Swiss LSD Study Team Submits Annual Report to FDA; Study Nears Completion
On May 3, 2011, our clinical research team submitted to the FDA the annual report for our nearly-completed Swiss study of LSD-assisted psychotherapy for anxiety associated with advanced life-threatening illness. Annual reports are designed to give the FDA an overview of completed, ongoing, and planned studies for specific Investigational New Drug (IND) applications. In our report, which covered all study activity between February 28, 2010, and February 28, 2011, we provided information about enrollment (including the total number of subjects enrolled for each study), demographics (such as height, weight, race, and illness), amendments to the study protocol, and the occurrence of serious and severe adverse events. Although there have been three serious adverse events over the course of the study, they were related to disease progression or accidents and not to administration of LSD.
On May 26, 2011, the 12th and last subject will undergo his last experimental therapy session. The MAPS clinical team is conducting a preliminary data analysis and finalizing the clinical database for the FDA. Statisticians at the University of Zurich working with Franz Vollenweider, M.D., will be conducting the analysis to assist Clinical Investigator Peter Gasser, M.D., in preparing a manuscript for publication.