Single-Dose LSD Therapy Shows Promise for Generalized Anxiety Disorder

In a multicenter, parallel, randomized, placebo-controlled, double-blind, phase 2b MMED008 study, MM120 (lysergide D-tartrate, LSD; Mind Medicine) demonstrated a dose-response relationship and significant symptom improvement compared to placebo for the treatment of moderate-to-severe generalized anxiety disorder (GAD).^1,2

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“This study is a true turning point in the field of psychiatry,” Maurizio Fava, MD, study author, member of the MindMed Scientific Advisory Board and chair of the Mass General Brigham Department of Psychiatry, said in a news release. “For the first time, LSD has been studied with modern scientific rigor, and the results are both clinically meaningful and potentially paradigm-shifting for the treatment of GAD.”¹

Generalized Anxiety Disorder

Individuals with GAD experience continuous overwhelming worry that is difficult to manage, presenting signs like panic disorder, obsessive-compulsive disorder, and other forms of anxiety. Physical symptoms include fatigue, muscle tension, trouble concentrating, and difficulty sleeping. Anxiety symptoms include worrying about a number of areas that are out of proportion to the impact of the events; overthinking plans and solutions to worst-case outcomes; difficulty handling uncertainty; indecisiveness; inability to set aside or let go of a worry; inability to relax; and difficulty concentrating.³

Other conditions such as major depressive disorder (MDD) and post-traumatic stress disorder (PTSD) often overlap with GAD, with nearly 50% of individuals also having MDD. This co-occurrence is linked to higher health care costs, including increased drug costs. Despite the availability of multiple approved medications for GAD, many patients do not find relief.³

“GAD affects 26 million adults in the US, yet no new medications have been approved since 2007—and first-line treatments fail 50% of patients. I have seen firsthand the devastating toll GAD takes on patients and their families, which is why it is so significant that a single dose of MM120 delivered rapid, robust, and lasting effects. These results highlight the promise of psychedelics in psychiatric medicine and represent a critical step toward expanding effective options for those who are suffering,” Fava said in the news release.¹

Role of the MM120 Orally Disintegrating Tablet

MM120 is a synthetic ergotamine associated with psychedelics, which acts as a partial agonist at human serotonin-2A (5-HT2A) receptors. The dose-response, safety, efficacy, and tolerability of a single dose of the drug were assessed in the phase 2b study, which included 198 adults with GAD that were randomly assigned to receive equal single treatment with MM120 25, 50, 100, or 200 µg as a monotherapy. Researchers used the Hamilton Anxiety Rating Scale (HAM-A)—a clinical tool used to assess the severity of anxiety.¹

The results demonstrated that MM120 showed a significant dose-dependent effect on reducing anxiety symptoms, measured by HAM-A. The 100 µg and 200 µg doses of MM120 significantly improved HAM-A scores compared to a placebo. Specifically, the 100 µg doses resulted in a 7.6-point improvement, while the 200 µg dose showed a 5.5-point improvement. However, lower doses did not show a statistically significant effect.¹

“Our phase 2b results—marking the first well-controlled clinical study to evaluate dose-response relationships of LSD in a psychiatric population—demonstrate the meaningful impact of a single 100 µg dose of MM120 in significantly reducing anxiety symptoms,” Daniel R. Karlin, MD, MA, chief medical officer of MindMed, said in the news release.¹

Adverse effects of MM120 were consistent with those expected from LSD, including visual changes, nausea, and headaches, according to study authors.¹

“These findings confirm that LSD can be rigorously studied and help catalyze a long-overdue transformation in the field of psychiatry. With enrollment underway in our Phase 3 Voyage, Panorama, and Emerge trials, we’re eager to further evaluate MM120 ODT’s potential to treat the two most common psychiatric disorders—GAD and MDD—affecting over 60 million people in the US,” Karlin said in the news release.¹

REFERENCES

1. Journal of the American Medical Association (JAMA) Publishes Results from First-Ever Randomized, Placebo-Controlled Clinical Trial Assessing the Dose-Dependent Efficacy of MM120 (Lysergide D-Tartrate, LSD) in Generalized Anxiety Disorder (GAD). Business Wire. News release. September 4, 2025. Accessed September 9, 2025. https://www.businesswire.com/news/home/20250904867044/en/Journal-of-the-American-Medical-Association-JAMA-Publishes-Results-from-First-Ever-Randomized-Placebo-Controlled-Clinical-Trial-Assessing-the-Dose-Dependent-Efficacy-of-MM120-Lysergide-D-Tartrate-LSD-in-Generalized-Anxiety-Disorder-GAD

2. Generalized anxiety disorder. Mayo Clinic. News release. October 13, 2017. Accessed September 9, 2025. https://www.mayoclinic.org/diseases-conditions/generalized-anxiety-disorder/symptoms-causes/syc-20360803