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Single Treatment With MM120 (Lysergide) in Generalized Anxiety Disorder: A Randomized Clinical Trial
Reid Robison1, Robert Barrow2, Craig Conant2
1Cedar Clinical Research, Draper, Utah.
JAMA
|September 4, 2025
Summary
A single dose of MM120 significantly reduced anxiety in adults with moderate to severe generalized anxiety disorder (GAD). Higher doses of MM120 showed a dose-dependent effect, supporting its potential as a GAD treatment.
Area of Science:
- Psychiatry
- Pharmacology
- Clinical Trials
Background:
- Generalized anxiety disorder (GAD) is a common psychiatric condition requiring effective treatments.
- Current pharmacotherapies for GAD necessitate ongoing research for improved efficacy and tolerability.
Purpose of the Study:
- To investigate the dose-response relationship of MM120 (lysergide D-tartrate) in adults experiencing moderate to severe GAD.
- To evaluate the efficacy of single doses of MM120 across a range of dosages compared to placebo.
Main Methods:
- A phase 2b, multicenter, randomized, double-blind, placebo-controlled study involving 198 adults with moderate to severe GAD.
- Participants received single doses of MM120 (25, 50, 100, or 200 µg) or placebo.
- The primary outcome was assessed by the change in Hamilton Anxiety Rating Scale (HAM-A) scores at 4 weeks, analyzed using the MCP-Mod method.
Main Results:
- Statistically significant reductions in HAM-A scores were observed at week 4 for the 100 µg and 200 µg MM120 dose groups compared to placebo.
- The 25 µg and 50 µg MM120 dose groups did not show a statistically significant difference from placebo.
- Adverse events, including visual perceptual changes, nausea, and headache, were dose-dependent and consistent with known effects.
Conclusions:
- A single administration of MM120 demonstrated a dose-dependent reduction in anxiety symptoms in patients with moderate to severe GAD.
- The findings support the efficacy of MM120 and provide crucial data for selecting optimal doses for future phase 3 trials.
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