MM120 for Generalized Anxiety Disorder (Voyage Trial)

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

Male or female: must be between 18 (or the legal age of consent in the jurisdiction in which the study is taking place) and 74 years of age inclusive, at the time of signing the informed consent

Diagnosis of GAD per DSM-5

Must not have

First degree relative with or lifetime history of a psychotic disorder or bipolar disorder

Any clinically significant unstable illness

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 8, week 4, week 2, and week 1

Awards & highlights

Pivotal Trial

Summary

This trial is testing a new medication called MM120 for Generalized Anxiety Disorder. It will compare the effects of MM120 to a placebo in a large study.

Who is the study for?

This trial is for adults aged 18 to 74 with Generalized Anxiety Disorder (GAD) as defined by DSM-5, and who are notably anxious (HAM-A score ≥20). It's not open to those with other psychiatric conditions, a family history of psychosis or bipolar disorder, substance abuse issues (except nicotine/caffeine), or any serious unstable illness.

What is being tested?

The study tests MM120 (LSD D-Tartrate), a potential new treatment for anxiety against a placebo. Part A is blind and controlled—participants won't know if they're getting the real drug or placebo. Part B allows all participants to receive MM120 openly.

What are the potential side effects?

While specific side effects of MM120 aren't listed here, LSD-related treatments can potentially cause sensory alterations, mood changes, fatigue, headaches and may affect mental health stability.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am between 18 and 74 years old.

Select...

I have been diagnosed with Generalized Anxiety Disorder.

Exclusion Criteria

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

Select...

A close family member has had psychosis or bipolar disorder.

Select...

I do not have any unstable illnesses.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 8, week 4, week 2, and week 1

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 8, week 4, week 2, and week 1

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 8, week 4, week 2, and week 1 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change from Baseline in Hamilton Anxiety Rating Scale (HAM-A) total score at Week 12

Secondary study objectives

CSFQ-14 total score at each timepoint assessed during the open-label period

Change from Baseline in HAM-A total score at Week 8, Week 4, Week 2, and Week 1

Change from Baseline in the Changes in Sexual Functioning Questionnaire (CSFQ-14) total score at each timepoint assessed during the double-blind period

+20 more