception throughout the study period?

Must not have

Have you used psychedelics in the past 2 years? e.g. LSD, MDMA, DMT, psilocybin, ayahuasca, mescaline, mushrooms, ecstasy

Have you or an immediate family member (child, sibling, parent) ever been diagnosed with Schizophrenia or Bipolar Disorder?

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Summary

The reason for this study is to see if the investigational study drug, called MM120, can help people with Anxiety compared to a placebo. A placebo is an inactive drug that looks like MM120 but does not contain any active ingredients.

Who is the study for?

This study is for adults, who are 18-74 years old, with Generalized Anxiety Disorder who are in good health. You may not be able to participate if you have certain psychiatric or health disorders, are taking prohibited medications or are unwilling to use contraception for the duration of the study.

What is being tested?

MM120 is a study drug that acts on serotonin in your brain. Researchers believe that MM120 could have possible benefits that may improve your general anxiety symptoms.

What are the potential side effects?

MM120 is at a research stage, so it may have side effects that are not known at this time. As with any investigational new drug, there is a risk that unexpected adverse effects may occur. Almost all drugs, both old and new, can cause reactions. The possible side effects you may experience when receiving treatment may include and typically resolve within 24 hours of dosing: illusion (changes in how you see, hear or feel things present around you), nausea, euphoric mood, headache, visual hallucination (seeing things that are not present), anxiety, excessive sweating, dilated pupils, increased blood pressure, abnormal thinking, fatigue and feeling unstable on your feet.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This study's timeline: screening for a total of 3 weeks, Double Blind Period for a total of 12 weeks, and an Open Label Extension for a total of 56 weeks.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To evaluate the efficacy of a single dose of MM120 versus placebo on anxiety symptoms in adults with GAD

Secondary study objectives

To evaluate the efficacy of a single dose of MM120 versus placebo on additional measures of anxiety, functioning and quality of life in adults with GAD