Summary

Eligibility
for people ages 18-74 (full criteria)
Location
at UCSF
Dates
study started
completion around

Description

Summary

A Phase 3 Double-blind, Placebo-controlled Study (Part A) with an Open-label Extension (Part B) Evaluating MM120 Compared to Placebo in Generalized Anxiety Disorder - Voyage

Official Title

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, 12-Week Study (Part A) With a 40-Week Open-label Extension (Part B) Evaluating the Efficacy and Safety of Oral MM120 Compared to Placebo in the Treatment of Adults With Generalized Anxiety Disorder - Voyage

Details

The study will enroll up to 200 participants aged 18 to 74 years, inclusive with a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) confirmed primary diagnosis of GAD and a minimum HAM-A total score of at least 20 at Screening and Baseline without clinically relevant medical or psychiatric history.

The study consists of a 12-week randomized, double-blind, single-dose administration period evaluating MM120 versus placebo, followed by a 40-week extension phase with the opportunity for open-label treatment. During this phase, participants will be monitored and evaluated for potential treatment with MM120 based on pre-specified safety and symptom severity criteria.

Keywords

Generalized Anxiety Disorder, Anxiety Disorders, MM120 (LSD D-Tartrate)

Eligibility

You can join if…

Open to people ages 18-74

  1. Diagnosis of GAD per DSM-5
  2. Male or female aged 18 to 74
  3. HAM-A Total Score ≥20

You CAN'T join if...

  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

Locations

  • UCSF Department of Neurology accepting new patients
    San Francisco California 94158 United States
  • Pacific Neuroscience Institute not yet accepting patients
    Santa Monica California 90404 United States
  • Kadima Neuropsychiatry Institute accepting new patients
    La Jolla California 92037 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Mind Medicine, Inc.
ID
NCT06741228
Phase
Phase 3 Anxiety Research Study
Study Type
Interventional
Participants
Expecting 200 study participants
Last Updated