A Phase 3 Trial of MM120 for Generalized Anxiety Disorder (Voyage)

Launched by MIND MEDICINE, INC. · Dec 16, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called MM120 for people with Generalized Anxiety Disorder (GAD). GAD is a condition where individuals experience excessive worry about everyday issues, which can be very distressing. The trial is split into two parts: the first part compares MM120 to a placebo (a dummy treatment that has no active ingredients) to see if MM120 is more effective. The second part allows participants to continue receiving MM120 after the initial comparison period.

To be eligible for this trial, participants must be between 18 and 74 years old and have a diagnosis of GAD. They should also have a certain level of anxiety, as measured by a questionnaire. However, people with other serious mental health issues, a family history of certain disorders, or substance use problems are not eligible. If someone joins the trial, they can expect regular check-ins with healthcare professionals to monitor their progress and side effects. Overall, this study aims to find out if MM120 can help those struggling with GAD and improve their quality of life.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Diagnosis of GAD per DSM-5
• • 2. Male or female aged 18 to 74
• • 3. HAM-A Total Score ≥20
• Exclusion Criteria:
• • 1. Certain psychiatric disorders (other than generalized anxiety disorder)
• • 2. First degree relative with or lifetime history of a psychotic disorder or bipolar disorder
• • 3. Current diagnosis of alcohol or substance use disorder (excluding nicotine and caffeine)
• • 4. Any clinically significant unstable illness