New medication for generalized anxiety disorder enters Phase III trials in the U.S.

Deramciclane is being investigated in U.S. and European Phase III trials as a treatment for generalized anxiety disorder. The U.S. trial will compare the investigational agent, a new type of serotonin reuptake inhibitor, with venlafaxine hydrochloride, an antidepressant approved in the U.S. that also works through serotonin brain receptors.

Symptoms of generalized anxiety disorder can be so severe that 4 percent to 7 percent of the population of industrialized countries is considered crippled by it at any given time. American investigators, who are currently enrolling patients, hope they will see results as promising as those seen in the European trials, which were initiated in 2000.

Harold Urschel III, M.D., who heads one center in the 20-center U.S. trial, said "We have treatments now for generalized anxiety disorder, but we need new ones for our patients -- treatments that work better and with fewer side effects and aren't addictive like some of the older medications."

The 12-week, double-blind study will compare daily treatments of 30 mg of deramciclane or 60 mg of deramciclane with 30 mg of venlafaxine and a placebo. The 900 treatment volunteers will be divided into four groups, each receiving one treatment. The study will also look at the effects of drug withdrawal.




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