The first administration of this study drug, which may contain either the active investigational compound LSD or matching placebo, was performed at Psyon on October 6, 2025, as part of this clinical trial investigating its effects on GAD. Additional doses will be administered in the upcoming weeks and months, in accordance with the study protocol (the next administration took place on October 13, 2025). This Phase 3 study aims to evaluate the efficacy and safety of this novel therapeutic approach for the treatment of GAD.
“LSD is one of the most potent psychedelics and has become an icon of psychedelic research from a previous era, during which many studies suggested its therapeutic potential. This current study is notable in that it targets patients suffering from chronic anxiety, unlike most psychedelic studies which predominantly focus on depression. A key feature is the patient-centric design of the trial: if participants do not respond to the first dose of the study drug (active or placebo), they may repeat the treatment up to four times over the course of a year depending on their clinical response, with all subsequent sessions delivering the active drug,” explains MUDr. Filip Tylš, Ph.D., the principal investigator for MindMed’s study.
Generalized Anxiety Disorder (GAD)
Generalized Anxiety Disorder (GAD) is a chronic condition characterized by persistent and excessive anxiety that is not restricted to specific situations and lasts for at least six months. It involves a broad range of psychological and physical symptoms with a significant impact on daily functioning. Symptoms include persistent worry, restlessness, difficulty concentrating, irritability, muscle tension, and sleep disturbances.
The Study and Its Objectives
The MindMed Phase 3 clinical trial evaluates the effects of the study drug (LSD D-tartrate) in adults diagnosed with generalized anxiety disorder (GAD).
The primary objectives are to monitor the efficacy and safety of the study drug in this patient population and to determine whether this investigational psychedelic compound can provide a new treatment option for this challenging anxiety disorder.
Participants are randomly assigned to receive either study drug or matching placebo in a double-blind design, meaning neither the patient nor the clinician knows which treatment is administered. The trial assesses changes in anxiety symptoms and the safety profile of the treatment. All participants must meet diagnostic criteria for generalized anxiety disorder.
Study Sponsor
The study is sponsored by Mind Medicine, Inc. (MindMed). MindMed is a late-stage clinical biopharmaceutical company developing novel product candidates to treat brain health disorders.
Do you want to learn more about the study?
For information about possible participation in the study, please contact us at klinickahodnoceni@psyon.cz.
Further information about the study can be found on our websites, on Clinicaltrials.gov, or MindMed.