The first patient has been dosed in the phase 2b dose-optimization trial of a pharmaceutically optimized form of LSD for the treatment of generalized anxiety disorder.
The first patient received a dose of a pharmaceutically optimized form of lysergic acid diethylamide (LSD) in the phase 2b dose-optimization trial for MM-120 for the treatment of generalized anxiety disorder (GAD), according to biopharmaceutical company MindMed.1
"The initiation of our phase 2b clinical trial, the largest well-controlled clinical trial of LSD ever conducted, represents a major milestone for MindMed and for the many patients suffering from GAD," said Robert Barrow, Chief Executive Officer and Director of MindMed. "This exciting next step in the advancement of LSD builds on the positive topline data presented by our partners at University Hospital Basel in May 2022, which demonstrated the rapid, durable, and statistically significant effects of LSD and its potential to safely mitigate symptoms of anxiety and depression. The results of our phase 2b trial will guide the dose selection and development strategy for our pivotal phase 3 clinical trials, as we continue our efforts to bring a new potential treatment to the millions of people living with GAD."
The phase 2b trial is a multi-center, parallel, randomized, double-blind, placebo-controlled, dose-optimization study. Investigators plan to enroll 200 participants who will receive either a single administration of up to 200 µg of MM-120 or placebo. The primary objective is to determine the reduction in anxiety symptoms 4 weeks after a single administration of MM-120, compared across the 5 treatment arms. Key secondary objectives, measured up to 12 weeks after the single administration, include assessments of safety and tolerability as well as quality of life.
Earlier this year, the American Psychiatric Association put out its official statement on psychedelics, encouraging research of this kind: “There is currently inadequate scientific evidence for endorsing the use of psychedelics to treat any psychiatric disorder except within the context of approved investigational studies. APA supports continued research and therapeutic discovery into psychedelic agents with the same scientific integrity and regulatory standards applied to other promising therapies in medicine.”2
If you are interested in reading more about psychedelics, check out our February front cover “Psychedelics and the Future of Psychiatry,” and coverage from our recent 2022 Annual Psychiatric Times™ World CME Conference, “The Recent Resurgence of Psilocybin: Is It Here to Stay?” Look forward to the Psychiatric Times™ Psychedelic Supplement, coming in September.
1. MindMed announces first patient dosed in phase 2b trial of mm-120 in generalized anxiety disorder. News release. PR Newswire. August 25, 2022. https://www.prnewswire.com/news-releases/mindmed-announces-first-patient-dosed-in-phase-2b-trial-of-mm-120-in-generalized-anxiety-disorder-301612131.html
2. Position statement on the use of psychedelic and empathogenic agents for mental health conditions. American Psychiatric Association. July 2022. Accessed August 25, 2022. https://www.psychiatry.org/getattachment/d5c13619-ca1f-491f-a7a8-b7141c800904/Position-Use-of-Psychedelic-Empathogenic-Agents.pdf