MM120 for Generalized Anxiety Disorder

Verified Trial

Phase 2

Waitlist Available

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 avoid cannabis use during this 4 month study?

Do you have a friend or family member who will be able to meet you at the study clinic and drive you home after your single dosing day?

Must not have

Have you ever been diagnosed with PTSD?

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

Timeline

Screening 30 days

Treatment 1 day

Follow Up 12 days

Summary

This trial is testing whether MM120 (LSD) can help people with generalized anxiety disorder. The study examines the effects of MM120 on generalized anxiety disorder. LSD affects the brain's serotonin system, potentially altering mood and anxiety. LSD was investigated for MDD, anxiety, and severe somatic disorders.

Who is the study for?

This trial is for adults with Generalized Anxiety Disorder who are in good health and have a BMI between 18 and 38 mg/kg2. It excludes those with certain psychiatric disorders or family history of them, pregnant or breastfeeding women, men unwilling to use contraception, anyone at significant suicide risk or taking prohibited medications.

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 severe reactions. The possible mild to moderate side effects you may experience when receiving treatment with MM120 at 100 μg may include and typically resolve by end of session or 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 by anxiety (anxiety hyperhidrosis), dilated pupils (Mydriasis), 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 ~ 30 days1 visit

Treatment ~ 1 day1 visit

Follow Up ~ 12 days6 visits

Screening ~ 30 days

Treatment ~ 1 day

Follow Up ~12 days

This trial's timeline: 30 days for screening, 1 day for treatment, and 12 days for reporting.

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