Not currently recruiting at University of California Health

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

a study on Anxiety

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 open-label extension (OLE) during which participants will be monitored and evaluated for potential retreatment 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. 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.
  2. Diagnosis of GAD per DSM-5.
  3. HAM-A Total Score ≥20.

You CAN'T join if...

  1. Any psychiatric disorder (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.

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Locations

  • UCSF Department of Neurology not yet accepting patients
    San Francisco California 94158 United States
  • Pacific Neuroscience Institute not yet accepting patients
    Santa Monica California 90404 United States
  • Kadima Neuropsychiatry Institute not yet accepting patients
    La Jolla California 92037 United States
  • Cedar Clinical Research accepting new patients
    Draper Utah 84020 United States
  • Mountain View accepting new patients
    Denver Colorado 80209 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
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