A sense of calm in bipolar disorder: The clinical trials of lithium
In 1949, the Australian physician John Cade published a paper on using lithium salts to treat psychotic mania, noting that the drug produced a “pronounced calming effect” . The publication piqued great interest among the psychiatry community, but large multicenter clinical studies were needed to confirm lithium’s role as a potential new tool in the treatment of mania associated with bipolar disorder.
In the decades following Cade’s publication, the National Institute of Mental Health (NIMH) and several university centers established large, rigorously controlled, multicenter clinical trials that clearly demonstrated the antimanic effects of lithium. The ability to convene, lead, and analyze data from these trials contributed to the FDA’s 1970 approval of lithium to treat acute mania.
More than 60 years after its discovery, lithium is still the first-line therapy for treatment of bipolar disorder. In addition to being tremendously successful in treating the illness, lithium provides enormous financial savings by reducing the lost productivity of affected earners, homemakers, caregivers, and other individuals by billions of dollars annually .
1970 Eskalith Approval: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.DrugDetails.