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<\/p>\nMaurizio Fava, MD<\/p>\n
Credit: Massachusetts General Hospital <\/p>\n
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A single 100 \u03bcg dose of MM120 (lysergide D-tartrate, LSD)<\/a> significantly reduced anxiety symptoms in adults with generalized anxiety disorder (GAD)<\/a>, with improvements sustained through 12 weeks, according to the first randomized, placebo-controlled trial of its kind published today in JAMA.1<\/p>\n \u201cThis study is a true turning point in the field of psychiatry,\u201d investigator Maurizio Fava, MD, member of the MindMed Scientific Advisory Board and chair of Mass General Brigham Department of Psychiatry, said in a statement.2 \u201cFor 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.\u201d<\/p>\n Despite 26 million adults in the US diagnosed with GAD, the US Food & Drug Administration (FDA) has not approved a new medication for this indication since 2007.2 However, 50% of patients fail first-line GAD treatments.<\/p>\n \u201cI 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,\u201d Fava continued.2 \u201cThese results highlight the promise of psychedelics in psychiatric medicine.\u201d<\/p>\n MindMed conducted MMED008, a multicenter, randomized, placebo-blind, phase 2b study evaluating a single administration of MM120 at 4 dose levels (25 [n = 39], 50 [n = 40], 100 [n = 40], or 200 [n = 40]) \u03bcg as monotherapy, without any psychotherapeutic intervention, in adults with moderate to severe GAD.1 The sample included 198 adults aged 18 \u2013 74 years (mean age, 41.3 years), with 56.7% female and 83% White (7.7% Black or African American and 3.6% Asian). The dose-response relationship was evaluated using the multiple comparison procedure modeling (MCP-Mod) method for change in Hamilton Anxiety Rating Scale at week 4.<\/p>\n The study met its primary endpoint, with MM120 demonstrating a dose-response relationship at week 4 with the 100 \u03bcg (least-squares mean difference, \u22125.0 points; 95% confidence interval [CI], \u22129.6 to \u22120.4 points) and the 200-\u03bcg (\u22126.0 points; 95% CI, \u22129.8 to \u22122.0 points) dose groups vs placebo. The study found no significant difference between the 25 \u03bcg (least-squares mean difference, \u22121.2 points; 95% CI, \u22126.0 to 3.5 points) and 50 \u03bcg (\u22121.8points; 95% CI, \u22127.6 to 4.0 points) doses compared with placebo.1<\/p>\n The trial also met its key secondary endpoint, demonstrating a significant symptom improvement versus placebo on the Hamilton Anxiety Rating Scale (HAM-A). The analysis showed that 100 \u03bcg was the optimal dose of MM120. At week 4, this dose achieved a 7.6-point greater reduction in HAM-A scores compared to placebo (-21.3 vs. -13.7; P 1<\/p>\n This study also met other secondary outcomes, including clinician-rated disease severity measured by the Clinical Global Impression-Severity (CGI-S) scale, changes from baseline in the Montgomery-\u00c5sberg Depression Rating Scale (MADRS), and measures of functional disability and quality of life.<\/p>\n On average, CGI-S scores improved from 4.8 to 2.2 in the 100 \u03bcg dose group, reflecting a 2-category shift from \u201cmarkedly ill\u201d to \u201cborderline ill\u201d at week 12. This was compared to a 4.9 to 3.5 improvement in the placebo group (P =.003).1<\/p>\n Furthermore, MM120 showed rapid clinical activity, working as early as day 2 and sustained through week 4 and 12. MM120 100 \u03bcg also led to significant MADRS improvement vs placebo, with a difference of 5.7 points at week 4 (P \u2264.05) and a difference of 6.4 points at week 12 (P \u2264.05).1<\/p>\n The safety profile of MM120 was comparable to previous findings, with mild-to-moderate adverse events occurring on dosing day. Common adverse events included visual perceptual changes, including illusion, pseudo-hallucination, and visual hallucination.1 These visual perceptual changes occurred in 46.2% of participants who received 25 \u03bcg of MM120, 75% who received 50 \u03bcg, 92.5% who received 100 \u03bcg, 100% who received 200 \u03bcg, and 10.3% who received a placebo.<\/p>\n Another common adverse event included nausea, occurring in 7.7% receiving 25 \u03bcg, 27.5% receiving 50 \u03bcg, 40% receiving 100 \u03bcg, 60% receiving 200 \u03bcg, and 7.7% receiving placebo.1 Headaches occurred in 12.8%, 22.5%, 35.0%,27.5%, and 23.1% of participants, respectively.<\/p>\n The dose-response results inform MindMed\u2019s ongoing phase 3 trial focusing on the MM120 Orally Disintegrating Tablet (ODT). Topline results for MindMed\u2019s Voyage trial, evaluating the efficacy, durability, and safety of MM120 ODT for GAD, are expected in the first half of 2026.2<\/p>\n \u201cOur Phase 2b results\u2014marking the first well-controlled clinical study to evaluate dose-response relationships of LSD in a psychiatric population\u2014demonstrate the meaningful impact of a single 100 \u03bcg dose of MM120 in significantly reducing anxiety symptoms,\u201d said Daniel Karlin, MD, chief medical officer of MindMed.2<\/p>\n References<\/strong><\/p>\n\n